Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2026-01-02 @ 2:08 PM
Study NCT ID:
NCT02739035
Status:
COMPLETED
Last Update Posted:
2023-11-21
First Post:
2016-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MUA to Treat Postoperative Stiffness After Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'D000068579', 'term': 'Celecoxib'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'schouten.gabriel@mayo.edu', 'phone': '5072665895', 'title': 'Gabriel Schouten - Clinical Research Coordinator', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Participant dropout rates were higher than anticipated for in the initial enrollment calculations, and patient reported outcome surveys had low completion rates. As a result, the target of 90 power for results was not achieved for all study outcome metrics. Additional study is warranted regarding NSAID administration strategy for MUA patients in order to determine if NSAIDs can be useful in combatting the inflammatory cascade which is associated with arthrofibrosis and post TKA stiffness.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored throughout the study from the beginning of enrollment until both the 6-months post-manipulation under anesthesia and 1-year post-manipulation under anesthesia timepoints had been reached. Approximately 1 year.', 'description': 'All sites conducted monitoring for adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'MUA Alone', 'description': 'Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'MUA With Dexamethasone and Celecoxib', 'description': 'For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.\n\nDexamethasone: 8 mg of IV dexamethasone immediately before MUA.\n\nCelecoxib: 2 weeks per mouth of celecoxib (200 mg daily)', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 1, 'seriousNumAtRisk': 72, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Head Injury', 'notes': 'Patient sustained a head injury resulting in a concussion and eye contusion while enrolled in the study. This was reported to the Data and Safety Monitoring Board and deemed unanticipated but not serious or related to the study procedure.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Knee Range of Motion After Manipulation Under Anesthesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MUA Alone', 'description': 'Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.'}, {'id': 'OG001', 'title': 'MUA With Dexamethasone and Celecoxib', 'description': 'For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.\n\nDexamethasone: 8 mg of IV dexamethasone immediately before MUA.\n\nCelecoxib: 2 weeks per mouth of celecoxib (200 mg daily)'}], 'classes': [{'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000', 'lowerLimit': '60', 'upperLimit': '125'}, {'value': '101.2', 'groupId': 'OG001', 'lowerLimit': '75', 'upperLimit': '124'}]}]}], 'analyses': [{'pValue': '0.23', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Using a standard alpha value of 0.05, p values below 0.05 were considered statistically significant.', 'groupDescription': 'Outcomes were compared between the two study groups using two-sample t-tests. T-tests were two-sided and the standard alpha value of 0.05 was the threshold for statistical significance.\n\nThe null hypothesis was that there were no significant differences between control group of MUA alone and the treatment group of MUA with dexamethasone and celecoxib.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A difference of 10 degrees in total mean range of motion between the control and the treatment group was considered a clinically significant improvement.'}], 'paramType': 'MEAN', 'timeFrame': '6 weeks after manipulation', 'description': 'Knee range of motion after manipulation will be measured in degrees as the total arc of motion from maximum passive flexion to maximum passive extension.', 'unitOfMeasure': 'Degrees', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who were able to complete follow-up and have range of motion measured.'}, {'type': 'PRIMARY', 'title': 'Knee Range of Motion After Manipulation Under Anesthesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MUA Alone', 'description': 'Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.'}, {'id': 'OG001', 'title': 'MUA With Dexamethasone and Celecoxib', 'description': 'For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.\n\nDexamethasone: 8 mg of IV dexamethasone immediately before MUA.\n\nCelecoxib: 2 weeks per mouth of celecoxib (200 mg daily)'}], 'classes': [{'categories': [{'measurements': [{'value': '107.7', 'groupId': 'OG000', 'lowerLimit': '54', 'upperLimit': '135'}, {'value': '107.6', 'groupId': 'OG001', 'lowerLimit': '70', 'upperLimit': '130'}]}]}], 'analyses': [{'pValue': '0.81', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Using a standard alpha value of 0.05, p values below 0.05 were considered statistically significant.', 'groupDescription': 'Outcomes were compared between the two study groups using two-sample t-tests. T-tests were two-sided and the standard alpha value of 0.05 was the threshold for statistical significance.\n\nThe null hypothesis was that there were no significant differences between control group of MUA alone and the treatment group of MUA with dexamethasone and celecoxib.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': "A difference of 10 degrees in total mean range of motion (ROM) between the control and the treatment group was considered a clinically significant improvement. To detect this difference, a previous study's mean and standard deviation were referenced in order to predict the variation of results. 