Evaluation of the CR Plug (Allograft) for the Treatment of a Cartilage Injury in the Knee. (NCT00793104) | Clinical Trial Compass
TerminatedPhase 3
Evaluation of the CR Plug (Allograft) for the Treatment of a Cartilage Injury in the Knee.
Stopped: Slow enrolment \& potential regulatory changes for allograft in cartilage repair
United States10 participantsStarted 2008-11
Plain-language summary
Determine the ability of the allograft plug for the treatment of a cartilage injury in the knee
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:
* 18 years of age or older
* Skeletally mature
* Have one symptomatic score International Cartilage Repair Score (ICRS) grade 3a, 3b, 3c, 3d, 4a, 4b articular cartilage lesion less than 2.5 cm involving the Medial Femoral Condyle (MFC) or Lateral Femoral Condyle (LFC). Symptoms must include pain, pain with weight bearing and squatting, locking of joints, and/or swelling
* Functional meniscal tissue (defined as 5 mm or more width)
* A score of = or greater than 4 on the VAS questionnaire
Exclusion Criteria:
* Associated tibial or patellar articular cartilage defect greater than 2 ICRS
* Osteoarthritis of either knee
* Mechanical axis malalignment of greater than 5 degrees
* Patellofemoral incongruity of Merchant view
* One or more multiple defects greater than 2.5 cm
* Osteochondritis dissecans (OCD) with depth of bone loss greater than 4 mm
* Ligament treatments in the affected knee within one yer prior to current study
* Previous surgical meniscus treatments in the affected knee in the last 6 months
* Less than 5 mm of meniscal tissue in ipsilateral compartment of study treatment
* Use of any investigational therapy with in 30 days prior to the first visit
* Corticosteroid or viscosupplementation within the past 3 months
* A score of 3 or less on the VAS Questionnaire
* Active gout or pseudogout or systemic inflammatory condition
What they're measuring
1
The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 24 Months