Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-02-12 @ 2:20 PM
Study NCT ID:
NCT02912351
Status:
COMPLETED
Last Update Posted:
2022-04-01
First Post:
2016-01-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Post-Market Retrospective Study on Revision Total Knee Arthroplasty Using Medacta GMK® Revision Prosthesis
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014965', 'term': 'X-Rays'}], 'ancestors': [{'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-30', 'studyFirstSubmitDate': '2016-01-04', 'studyFirstSubmitQcDate': '2016-09-20', 'lastUpdatePostDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Knee Society Scores (KSS)', 'timeFrame': 'Minimum 2 years post surgery', 'description': 'Total Knee Society Score questionnaire to assess Patient satisfaction and Patient expectations and objective knee scores.'}], 'secondaryOutcomes': [{'measure': 'Radiographic Analysis', 'timeFrame': 'Minimum 2 years post surgery', 'description': 'Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration and the presence and progression of radiolucent line between the prosthesis, bone and cement.'}, {'measure': 'Patient Satisfaction', 'timeFrame': 'Minimum 2 years post surgery', 'description': 'Assessed with a Likert scale questionnaire for satisfaction of treatment outcome.'}, {'measure': 'Complication Assessment', 'timeFrame': 'minimum 2 years post surgery', 'description': 'by reviewing Adverse Events'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Total Knee Arthroplasty', 'Total Knee Replacement', 'Revision Knee Arthroplasty'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'This is a retrospective, single-site observational study, designed to assess the clinical outcomes and collect safety data of GMK Revision knee system used for primary or revision total knee arthroplasty at minimum two years post-treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'For patients that had received the treatment modality, GMK Revision Knee System and are at least 2 years (24 months) out from surgery.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to any study procedure.\n* Patients with ability to understand and provide written authorization for use and disclosure of personal health information\n* Patients must be willing to comply with the post-operative evaluation schedule.\n* Patients underwent either a primary or revision total knee replacement for any type of etiology (Osteoarthritis, Avascular necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis, Polyarthritis, Primary implantation failure).\n* Patients must have received a GMK Revision component\n* Patients must be at minimum 2 year (24 months) post-treatment\n* The operation was performed or supervised by the investigator.\n* No age limit criteria\n\nExclusion Criteria:\n\n* History of alcoholism\n* Currently on chemotherapy or radiation therapy\n* Habitual use of narcotic pain medications prior to surgery or after surgery for reasons other than knee pain\n* History of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis\n* History of chronic pain issues for reasons other than knee pain\n* Women that are pregnant'}, 'identificationModule': {'nctId': 'NCT02912351', 'briefTitle': 'A Post-Market Retrospective Study on Revision Total Knee Arthroplasty Using Medacta GMK® Revision Prosthesis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medacta USA'}, 'officialTitle': 'A Post-Market, Single-Center, Retrospective Study to Collect Clinical Outcomes and Safety Data From Patients Who Have Undergone Revision Total Knee Arthroplasty Using Medacta GMK® Revision Prosthesis and Are at Least 2 Years Past Surgery', 'orgStudyIdInfo': {'id': 'K102437-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Patient record review, Radiographs, and questionaires.', 'type': 'OTHER', 'description': 'KSS-Objective Knee Scores, KSS Subsets, Radiographs and Patient Satisfaction'}]}, 'contactsLocationsModule': {'locations': [{'zip': '83706', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Saint Alphonsus Medical Group', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}], 'overallOfficials': [{'name': 'Mukesh Ahuja, MBBS, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medacta USA, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medacta USA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}