Status:
WITHDRAWN
Long Term Outcomes of Osteochondral Allografts for Osteochondral Defects of the Knee
Lead Sponsor:
University of Missouri-Columbia
Conditions:
Outcomes of Allograft
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to evaluate the functional and clinical outcomes of patients receiving femoral condyle osteochondral allografts, to evaluate potential predisposing factors to failure of s...
Detailed Description
Localized articular cartilage defects are a common and challenging problem, particularly in young patients. These defects cause significant disability and, as participation in sports activity grows, a...
Eligibility Criteria
Inclusion
- Adults age ≥18 years
- Femoral condyle osteochondral defect ≥10mm as determined by MRI or diagnostic knee arthroscopy for allograft transplantation, defect \<10mm for microfracture treatment
- Must be physically and mentally willing and able to comply with postoperative and routinely scheduled clinical and radiographic evaluations.
- Must be able and willing to follow a standardized rehabilitation protocol.
- Must be able to read and understand English or a language for which translated versions of the patient reported questionnaires and Informed consent form are available.
- Must be able to sign informed consent and must voluntarily sign the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved subject Informed Consent Form.
Exclusion
- 1\. Presence of ipsilateral articular fractures, knee ligament injuries or extensor mechanism injuries
- 2\. Presence of severe soft tissue injuries around the knee that have required or may require skin grafting or flap coverage.
- 3\. Presence of a previous below knee amputation
- 4\. Presence of inflammatory systemic arthritis or disease involving the index joint (i.e. gout)
- 5\. Is a prisoner
- 6\. Is receiving workman's compensation
- 8\. Subject is mentally incompetent such that would preclude the subject from providing adequate consent and/or complying with study requirements
- 9\. Based on a clinical history, physical examination and/or subject presentation, subject has, or is suspected to have, a history of alcohol and/or drug abuse that would preclude subject from providing adequate consent and/or complying with study requirements
Key Trial Info
Start Date :
May 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02308358
Start Date
May 1 2014
End Date
July 1 2015
Last Update
August 30 2023
Active Locations (1)
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1
University of Missouri-Hospital and Clinics
Columbia, Missouri, United States, 65212