Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-02 @ 1:37 PM
Study NCT ID:
NCT03153956
Status:
TERMINATED
Last Update Posted:
2020-03-24
First Post:
2017-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of AposTherapy® in Knee OA
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Dennis.Cardone@nyulangone.org', 'phone': '+1 646 501 7223', 'title': 'Dennis A. Cardone, DO', 'organization': 'NYU Langone Health'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Active Treatment Arm', 'description': 'Personally calibrated bio-mechanical device\n\nCalibrated AposTherapy®: a biomechanical device including 2 hemispheric biomechanical elements attached to a platform in a form of a shoe. the biomechanical device is calibrated to each patient by a physiotherapist specialized with the treatment methodology.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Arm', 'description': 'sham-placebo device (similar shoes without bio-mechanical elements).\n\nNon-Calibrated Sham Apos Therapy Device: The comparator group will receive a non-calibrated sham device.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Western Ontario and McMaster University (WOMAC) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment Arm', 'description': 'Personally calibrated bio-mechanical device\n\nCalibrated AposTherapy®: a biomechanical device including 2 hemispheric biomechanical elements attached to a platform in a form of a shoe. the biomechanical device is calibrated to each patient by a physiotherapist specialized with the treatment methodology.'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'sham-placebo device (similar shoes without bio-mechanical elements).\n\nNon-Calibrated Sham Apos Therapy Device: The comparator group will receive a non-calibrated sham device.'}], 'classes': [{'title': 'WOMAC Total score - screen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1062.7', 'spread': '545.96', 'groupId': 'OG000'}, {'value': '975.1', 'spread': '580.87', 'groupId': 'OG001'}]}]}, {'title': 'WOMAC Total score - 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '548.8', 'spread': '440.22', 'groupId': 'OG000'}, {'value': '601.1', 'spread': '467.39', 'groupId': 'OG001'}]}]}, {'title': 'WOMAC Total Score - 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '420.2', 'spread': '391.7', 'groupId': 'OG000'}, {'value': '524.8', 'spread': '448.83', 'groupId': 'OG001'}]}]}, {'title': 'WOMAC Total Score - 9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '280.2', 'spread': '194.84', 'groupId': 'OG001'}]}]}, {'title': 'WOMAC Total Score - 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '396.5', 'spread': '324.99', 'groupId': 'OG000'}, {'value': '433', 'spread': '352.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'screening, 3 months, 6 months, 9 months, and 12 months', 'description': 'WOMAC evaluates the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. In this study, WOMAC scores were recomputed as the sum within sub-scales (pain score is the sum of questions 1-5; stiffness is the sum of questions 6-7; functional score is the sum of questions 8-24). The total score is reported as the sum of the pain, stiffness, and functional sub-scores for all participants. The total score range is 0-1292. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who scheduled visits beyond 4 days before or after the specified timeframes (3, 6, and 9 months from screening) were not included in the analysis. (Treatment participants did not have a 9 month visit)'}, {'type': 'SECONDARY', 'title': 'Visual Analog Score (VAS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment Arm', 'description': 'Personally calibrated bio-mechanical device\n\nCalibrated AposTherapy®: a biomechanical device including 2 hemispheric biomechanical elements attached to a platform in a form of a shoe. the biomechanical device is calibrated to each patient by a physiotherapist specialized with the treatment methodology.'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'sham-placebo device (similar shoes without bio-mechanical elements).\n\nNon-Calibrated Sham Apos Therapy Device: The comparator group will receive a non-calibrated sham device.'}], 'timeFrame': '12 Months', 'description': 'The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected for this outcome measure due to study termination.'}, {'type': 'SECONDARY', 'title': 'Short-Form 36 (SF-36) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment Arm', 'description': 'Personally calibrated bio-mechanical device\n\nCalibrated AposTherapy®: a biomechanical device including 2 hemispheric biomechanical elements attached to a platform in a form of a shoe. the biomechanical device is calibrated to each patient by a physiotherapist specialized with the treatment methodology.'