Evaluation of a Composite Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Knee Osteochondral Defects

Stopped early · Phase 3

Conditions studied: Knee Injury

In brief

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 knee).

Key facts

Study ID

NCT00984594

Run by

RTI Surgical

People needed

4

Starts

2009-01-01

Expected to finish

2012-02-01

Last updated by the study team

2014-06-04

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

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 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

Where it is running

• Ellis and Badenhausen Orthopaedics, PSC — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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