Chondrofix Osteochondral Allograft Prospective Study (NCT01410136) | Clinical Trial Compass
TerminatedNot Applicable
Chondrofix Osteochondral Allograft Prospective Study
Stopped: Inadequate enrollment and decreased need for clinical data to support product
United States29 participantsStarted 2011-04
Plain-language summary
The overall study objective is to evaluate Chondrofix Osteochondral Allograft ("Chondrofix") for the repair of osteochondral lesions in the knee. This includes, but is not limited to primary cartilage lesion repair and revision of failed prior cartilage repair treatments. The study hypothesis is that Chondrofix Allograft will provide pain relief and functional improvement as demonstrated by a comparative analysis of baseline clinical evaluations at 24 months of follow-up.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
Generally, the following inclusion criteria must be met, however, this is not a complete list.
* Male and non-pregnant female subjects between 18 and 70 years; subject must be skeletally mature
* If female, subjects are not pregnant at time of surgery and do not plan on becoming pregnant during the first 24 months of the study
* Up to two (2) cartilage lesion(s), each measuring less than 8 cm2, of the femoral condyle or trochlear groove of the knee
* Localized knee pain unresponsive to conservative treatment (e.g., medication, bracing, physical therapy) and/or previous surgical intervention
Exclusion Criteria:
Generally, if a potential participant meets any of the following criteria, they will not be eligible for this study. Additionally, more criteria will be evaluated to confirm eligibility as this list is not a complete list of criteria.
* Concurrent participation in another clinical trial
* Cartilage lesion location is such that the implanted graft(s) will not be adequately shouldered
* Bipolar articular cartilage involvement (or kissing lesions) of the ipsilateral compartment (i.e., \> than ICRS Grade 2 on the opposing articular surface)
* Is receiving pain medication other than NSAIDs or acetaminophen for conditions unrelated to the index knee condition
* Subject had any other cartilage repair procedure other than debridement performed in conjunction with or 6 months prior to implantation of a Chondrofix Osteochondral Allograft
* Prior or concur…