Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2026-01-03 @ 7:54 PM
Study NCT ID:
NCT02820766
Status:
TERMINATED
Last Update Posted:
2017-08-10
First Post:
2016-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Logistics of study did not allow for consistent data collection', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-08', 'studyFirstSubmitDate': '2016-06-29', 'studyFirstSubmitQcDate': '2016-06-29', 'lastUpdatePostDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in Knee Range of Motion (ROM) at the first outpatient Physical Therapy (PT) visit (≤7 days of surgery) between the 2 treatment groups', 'timeFrame': '≤7 days of surgery', 'description': 'The absolute Range of Motion of index knee will be compared between groups'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Posterior Stabilized Knee', 'Total Knee Arthroscopy', 'Journey II BCS'], 'conditions': ['Osteoarthritis', 'Degenerative Arthritis', 'Traumatic Arthritis']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to determine how the short-term outcome of subjects implanted with the JOURNEY™ II BCS Total Knee System compares to subjects implanted with other PS total knee systems, and to determine if there is a difference in health care resources consumed that may result in economic savings to patients, the facility and/or the payer.\n\nTo address the study objectives, patient self-assessment questionnaires, and other objective measures of post-operative function and health care resource utilization will be used for data collection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who have a primary diagnosis of osteoarthritis, degenerative arthritis, or traumatic arthritis and who will receive either the Journey II BCS knee or any other posterior stabilized knee.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergone unilateral primary total knee replacement with a JOURNEY™ II BCS Total Knee System or other Non-Smith \\& Nephew Posterior Stabilized Knee System\n* Will be initiating outpatient PT ≤ 7 days post-operatively\n* Has a primary diagnosis of osteoarthritis, degenerative arthritis, or traumatic arthritis\n* Has pre-operative ROM ≥ 90°\n* Is skeletally mature in the PI judgment\n* Is 21 years of age of older\n* Is willing and able to participate in required follow-up visits at the study site and to complete study procedures and questionnaires\n* Has consented to participate in the study by signing the IRB/EC approved informed consent for the study\n* Agrees to follow post- operative physical therapy program\n\nExclusion Criteria:\n\n* Significant preoperative varus or valgus deformities (\\>15º)\n* Has received a constrained or deep dish tibial insert\n* Morbid obesity (BMI \\> 40)\n* Has not obtained required pre-rehabilitation, pre-operative and intra-operative records by week 2 visit\n* Other comorbidities that may impact outcomes such as osteoporosis, uncontrolled diabetes and active infection\n* Fibromyalgia requiring treatment\n* Current or impending incarceration or is a prisoner\n* In the opinion of the PI has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse\n* Is known to be at risk for lost to follow-up, or failure to return for scheduled visits\n* Undergone or is planning to undergo total knee replacement of the contralateral knee within 6 months of this total knee replacement\n* Requires a Legally Authorized Representative to consent to the study'}, 'identificationModule': {'nctId': 'NCT02820766', 'briefTitle': 'Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting', 'organization': {'class': 'INDUSTRY', 'fullName': 'Smith & Nephew, Inc.'}, 'officialTitle': 'A Non-Randomized, Prospective Study of Short Term Outcomes Following Total Knee Replacement With JOURNEY™ II BCS Total Knee System Compared to Other Posterior Stabilized Total Knee Systems in a Physical Therapy Setting', 'orgStudyIdInfo': {'id': 'Journey II BCS CMS Study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Journey II BCS Knee', 'description': 'Physical Therapy Observational'}, {'label': 'All Other Posterior Stabilized Knees', 'description': 'Physical Therapy Observational'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21401', 'city': 'Annapolis', 'state': 'Maryland', 'country': 'United States', 'facility': 'Anne Arundel Medical Cneter', 'geoPoint': {'lat': 38.97859, 'lon': -76.49184}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Slocum Research & Educational Foundation', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '16801', 'city': 'State College', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University Orthopaedic Center', 'geoPoint': {'lat': 40.79339, 'lon': -77.86}}], 'overallOfficials': [{'name': 'Beate Hanson, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Smith & Nephew, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Study terminated therefore no data sharing planned'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Smith & Nephew, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}