Evaluation of the CR Plug (Allograft) for the Treatment of a Cartilage Injury in the Knee.

Study Overview
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Brief Summary
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Determine the ability of the allograft plug for the treatment of a cartilage injury in the knee

Detailed Description
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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.

Official Title
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Evaluation of the Composite of Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Focal Cartilage Lesions in the Femoral Condyle

Conditions
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Knee Injury

Intervention / Treatment
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* Procedure: Placement of allograft CR Plug in primary injury site


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CR Plug<br>Placement of allograft CR Plug in primary injury site | Procedure: Placement of allograft CR Plug in primary injury site<br>* Core defect and implant allograft CR plug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 24 Months | The outcome at 24 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Current Health Assessment | Evaluation on the Current Health Assessment at 24 months. Scores are transformed to a 0-100 scale, with zero representing a self-graded perception of extremely poor health and 100 representing no health problems. Scores between 0 and 100 represent the percentage of total possible score achieved. | 24 months, MRI only at 12 and 24 months | 
| Lysholm With Tegner Score | The Tegner activity scale was designed as a score of activity level to complement other functional scores (eg the Lysholm knee score) for patients with ligamentous injuries. The instrument scores a person's activity level between 0 and 100 where 0 is 'on sick leave/disability' and 100 is 'participation in competitive sports at a full, unhindered level. | 24 months | 
| International Knee Documentation Committee (IKDC) at 24 Months. | The International Knee Documentation Committee scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved. | 24 months | 
| MRI Evaluation Score | MRI images were graded by a radiologist with regard to the incorporation of the CR graft in both the cancellous and cortical portions of the bone at the graft site. The raw scores were converted to an index scale form 0 to 100, with 0 representing failure of the graft to incorporate and 100 representing complete incorporation of the graft. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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allograft, knee injury, cartilage injury, Osteochondral defects in the articular femoral cartilage