Ignite Creation Date:
2025-12-24 @ 12:39 PM
Ignite Modification Date:
2025-12-29 @ 2:05 AM
Study NCT ID:
NCT04709861
Status:
TERMINATED
Last Update Posted:
2024-04-24
First Post:
2020-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TAR 2 Weeks vs 6 Weeks Post-Operative Weight-Bearing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'PI left the institution before enrollment was completed', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-22', 'studyFirstSubmitDate': '2020-12-18', 'studyFirstSubmitQcDate': '2021-01-13', 'lastUpdatePostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'osseointegration', 'timeFrame': 'time of surgery through 2 years', 'description': 'a Chi Square Test will take place during the post-operative care period and will be conducted as part of their post-operative care by the operating physician.'}], 'secondaryOutcomes': [{'measure': 'stability of implant', 'timeFrame': 'time of surgery through 2 years', 'description': 'radiological images assessment will take place during the post-operative care period and will be conducted as part of their post-operative care by the operating physician.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ankle Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The Investigators hypothesize that an early 2 week post-operative protocol will have no difference in the successful osseointegration and stability of the total ankle replacement as compared to a delayed 6 week post-operative protocol. The importance of the research is to allow patients who receive a total ankle replacement to bear weight 4 weeks earlier than the current protocol with no negative effect on the osseointegration and stability of the ankle replacement.', 'detailedDescription': 'The study will be conducted using two groups. The first group will be a retrospective review of charts of 35 patients who received a total ankle replacement porous prosthesis by an orthopedic surgeon at the University of Oklahoma Health Sciences Center. This group was received a delayed 6 week post-operative weight-bearing protocol.\n\nThe second group will be prospective and include patients who will receive the same total ankle replacement porous prosthesis but will be assigned to early 2 weeks post-operative weight-bearing protocol.The retrospective and prospective groups will be age and gender matched. A Wright Medical Infinity Total Ankle Replacement System will be used for both groups.\n\nBoth groups will be assessed at 1 year and 2 years post-operative. This assessment will take place during the post-operative care period and will be conducted as part of their post-operative care by the operating physician.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '35', 'healthyVolunteers': True, 'eligibilityCriteria': 'Retrospective/Prospective Inclusion Criteria:\n\nPatients who have had a total ankle replacement with the Principal Investigator from the initiation of his clinical practice from September 2015 to September 2020.\n\nHad delayed weight-bearing. Patients whose age and gender match the retrospective delayed weight-bearing group.\n\nRetrospective/Prospective Exclusion Criteria:\n\nPatients who have had Total Ankle Replacement with subsequent development of suture wound infection.\n\nPatients who have had Total Ankle Replacement with subsequent development of deep infection requiring revision.\n\nPatient who have had Total Ankle Replacement with subsequent development of Peri-prosthetic fractures during surgery or post-op.'}, 'identificationModule': {'nctId': 'NCT04709861', 'acronym': 'TAR', 'briefTitle': 'TAR 2 Weeks vs 6 Weeks Post-Operative Weight-Bearing', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Early 2 Weeks Versus Delayed 6 Weeks Post-Operative Weight-Bearing in Total Ankle Replacement', 'orgStudyIdInfo': {'id': '12704'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retrospective 6 week Weight-Bearing', 'description': 'Delayed weight-bearing 6 weeks after total ankle replacement'}, {'label': 'Prospective 2 week Weight-Bearing', 'description': 'Early weight-bearing 2 weeks after total ankle replacement'}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'OUPhysicians', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Amgaad Haleem, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma, Orthopedic Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Information will only be shared with the our own research team'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}