54 patients per arm were required to have 90% power with a two-sided t-test and a type I error rate of 5%. 130 patients were targeted for recruitment to account for up to a 20% dropout rate."}], 'paramType': 'MEAN', 'timeFrame': '1 year from the date of the manipulation', 'description': 'Knee range of motion after manipulation will be measured in degrees as the total arc of motion from maximum passive flexion to maximum passive extension.', 'unitOfMeasure': 'Degrees', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who were able to complete a follow-up at the 1-year mark and have knee range of motion measured.'}, {'type': 'SECONDARY', 'title': 'Knee Society Functional Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MUA Alone', 'description': 'Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.'}, {'id': 'OG001', 'title': 'MUA With Dexamethasone and Celecoxib', 'description': 'For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.\n\nDexamethasone: 8 mg of IV dexamethasone immediately before MUA.\n\nCelecoxib: 2 weeks per mouth of celecoxib (200 mg daily)'}], 'classes': [{'title': '6 weeks after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.7', 'spread': '22.5', 'groupId': 'OG000'}, {'value': '64.2', 'spread': '19.2', 'groupId': 'OG001'}]}]}, {'title': '1 year after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.3', 'spread': '24.9', 'groupId': 'OG000'}, {'value': '74.2', 'spread': '20.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks after the MUA, and 1 year after the MUA', 'description': 'The Knee Society Functional score was developed by the Knee Society as a method of evaluating how well a patient can use their joint. Knee function was evaluated in two categories: walking, and stair usage. Points range from 0-100. 0 = extreme problems, 100 = no problems.\n\nIn each category, points range from 0-50, where 0 = extreme problems to 50 = no problems. Total scores are 0-100 with lower scores indicating extreme knee function problems and higher scores indicating no knee function problems.', 'unitOfMeasure': 'score on a 0-100 scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who were able to complete and return KSS Functional surveys.'}, {'type': 'SECONDARY', 'title': 'Knee Society Knee Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MUA Alone', 'description': 'Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.'}, {'id': 'OG001', 'title': 'MUA With Dexamethasone and Celecoxib', 'description': 'For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.\n\nDexamethasone: 8 mg of IV dexamethasone immediately before MUA.\n\nCelecoxib: 2 weeks per mouth of celecoxib (200 mg daily)'}], 'classes': [{'title': '6 weeks after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.1', 'spread': '17.6', 'groupId': 'OG000'}, {'value': '66.8', 'spread': '16.9', 'groupId': 'OG001'}]}]}, {'title': '1 year after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.2', 'spread': '16.1', 'groupId': 'OG000'}, {'value': '68.6', 'spread': '24.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks after the MUA, and 1 year after the MUA', 'description': "The Knee Society Knee Score is method of joint evaluation developed by the Knee Society to measure the condition of a patient's knee. Knee condition was evaluated in three categories: pain, range of motion, and stability. Points range from 0-100. 0 = extreme problems, 100 = no problems.\n\nUp to 50 points for pain, 25 points for range of motion, and 25 points for stability. Deductions occur for Extension lag, flexion contracture, malalignment, and pain at rest.", 'unitOfMeasure': 'Score on a 0-100 scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who were able to complete and return the KSS survey.'}, {'type': 'SECONDARY', 'title': 'Short Form Survey 12-item Version 2 (SF-12v2): Physical Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MUA Alone', 'description': 'Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.'}, {'id': 'OG001', 'title': 'MUA With Dexamethasone and Celecoxib', 'description': 'For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.\n\nDexamethasone: 8 mg of IV dexamethasone immediately before MUA.\n\nCelecoxib: 2 weeks per mouth of celecoxib (200 mg daily)'}], 'classes': [{'title': '6 weeks after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.7', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '37.0', 'spread': '9.7', 'groupId': 'OG001'}]}]}, {'title': '1 year after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.8', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '43.3', 'spread': '10.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks after the MUA, and 1 year after the MUA', 'description': 'The SF-12v2 questionnaire uses questions selected from the longer SF-36 Health Survey to measure patient wellness and quality of life. Responses were scored using the SF12v2 New England Medical Center (NEMC) scoring algorithm which converts the raw score from the questionnaire into a t-score. The algorithm is calibrated so that an average healthy person would have a t-score of 50 points with a standard deviation of 10. Higher scores indicate better physical health.', 'unitOfMeasure': 't-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who were able to complete and return the Physical Health portion of the SF-12 survey.'}, {'type': 'SECONDARY', 'title': 'Short Form Survey 12-item Version 2 (SF-12v2): Mental Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MUA Alone', 'description': 'Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.'