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'sham-placebo device (similar shoes without bio-mechanical elements).\n\nNon-Calibrated Sham Apos Therapy Device: The comparator group will receive a non-calibrated sham device.'}], 'classes': [{'title': 'SF-36 total score - screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.6', 'spread': '15.03', 'groupId': 'OG000'}, {'value': '56.6', 'spread': '16.77', 'groupId': 'OG001'}]}]}, {'title': 'SF-36 total score - 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.6', 'spread': '16.8', 'groupId': 'OG000'}, {'value': '63.0', 'spread': '17.09', 'groupId': 'OG001'}]}]}, {'title': 'SF-36 total score - 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.7', 'spread': '14.8', 'groupId': 'OG000'}, {'value': '68', 'spread': '17.21', 'groupId': 'OG001'}]}]}, {'title': 'SF-36 total score - 9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.5', 'spread': '6.37', 'groupId': 'OG001'}]}]}, {'title': 'SF-36 total score - 12 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71', 'spread': '9.77', 'groupId': 'OG000'}, {'value': '66.6', 'spread': '15.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'screening, 3 months, 6 months, 9 months, and 12 months', 'description': 'The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The survey consists eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0-100, with lower scores = more disability and higher scores = less disability. Therefore, higher scores represent better health.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who scheduled visits beyond 4 days before or after the specified timeframes (3, 6, and 9 months from screening) were not included in the analysis. (Treatment participants did not have a 9 month visit)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Treatment Arm', 'description': 'Personally calibrated bio-mechanical device\n\nCalibrated AposTherapy®: a biomechanical device including 2 hemispheric biomechanical elements attached to a platform in a form of a shoe. the biomechanical device is calibrated to each patient by a physiotherapist specialized with the treatment methodology.'}, {'id': 'FG001', 'title': 'Control Arm', 'description': 'sham-placebo device (similar shoes without bio-mechanical elements).\n\nNon-Calibrated Sham Apos Therapy Device: The comparator group will receive a non-calibrated sham device.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Treatment Arm', 'description': 'Personally calibrated bio-mechanical device\n\nCalibrated AposTherapy®: a biomechanical device including 2 hemispheric biomechanical elements attached to a platform in a form of a shoe. the biomechanical device is calibrated to each patient by a physiotherapist specialized with the treatment methodology.'}, {'id': 'BG001', 'title': 'Control Arm', 'description': 'sham-placebo device (similar shoes without bio-mechanical elements).\n\nNon-Calibrated Sham Apos Therapy Device: The comparator group will receive a non-calibrated sham device.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '62', 'spread': '9', 'groupId': 'BG000'}, {'value': '61', 'spread': '8.2', 'groupId': 'BG001'}, {'value': '61', 'spread': '8.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', '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.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-06-23', 'size': 911577, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-02-21T12:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Phase I - A prospective, interventional, randomized, double-arm clinical evaluation of patients who have been diagnosed with OA of the knee. The active treatment arm (personally calibrated biomechanical device) will be compared to a control arm (sham-placebo device) (similar shoes without biomechanical elements).\n\nPhase II - Open-label, cross-over study design. After the completion of phase one patients will be un-blinded to their group allocation. Patients that were allocated to the sham-placebo control group will cross to the active group and will receive the AposTherapy treatment. Patients that were allocated to the active group will continue with treatment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'whyStopped': 'Halt in funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-23', 'studyFirstSubmitDate': '2017-05-09', 'resultsFirstSubmitDate': '2020-02-21', 'studyFirstSubmitQcDate': '2017-05-12', 'lastUpdatePostDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-23', 'studyFirstPostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Western Ontario and McMaster University (WOMAC) Total Score', 'timeFrame': 'screening, 3 months, 6 months, 9 months, and 12 months', 'description': 'WOMAC evaluates the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. In this study, WOMAC scores were recomputed as the sum within sub-scales (pain score is the sum of questions 1-5; stiffness is the sum of questions 6-7; functional score is the sum of questions 8-24). The total score is reported as the sum of the pain, stiffness, and functional sub-scores for all participants. The total score range is 0-1292. