Status:
TERMINATED
Evaluation of a Composite Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Knee Osteochondral Defects
Lead Sponsor:
RTI Surgical
Conditions:
Knee Injury
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
The objective of this study is to determine how effective a plug made out of human bone (called "CR-Plug") will be in the treatment of smaller, focal defects (like the injury the patient has to their ...
Detailed Description
The main objective of this double arm study is to test the ability of an allograft plug to provide "successful" repair of less than (\<) 2.5 cm2 osteochondral defect in a low-load-bearing femoral cond...
Eligibility Criteria
Inclusion
- 18 to 55 years
- skeletally mature
- Have a symptomatic score International Cartilage Repair Society (ICRS) grade 3a, 3b, 3c, 3d, 4a, 4b articular cartilage lesion less than 2.5 cm involving the Medial Femoral Condyle or Lateral Femoral Condyle. Symptoms must include pain, pain with weight bearing and squatting, locking of joints and or swelling
- Functional meniscal tissue (defined as 5 mmor greater)
- 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 on 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 year prior to current study
- Previous surgical meniscus treatment 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 within 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
- Microfracture less than one year prior to current study
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00984594
Start Date
January 1 2009
End Date
February 1 2012
Last Update
June 4 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ellis and Badenhausen Orthopaedics, PSC
Louisville, Kentucky, United States, 40202