}, {'id': 'OG001', 'title': 'MUA With Dexamethasone and Celecoxib', 'description': 'For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.\n\nDexamethasone: 8 mg of IV dexamethasone immediately before MUA.\n\nCelecoxib: 2 weeks per mouth of celecoxib (200 mg daily)'}], 'classes': [{'title': '6 weeks after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.7', 'spread': '9.9', 'groupId': 'OG000'}, {'value': '53.7', 'spread': '9.8', 'groupId': 'OG001'}]}]}, {'title': '1 year after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.4', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '54.3', 'spread': '8.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks after MUA, 1 Year after MUA', 'description': 'The SF-12v2 questionnaire uses questions selected from the longer SF-36 Health Survey to measure patient wellness and quality of life. Responses were scored using the SF12v2 New England Medical Center (NEMC) scoring algorithm which converts the raw score from the questionnaire into a t-score. The algorithm is calibrated so that an average healthy person would have a t-score of 50 points with a standard deviation of 10. Higher scores indicate better mental health.', 'unitOfMeasure': 't-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who completed and returned the SF-12 survey.'}, {'type': 'SECONDARY', 'title': 'Knee Injury and Osteoarthritis Outcome Score (KOOS): Symptom Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MUA Alone', 'description': 'Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.'}, {'id': 'OG001', 'title': 'MUA With Dexamethasone and Celecoxib', 'description': 'For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.\n\nDexamethasone: 8 mg of IV dexamethasone immediately before MUA.\n\nCelecoxib: 2 weeks per mouth of celecoxib (200 mg daily)'}], 'classes': [{'title': '6 weeks after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.2', 'spread': '22.4', 'groupId': 'OG000'}, {'value': '58.0', 'spread': '19.9', 'groupId': 'OG001'}]}]}, {'title': '1 year after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.5', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '75.7', 'spread': '16.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks after the MUA, and 1 year after the MUA', 'description': 'The KOOS is a commonly used questionnaire which focuses on how patients are affected by osteoarthritis symptoms in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme problems, 100 = no problems.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who completed the KOOS questionnaire and returned it.'}, {'type': 'SECONDARY', 'title': 'Knee Injury and Osteoarthritis Outcome Score (KOOS): Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MUA Alone', 'description': 'Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.'}, {'id': 'OG001', 'title': 'MUA With Dexamethasone and Celecoxib', 'description': 'For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.\n\nDexamethasone: 8 mg of IV dexamethasone immediately before MUA.\n\nCelecoxib: 2 weeks per mouth of celecoxib (200 mg daily)'}], 'classes': [{'title': '6 weeks after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.9', 'spread': '20.3', 'groupId': 'OG000'}, {'value': '62.7', 'spread': '18.1', 'groupId': 'OG001'}]}]}, {'title': '1 year after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84.1', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '79.8', 'spread': '17.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks after the MUA, and 1 year after the MUA', 'description': 'The KOOS is a commonly used questionnaire which focuses on how patients are affected by osteoarthritis symptoms in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme problems, 100 = no problems.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who completed the KOOS survey and returned it.'}, {'type': 'SECONDARY', 'title': 'Knee Injury and Osteoarthritis Outcome Score (KOOS): Activities of Daily Living (ADL) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MUA Alone', 'description': 'Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.'}, {'id': 'OG001', 'title': 'MUA With Dexamethasone and Celecoxib', 'description': 'For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.\n\nDexamethasone: 8 mg of IV dexamethasone immediately before MUA.\n\nCelecoxib: 2 weeks per mouth of celecoxib (200 mg daily)'}], 'classes': [{'title': '6 weeks after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.1', 'spread': '13.7', 'groupId': 'OG000'}, {'value': '70.3', 'spread': '16.4', 'groupId': 'OG001'}]}]}, {'title': '1 year after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.0', 'spread': '18.1', 'groupId': 'OG000'}, {'value': '76.6', 'spread': '20.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks after MUA, 1 year after MUA', 'description': 'The KOOS is a commonly used questionnaire which focuses on how patients are affected by osteoarthritis symptoms in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme problems, 100 = no problems.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who completed and returned the KOOS survey.'}, {'type': 'SECONDARY', 'title': 'Knee Injury and Osteoarthritis Outcome Score (KOOS): Sport and Recreation Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MUA Alone', 'description': 'Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.'}, {'id': 'OG001', 'title': 'MUA With Dexamethasone and Celecoxib', 'description': 'For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.\n\nDexamethasone: 8 mg of IV dexamethasone immediately before MUA.