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Score (VAS) Score', 'timeFrame': '12 Months', 'description': 'The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.'}, {'measure': 'Short-Form 36 (SF-36) Total Score', 'timeFrame': 'screening, 3 months, 6 months, 9 months, and 12 months', 'description': 'The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The survey consists eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0-100, with lower scores = more disability and higher scores = less disability. Therefore, higher scores represent better health.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['AposTherapy® System', 'Osteoarthritis', 'Total knee arthroplasties', 'Degenerative joint disease'], 'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'A prospective, interventional, randomized, double-arm clinical evaluation study to examine the efficacy of AposTherapy® versus a control group, in the short-term at 6 months and in the long-term at 12 months post-treatment, with the primary efficacy assessment based on improvement in knee pain score and improvement in function in patients following diagnosis of knee osteoarthritis (OA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering from symptomatic unilateral or bilateral knee OA at the medial compartment for at least six months;\n* Fulfilling the ACR clinical criteria;\n* Having radiographically assessed OA of the knee with a Kellgren-Lawrence grade more than or equal to grade 2; and,\n* Having VAS-Pain ≥ 3, on a scale between 0-10.\n* Patients who have a shoe size between US 4 and US 12\n\nExclusion Criteria:\n\n* Patients suffering from acute septic arthritis.\n* Patients who received a corticosteroid injection within 3 months of the study.\n* Patients who received hyaluronic acid (HA) injections within 6 months of the study\n* Patients suffering from avascular necrosis of the knee.\n* Patients with a history of knee buckling or recent knee injury.\n* Patients who have had a joint replacement or other major surgery to the knee, hip or ankle (ipsilateral or contralateral side).\n* Patients suffering from neuropathic arthropathy.\n* Patients with an increased tendency to fall.\n* Patients exhibiting a lack of physical or mental ability to perform or comply with the study procedure.\n* Patients with a history of pathological osteoporotic fracture.\n* Patients suffering from symptomatic degenerative arthritis in lower limb joints other than the knees.\n* Patients with referred pain in the knees from primary back or hip joint pain.\n* Patients with neurological deficits to the lower extremity (ex. foot drop)\n* Patients whose shoe size is less than US 4 and greater than US 12\n* Patients who have had arthroscopy within 6 months of the study\n* Patients with inflammatory arthropathy'}, 'identificationModule': {'nctId': 'NCT03153956', 'briefTitle': 'Efficacy of AposTherapy® in Knee OA', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'A Prospective, Randomized Double-Armed Efficacy Evaluation of AposTherapy® for the Treatment of Knee Osteoarthritis', 'orgStudyIdInfo': {'id': '14-02127'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Treatment Arm', 'description': 'Personally calibrated bio-mechanical device', 'interventionNames': ['Device: Calibrated AposTherapy®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Arm', 'description': 'sham-placebo device (similar shoes without bio-mechanical elements).', 'interventionNames': ['Device: Non-Calibrated Sham Apos Therapy Device']}], 'interventions': [{'name': 'Calibrated AposTherapy®', 'type': 'DEVICE', 'description': 'a biomechanical device including 2 hemispheric biomechanical elements attached to a platform in a form of a shoe. the biomechanical device is calibrated to each patient by a physiotherapist specialized with the treatment methodology.', 'armGroupLabels': ['Active Treatment Arm']}, {'name': 'Non-Calibrated Sham Apos Therapy Device', 'type': 'DEVICE', 'description': 'The comparator group will receive a non-calibrated sham device.', 'armGroupLabels': ['Control Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Dennis Cardone, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}