Evaluating Cryopreserved Osteochondral Allograft Cores for the Treatment of Osteochondral Lesions… (NCT06216756) | Clinical Trial Compass
RecruitingNot Applicable
Evaluating Cryopreserved Osteochondral Allograft Cores for the Treatment of Osteochondral Lesions in the Knee
United States68 participantsStarted 2024-12-01
Plain-language summary
The primary objective of this study is to obtain evidence of the effectiveness of Cryopreserved Osteochondral Allograft Core in the treatment of osteochondral lesions on the femoral condyle.
Who can participate
Age range12 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients are ≥12 years and ≤ 60 years of age at the time of surgery.
* Symptomatic patient presenting with moderate to severe pain in the index knee - unresponsive to conservative treatment (i.e., medication, bracing, physical therapy) and/or previous surgical intervention OR unsalvageable lesion that requires transplantation at the discretion of the treating physician.
* Radiographically diagnosed, by MRI or CT scans, or through arthroscopy, to have a cartilage defect on the femoral condyle between 0.9-8.0 cm2 in size.
* Will be having an osteochondral transplant procedure.
* Has a mechanically stable knee or can be mechanically stabilized in the same procedure.
* Has a normally aligned knee as confirmed by anatomic comparison to contralateral limb, or \<5° varus or valgus malalignment that has been corrected or will be corrected in same procedure.
* Ipsilateral knee compartment has intact menisci or requires partial meniscectomy ≤ 50% resulting in stable menisci.
* Confirmation MRI, CT scan, or arthroscopy obtained pre-operatively within 90 days of surgery
* Willingness to follow standardized rehabilitation procedures.
* Has the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.
Exclusion Criteria:
* Bipolar articular cartilage involvement (kissing lesions) of the ipsilateral compartment (i.e., \> than ICRS Grade 2 on the opposing articular surface).
* Has had a prior oste…
What they're measuring
1
International Knee Documentation Committee (IKDC) score