\n\nCelecoxib: 2 weeks per mouth of celecoxib (200 mg daily)'}], 'classes': [{'title': '6 weeks after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.5', 'spread': '21.0', 'groupId': 'OG000'}, {'value': '52.8', 'spread': '17.7', 'groupId': 'OG001'}]}]}, {'title': '1 year after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.0', 'spread': '25.3', 'groupId': 'OG000'}, {'value': '62.2', 'spread': '19.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks after MUA, 1 year after MUA', 'description': 'The KOOS is a commonly used questionnaire which focuses on how patients are affected by osteoarthritis symptoms in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme problems, 100 = no problems.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who completed the KOOS survey and returned it.'}, {'type': 'SECONDARY', 'title': 'Knee Injury and Osteoarthritis Outcomes Score (KOOS): Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MUA Alone', 'description': 'Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.'}, {'id': 'OG001', 'title': 'MUA With Dexamethasone and Celecoxib', 'description': 'For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.\n\nDexamethasone: 8 mg of IV dexamethasone immediately before MUA.\n\nCelecoxib: 2 weeks per mouth of celecoxib (200 mg daily)'}], 'classes': [{'title': '6 weeks after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.2', 'spread': '22.2', 'groupId': 'OG000'}, {'value': '50.0', 'spread': '22.8', 'groupId': 'OG001'}]}]}, {'title': '1 year after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.0', 'spread': '12.8', 'groupId': 'OG000'}, {'value': '67.1', 'spread': '27.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks after MUA, 1 year after MUA', 'description': 'The KOOS is a commonly used questionnaire which focuses on how patients are affected by osteoarthritis symptoms in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme problems, 100 = no problems.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who completed the KOOS survey and returned it.'}, {'type': 'SECONDARY', 'title': 'Knee Injury and Osteoarthritis Outcome Score (KOOS) for Joint Replacement (JR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MUA Alone', 'description': 'Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.'}, {'id': 'OG001', 'title': 'MUA With Dexamethasone and Celecoxib', 'description': 'For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.\n\nDexamethasone: 8 mg of IV dexamethasone immediately before MUA.\n\nCelecoxib: 2 weeks per mouth of celecoxib (200 mg daily)'}], 'classes': [{'title': '6 weeks after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.9', 'spread': '17.7', 'groupId': 'OG000'}, {'value': '62.7', 'spread': '13.1', 'groupId': 'OG001'}]}]}, {'title': '1 year after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.5', 'spread': '17.0', 'groupId': 'OG000'}, {'value': '69.0', 'spread': '18.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks after the MUA, and 1 year after the MUA', 'description': 'KOOS JR is a questionnaire designed to measure outcomes for patients with knee replacements. Questions focus on knee stiffness, pain, and function for daily activities. Results are scored 0-100. 0 = extreme problems, 100 = no problems.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who completed the KOOS JR survey and returned it.'}, {'type': 'SECONDARY', 'title': 'PROMIS-29 Outcome Form: Physical Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MUA Alone', 'description': 'Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.'}, {'id': 'OG001', 'title': 'MUA With Dexamethasone and Celecoxib', 'description': 'For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.\n\nDexamethasone: 8 mg of IV dexamethasone immediately before MUA.\n\nCelecoxib: 2 weeks per mouth of celecoxib (200 mg daily)'}], 'classes': [{'title': '6 weeks after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.0', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '42.5', 'spread': '8.4', 'groupId': 'OG001'}]}]}, {'title': '1 year after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.2', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '45.2', 'spread': '10.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks after the MUA, and 1 year after the MUA', 'description': 'The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For physical function, higher scores indicate better function.\n\nPatient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.', 'unitOfMeasure': 't-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who completed the PROMIS-29 survey and returned it.'}, {'type': 'SECONDARY', 'title': 'PROMIS-29 Outcome Form: Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MUA Alone', 'description': 'Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.'}, {'id': 'OG001', 'title': 'MUA With Dexamethasone and Celecoxib', 'description': 'For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.\n\nDexamethasone: 8 mg of IV dexamethasone immediately before MUA.\n\nCelecoxib: 2 weeks per mouth of celecoxib (200 mg daily)'}], 'classes': [{'title': '6 weeks after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.3', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '48.9', 'spread': '9.4', 'groupId': 'OG001'}]}]}, {'title': '1 year after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.6', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '45.5', 'spread': '8.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks after MUA, and 1 year after MUA', 'description': 'The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For anxiety, lower scores indicate less anxiety.