Evaluation of the CR Plug (Allograft) for the Treatment of a Cartilage Injury in the Knee.
Stopped early · Phase 3
Conditions studied: Knee Injury
In brief
Determine the ability of the allograft plug for the treatment of a cartilage injury in the knee
Key facts
- Study ID
- NCT00793104
- Run by
- RTI Surgical
- People needed
- 10
- Starts
- 2008-11-01
- Expected to finish
- 2012-03-01
- Last updated by the study team
- 2013-12-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Kerlan Jobe Orthopaedic Clinic — Los Angeles, California, United States
- Colorado Orthopedic Consultants — Denver, Colorado, United States
- OrthoIndy, Inc — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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