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

Study Overview
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Brief Summary
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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).

Detailed Description
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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 condyle region, and a high-load-bearing femoral-condyle region.

Official Title
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Evaluation of the Composite of Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Osteochondral Defects in High-Load-Bearing Region and Low-Load-Bearing Region of the Femoral Condyle

Conditions
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Knee Injury

Intervention / Treatment
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* Other: Primary injury site
* Other: Backfill site


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Primary injury site<br>CR-Plug will be placed in the site of the primary injury | Other: Primary injury site<br>* Autograft will be placed in the primary defect site.<br>|
| Other: Backfill site<br>Autograft will be placed in the site of the primary injury; CR Plug will be placed in the harvest site | Other: Backfill site<br>* Autograft will be placed in the primary defect site; CR-Plug will be placed in the harvest site.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Injury and Osteoarthritis Outcome Score (KOOS | 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 (CHA) | 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 | 
| IKDC Assessment | The International Knee Documentation Committee (IKDC) scores from 24 months are shown. The IKDC is an index score from 0 to 100, with 100 being the best possible score, | 24 months | 
| Magnetic Resonance Imaging (MRI) Results | 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 | 
| Lysholm Score at 24 Months | The Lysholm scores from the 24-month exams are shown. The Lysholm score is an indexed score of knee functional ability, with 0 being the worst score and 100 being the best score, indicating no limitations in activity/function. | 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