\n\nPatient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.', 'unitOfMeasure': 't-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who completed the PROMIS-29 survey and returned it.'}, {'type': 'SECONDARY', 'title': 'PROMIS-29 Outcome Form: Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MUA Alone', 'description': 'Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.'}, {'id': 'OG001', 'title': 'MUA With Dexamethasone and Celecoxib', 'description': 'For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.\n\nDexamethasone: 8 mg of IV dexamethasone immediately before MUA.\n\nCelecoxib: 2 weeks per mouth of celecoxib (200 mg daily)'}], 'classes': [{'title': '6 weeks after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.6', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '48.7', 'spread': '8.6', 'groupId': 'OG001'}]}]}, {'title': '1 year after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.0', 'spread': '0', 'groupId': 'OG000'}, {'value': '46.8', 'spread': '8.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks after MUA, and 1 year after MUA', 'description': 'The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For depression, lower scores indicate fewer depressive symptoms.\n\nPatient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.', 'unitOfMeasure': 't-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who completed the PROMIS-29 questionnaire and returned it.'}, {'type': 'SECONDARY', 'title': 'PROMIS-29 Outcome Form: Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MUA Alone', 'description': 'Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.'}, {'id': 'OG001', 'title': 'MUA With Dexamethasone and Celecoxib', 'description': 'For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.\n\nDexamethasone: 8 mg of IV dexamethasone immediately before MUA.\n\nCelecoxib: 2 weeks per mouth of celecoxib (200 mg daily)'}], 'classes': [{'title': '6 weeks after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.6', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '48.2', 'spread': '8.5', 'groupId': 'OG001'}]}]}, {'title': '1 year after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.3', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '41.5', 'spread': '8.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks after MUA, and 1 year after MUA', 'description': 'The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For fatigue, lower scores indicate less fatigue.\n\nPatient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.', 'unitOfMeasure': 't-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who completed the PROMIS-29 survey and returned it.'}, {'type': 'SECONDARY', 'title': 'PROMIS-29 Outcome Form: Sleep Disturbance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MUA Alone', 'description': 'Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.'}, {'id': 'OG001', 'title': 'MUA With Dexamethasone and Celecoxib', 'description': 'For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.\n\nDexamethasone: 8 mg of IV dexamethasone immediately before MUA.\n\nCelecoxib: 2 weeks per mouth of celecoxib (200 mg daily)'}], 'classes': [{'title': '6 weeks after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.7', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '57.4', 'spread': '8.6', 'groupId': 'OG001'}]}]}, {'title': '1 year after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.3', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '48.0', 'spread': '7.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks after MUA, and 1 year after MUA', 'description': 'The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For sleep disturbance, lower scores indicate less sleep disturbance.\n\nPatient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.', 'unitOfMeasure': 't-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who completed the PROMIS-29 survey and returned it.'}, {'type': 'SECONDARY', 'title': 'PROMIS-29 Outcome Form: Social Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MUA Alone', 'description': 'Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.'}, {'id': 'OG001', 'title': 'MUA With Dexamethasone and Celecoxib', 'description': 'For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.\n\nDexamethasone: 8 mg of IV dexamethasone immediately before MUA.\n\nCelecoxib: 2 weeks per mouth of celecoxib (200 mg daily)'}], 'classes': [{'title': '6 weeks after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.2', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '51.5', 'spread': '9.2', 'groupId': 'OG001'}]}]}, {'title': '1 year after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.3', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '56.1', 'spread': '10.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks after MUA, and 1 year after MUA', 'description': 'The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For social activities, higher scores indicate a better ability to participate in social roles and activities.\n\nPatient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.', 'unitOfMeasure': 't-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who completed the PROMIS-29 survey and returned it.'}, {'type': 'SECONDARY', 'title': 'PROMIS-29 Outcome Form: Pain Interference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MUA Alone', 'description': 'Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.'}, {'id': 'OG001', 'title': 'MUA With Dexamethasone and Celecoxib', 'description': 'For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.\n\nDexamethasone: 8 mg of IV dexamethasone immediately before MUA.