Status:
TERMINATED
Evaluation of the CR Plug (Allograft) for the Treatment of a Cartilage Injury in the Knee.
Lead Sponsor:
RTI Surgical
Conditions:
Knee Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Determine the ability of the allograft plug for the treatment of a cartilage injury in the knee
Detailed Description
The specific aim in this study is to assess the ability of the CR-Plug to treat osteochondral focal defects of less than 2.5 cm squared at high-load-bearing femoral condyle.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00793104
Start Date
November 1 2008
End Date
March 1 2012
Last Update
December 25 2013
Active Locations (3)
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1
Kerlan Jobe Orthopaedic Clinic
Los Angeles, California, United States, 90045
2
Colorado Orthopedic Consultants
Denver, Colorado, United States, 80012
3
OrthoIndy, Inc
Indianapolis, Indiana, United States, 46237