Second Line Treatment of Knee Osteochondral Lesion With Treated Osteochondral Graft (NCT02430558) | Clinical Trial Compass
TerminatedPhase 1/2
Second Line Treatment of Knee Osteochondral Lesion With Treated Osteochondral Graft
Stopped: Low accrual rate
10 participantsStarted 2016-04-05
Plain-language summary
Patient with IKDC score \< 65, pretreated with mosaicplasty or ACI ( with matrix or not) within \> 18 months, with one or two osteochondral lesions are recruited to have treated osteochondral allografts in mosaicplasty.
Who can participate
Age range18 Years – 55 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:
* Male and female patients between the ages of 18 and 55
* osteochondral lesions of the knee due to trauma or osteochondritis dissecans or removal treatment ( lesion post autograft)
* Osteochondral lesion \> grade II- ICRS
* One lesion or 2 concomitant lesions (tibial plateau, patella and condyles )at least one lesion has been pretreated by mosaicplasy or ACI. These treatment would have to have been made at least 18 months before inclusion
* Presence of disabling and clinically meaningful symptoms (subjective IKDC \< 65, no improvement for 3 months)
* No significant obesity (BMI \< 30)
* Accompanying ligamentous and meniscal lesions, joint malalignment and patella femoral instability are authorized and corrected concurrently.
* Patient able to understand, sign and date the informed consent form
* Patient affiliated with a national health insurance system or who is the beneficiary of such as system
* Women of childbearing age may not be included in the clinical trial unless their pregnancy test is negative. If this test is negative, they will be asked to use an effective birth control method during the entire the study.
Exclusion Criteria:
* \- Pregnant or breast feeding women: Women of childbearing age will be asked to undergo a pregnancy test before being enrolled into the study and to use an effective birth control method.
* Presence of osteoarthritis, rheumatoid arthritis, any other condition of knee joint that, in the surgeon's op…