\n\nCelecoxib: 2 weeks per mouth of celecoxib (200 mg daily)'}], 'classes': [{'title': '6 weeks after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.1', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '58.2', 'spread': '7.3', 'groupId': 'OG001'}]}]}, {'title': '1 year after MUA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.4', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '56.7', 'spread': '12.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks after MUA, 1 year after MUA', 'description': 'The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For pain interference, higher scores indicate more frequent interference in activities due to pain.\n\nPatient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.', 'unitOfMeasure': 't-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who completed the PROMIS-29 survey and returned it.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MUA Alone', 'description': 'Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.'}, {'id': 'FG001', 'title': 'MUA With Dexamethasone and Celecoxib', 'description': 'For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.\n\nDexamethasone: 8 mg of IV dexamethasone immediately before MUA.\n\nCelecoxib: 2 weeks per mouth of celecoxib (200 mg daily)'}], 'periods': [{'title': '6 Weeks Post-MUA', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}, {'title': '1 Year Post-MUA', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}], 'recruitmentDetails': 'Participants were recruited from 16 orthopedic surgery centers across the United States. Enrollment took place between 2016 and 2021. The first patient was enrolled in October of 2016 and the final patient was enrolled in November of 2021.', 'preAssignmentDetails': '441 patients were screened for eligibility, 130 of which met inclusion criteria, were enrolled in the trial and had treatment randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MUA Alone', 'description': 'Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.'}, {'id': 'BG001', 'title': 'MUA With Dexamethasone and Celecoxib', 'description': 'For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.\n\nDexamethasone: 8 mg of IV dexamethasone immediately before MUA.\n\nCelecoxib: 2 weeks per mouth of celecoxib (200 mg daily)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '61.6', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '61.8', 'spread': '8.4', 'groupId': 'BG001'}, {'value': '61.7', 'spread': '9.65', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Weight (kg)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '90.0', 'spread': '18.0', 'groupId': 'BG000'}, {'value': '88.6', 'spread': '19.6', 'groupId': 'BG001'}, {'value': '89.3', 'spread': '18.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height (cm)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '169.2', 'spread': '10.4', 'groupId': 'BG000'}, {'value': '166.6', 'spread': '11.0', 'groupId': 'BG001'}, {'value': '167.9', 'spread': '10.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI (kg/m^2)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31.4', 'spread': '5.6', 'groupId': 'BG000'}, {'value': '32.2', 'spread': '6.0', 'groupId': 'BG001'}, {'value': '31.8', 'spread': '5.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilograms per meter-squared', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'ASA Status (n, %)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}], 'categories': [{'title': 'I', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'II', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': 'III', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'IV', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The American Society of Anesthesiologists Physical Status Classification System (ASA Status) contains 6 total categories for assessing the physical health of patients.\n\nClass I: Healthy person Class II: Mild systemic disease (i.e. controlled diabetes or minor infection) Class III: Severe systemic disease ( Class IV: Life threatening systemic disease Class V: Moribund and is not expected to survive without operation Class VI: Declared brain dead, but donating organs\n\nFor the purposes of this study, only patients from classes I-IV were enrolled.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-08', 'size': 197930, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-09-27T09:56', 'hasProtocol': True}, {'date': '2022-02-04', 'size': 357255, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-09-27T09:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-02', 'studyFirstSubmitDate': '2016-03-31', 'resultsFirstSubmitDate': '2023-09-28', 'studyFirstSubmitQcDate': '2016-04-13', 'lastUpdatePostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-02', 'studyFirstPostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee Range of Motion After Manipulation Under Anesthesia', 'timeFrame': '6 weeks after manipulation', 'description': 'Knee range of motion after manipulation will be measured in degrees as the total arc of motion from maximum passive flexion to maximum passive extension.'}, {'measure': 'Knee Range of Motion After Manipulation Under Anesthesia', 'timeFrame': '1 year from the date of the manipulation', 'description': 'Knee range of motion after manipulation will be measured in degrees as the total arc of motion from maximum passive flexion to maximum passive extension.'}], 'secondaryOutcomes': [{'measure': 'Knee Society Functional Score', 'timeFrame': '6 weeks after the MUA, and 1 year after the MUA', 'description': 'The Knee Society Functional score was developed by the Knee Society as a method of evaluating how well a patient can use their joint. Knee function was evaluated in two categories: walking, and stair usage. Points range from 0-100. 