Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2026-04-27 @ 4:25 PM
Study NCT ID:
NCT02079493
Status:
TERMINATED
Last Update Posted:
2019-08-28
First Post:
2014-02-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Functional Outcome Study of the Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019645', 'term': 'Arthroplasty, Replacement, Knee'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Not enough subject enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-27', 'studyFirstSubmitDate': '2014-02-24', 'studyFirstSubmitQcDate': '2014-03-03', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional testing', 'timeFrame': '6 weeks post-op', 'description': 'Assess patient functional outcomes'}, {'measure': 'Functional testing', 'timeFrame': '6 months post-op', 'description': 'Assess patient functional outcomes'}, {'measure': 'Functional testing', 'timeFrame': '1-year post-op', 'description': 'Assess patient functional outcomes'}], 'secondaryOutcomes': [{'measure': 'Outcome questionnaires', 'timeFrame': '6-weeks post-op', 'description': 'to assess knee pain and function'}, {'measure': 'Outcome questionnaires', 'timeFrame': '6-months post-op', 'description': 'to assess knee pain and function'}, {'measure': 'outcome questionnaires', 'timeFrame': '1-year post-op', 'description': 'to assess knee pain and function'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['osteoarthritis', 'knee replacement', 'functional testing'], 'conditions': ['Osteoarthritis of the Knee']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to obtain patient-oriented and clinically-oriented physical function outcomes both pre-operatively and post-operatively in patients receiving a total knee arthroplasty .', 'detailedDescription': "This study aims to use up to 75 patients at 3 centers to determine a baseline short-term postoperative physical function status of patients undergoing a total knee arthroplasty through patient and clinically based assessments. The KOOS score will collect data on the patient's physical function, stiffness, and pain. The BERG balance, TUG, and TUDS tests will be used quantitatively to assess the patient's ability to conduct activities of daily living like walking for an extended period of time, standing from a seated position, and maintaining balance while performing a series of actions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Total knee arthroplasty patients', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient is a male or non-pregnant female age 18 years or older at time of study\n* Patient is a candidate for a total knee arthroplasty\n* Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.\n\nExclusion Criteria:\n\n* Patients younger than 18 years of age\n* Patients with a primary diagnosis other than osteoarthritis of the knee as determined by an orthopaedic surgeon\n* Patients who have had any previous lower extremity procedure\n* Patients with a BMI greater than or equal to 40\n* Patients with an active infection within the affected knee joint Patients with a neuromuscular or neurosensory deficiency that may limit the ability of the patient to evaluate the safety and efficacy of the device\n* Patient is diagnosed with systemic disease or metabolic disorder leading to progressive bone deterioration (e.g. Lupus Erythematosus, Paget's Disease)\n* Patient is immunologically suppressed or receiving chronic steroids in excess of normal physiological requirements (e.g. greater than 30 days)\n* Patient has a known sensitivity to device materials\n* Non-English speaking patients\n* Patient is a prisoner"}, 'identificationModule': {'nctId': 'NCT02079493', 'acronym': 'PFOSK', 'briefTitle': 'Prospective Functional Outcome Study of the Knee', 'organization': {'class': 'OTHER', 'fullName': 'Tufts Medical Center'}, 'officialTitle': 'Prospective Functional Outcome Study of the Knee', 'orgStudyIdInfo': {'id': '11109-Conformis'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Total Knee Arthroplasty patients', 'description': 'TKA patients', 'interventionNames': ['Device: Total Knee Arthroplasty']}], 'interventions': [{'name': 'Total Knee Arthroplasty', 'type': 'DEVICE', 'otherNames': ['ConforMIS, Off the shelf, TKA'], 'description': 'Knee replacement', 'armGroupLabels': ['Total Knee Arthroplasty patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Eric L Smith, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to PI moving locations and site closing out study, not all follow-up data will be collected and results will not be analyzed'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Restor3D', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}