WithdrawnNot Applicable

Long Term Outcomes of Osteochondral Allografts for Osteochondral Defects of the Knee

Stopped: New study initiated to replace this one

United States0Started 2014-05

Plain-language 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 such grafts, and to compare the overall outcomes of the grafts to the current standard of care for smaller lesions, microfracture. Our hypothesis is that patients treated with these allografts will demonstrate significant functional improvement as measured by validated outcome scoring measures and their function will be at least equal to that of microfracture outcomes.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

What they're measuring

Pain Level

Timeframe: 1 Year

Activity Level

Timeframe: 1 Year

Trial details

NCT IDNCT02308358

SponsorUniversity of Missouri-Columbia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2015-07

View on ClinicalTrials.gov More Outcomes of Allograft trials