0 = extreme problems, 100 = no problems.\n\nIn each category, points range from 0-50, where 0 = extreme problems to 50 = no problems. Total scores are 0-100 with lower scores indicating extreme knee function problems and higher scores indicating no knee function problems.'}, {'measure': 'Knee Society Knee Score', 'timeFrame': '6 weeks after the MUA, and 1 year after the MUA', 'description': "The Knee Society Knee Score is method of joint evaluation developed by the Knee Society to measure the condition of a patient's knee. Knee condition was evaluated in three categories: pain, range of motion, and stability. Points range from 0-100. 0 = extreme problems, 100 = no problems.\n\nUp to 50 points for pain, 25 points for range of motion, and 25 points for stability. Deductions occur for Extension lag, flexion contracture, malalignment, and pain at rest."}, {'measure': 'Short Form Survey 12-item Version 2 (SF-12v2): Physical Health', 'timeFrame': '6 weeks after the MUA, and 1 year after the MUA', 'description': 'The SF-12v2 questionnaire uses questions selected from the longer SF-36 Health Survey to measure patient wellness and quality of life. Responses were scored using the SF12v2 New England Medical Center (NEMC) scoring algorithm which converts the raw score from the questionnaire into a t-score. The algorithm is calibrated so that an average healthy person would have a t-score of 50 points with a standard deviation of 10. Higher scores indicate better physical health.'}, {'measure': 'Short Form Survey 12-item Version 2 (SF-12v2): Mental Health', 'timeFrame': '6 weeks after MUA, 1 Year after MUA', 'description': 'The SF-12v2 questionnaire uses questions selected from the longer SF-36 Health Survey to measure patient wellness and quality of life. Responses were scored using the SF12v2 New England Medical Center (NEMC) scoring algorithm which converts the raw score from the questionnaire into a t-score. The algorithm is calibrated so that an average healthy person would have a t-score of 50 points with a standard deviation of 10. Higher scores indicate better mental health.'}, {'measure': 'Knee Injury and Osteoarthritis Outcome Score (KOOS): Symptom Score', 'timeFrame': '6 weeks after the MUA, and 1 year after the MUA', 'description': 'The KOOS is a commonly used questionnaire which focuses on how patients are affected by osteoarthritis symptoms in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme problems, 100 = no problems.'}, {'measure': 'Knee Injury and Osteoarthritis Outcome Score (KOOS): Pain Score', 'timeFrame': '6 weeks after the MUA, and 1 year after the MUA', 'description': 'The KOOS is a commonly used questionnaire which focuses on how patients are affected by osteoarthritis symptoms in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme problems, 100 = no problems.'}, {'measure': 'Knee Injury and Osteoarthritis Outcome Score (KOOS): Activities of Daily Living (ADL) Score', 'timeFrame': '6 weeks after MUA, 1 year after MUA', 'description': 'The KOOS is a commonly used questionnaire which focuses on how patients are affected by osteoarthritis symptoms in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme problems, 100 = no problems.'}, {'measure': 'Knee Injury and Osteoarthritis Outcome Score (KOOS): Sport and Recreation Score', 'timeFrame': '6 weeks after MUA, 1 year after MUA', 'description': 'The KOOS is a commonly used questionnaire which focuses on how patients are affected by osteoarthritis symptoms in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme problems, 100 = no problems.'}, {'measure': 'Knee Injury and Osteoarthritis Outcomes Score (KOOS): Quality of Life', 'timeFrame': '6 weeks after MUA, 1 year after MUA', 'description': 'The KOOS is a commonly used questionnaire which focuses on how patients are affected by osteoarthritis symptoms in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme problems, 100 = no problems.'}, {'measure': 'Knee Injury and Osteoarthritis Outcome Score (KOOS) for Joint Replacement (JR)', 'timeFrame': '6 weeks after the MUA, and 1 year after the MUA', 'description': 'KOOS JR is a questionnaire designed to measure outcomes for patients with knee replacements. Questions focus on knee stiffness, pain, and function for daily activities. Results are scored 0-100. 0 = extreme problems, 100 = no problems.'}, {'measure': 'PROMIS-29 Outcome Form: Physical Function', 'timeFrame': '6 weeks after the MUA, and 1 year after the MUA', 'description': 'The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For physical function, higher scores indicate better function.\n\nPatient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.'}, {'measure': 'PROMIS-29 Outcome Form: Anxiety', 'timeFrame': '6 weeks after MUA, and 1 year after MUA', 'description': 'The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For anxiety, lower scores indicate less anxiety.\n\nPatient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.'}, {'measure': 'PROMIS-29 Outcome Form: Depression', 'timeFrame': '6 weeks after MUA, and 1 year after MUA', 'description': 'The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For depression, lower scores indicate fewer depressive symptoms.\n\nPatient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.'}, {'measure': 'PROMIS-29 Outcome Form: Fatigue', 'timeFrame': '6 weeks after MUA, and 1 year after MUA', 'description': 'The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For fatigue, lower scores indicate less fatigue.\n\nPatient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.'}, {'measure': 'PROMIS-29 Outcome Form: Sleep Disturbance', 'timeFrame': '6 weeks after MUA, and 1 year after MUA', 'description': 'The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For sleep disturbance, lower scores indicate less sleep disturbance.\n\nPatient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.'}, {'measure': 'PROMIS-29 Outcome Form: Social Activities', 'timeFrame': '6 weeks after MUA, and 1 year after MUA', 'description': 'The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For social activities, higher scores indicate a better ability to participate in social roles and activities.\n\nPatient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.'}, {'measure': 'PROMIS-29 Outcome Form: Pain Interference', 'timeFrame': '6 weeks after MUA, 1 year after MUA', 'description': 'The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For pain interference, higher scores indicate more frequent interference in activities due to pain.\n\nPatient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stiffness Following Total Knee Arthroplasty']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Compare the outcome following manipulation under anesthesia for stiffness in a randomized controlled fashion with one group receiving IV dexamethasone and oral celecoxib at the time of manipulation to a control group receiving manipulation alone.\n\nOutcomes will include pain, range of motion, as well as subjective outcome scores.', 'detailedDescription': 'Stiffness is a potential complication following Total Knee Arthroplasty (TKA). While a variety of factors have been cited as possible causes, such as component malrotation or improper soft-tissue balancing, however, an etiology is not always appreciated. Histologic and arthroscopic evidence of fibrosis suggests that an inflammatory process may contribute to loss of knee range of motion following surgery. Manipulation under anesthesia remains standard of care for stiffness following TKA. Manipulation shows improved range of motion for stiffness after total knee arthroplasty, however, patients do not always achieve full range of motion. Furthermore, repeat manipulation and manipulation greater than 8 weeks post-surgically have shown limited improvements. Given a possible role of the host inflammatory response and the importance of early gains in knee range of motion following total knee arthroplasty, limiting the inflammatory response at the time of manipulation may improve outcomes. Investigators would like to assess the role of anti-inflammatory medications to optimize range of motion and outcome for manipulation under anesthesia for stiffness following TKA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjects who have received a primary unilateral TKA for a diagnosis of osteoarthritis.\n2. MUA's scheduled between 6-10 weeks postoperatively\n\nExclusion Criteria:\n\n1. Intolerance to NSAIDs\n2. Renal dysfunction\n3. Age \\< 18 or \\> 90 years\n4. Primary diagnosis of rheumatoid arthritis\n5. Patients with a Glomerular Filtration Rate (GFR) \\<60 as the cut off for Chronic Kidney Disease (CKD) (stage 3 CKD)"}, 'identificationModule': {'nctId': 'NCT02739035', 'acronym': 'MUA', 'briefTitle': 'MUA to Treat Postoperative Stiffness After Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Manipulation Under Anesthesia (MUA) to Treat Postoperative Stiffness After Total Knee Arthroplasty: A Multicenter Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '15-009075'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'MUA alone', 'description': 'Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.'}, {'type': 'EXPERIMENTAL', 'label': 'MUA with dexamethasone and celecoxib', 'description': 'For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.', 'interventionNames': ['Drug: Dexamethasone', 'Drug: Celecoxib']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Decadron'], 'description': '8 mg of IV dexamethasone immediately before MUA.', 'armGroupLabels': ['MUA with dexamethasone and celecoxib']}, {'name': 'Celecoxib', 'type': 'DRUG', 'otherNames': ['Celebrex'], 'description': '2 weeks per mouth of celecoxib (200 mg daily)', 'armGroupLabels': ['MUA with dexamethasone and celecoxib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'HipKnee Arkansas Foundation', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '80210', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Joint Replacement', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Univ. of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Joint Diseases', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York - Presbyterian at Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'OrthoCarolina', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Ceter, Dept. of Orthopaedics', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43054', 'city': 'New Albany', 'state': 'Ohio', 'country': 'United States', 'facility': 'Joint Implant Surgeons', 'geoPoint': {'lat': 40.08117, 'lon': -82.80879}}, {'zip': '19446', 'city': 'Lansdale', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rothman Institute', 'geoPoint': {'lat': 40.2415, 'lon': -75.28379}}, {'zip': '19106', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Aria 3B Orthopaedic Specialists', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Orthopaedic Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Abdel Matthew, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Knee Society', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant - Knee Surgery', 'investigatorFullName': 'Matthew P. Abdel, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}