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

Phase 3

Terminated

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 knee).

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Primary injury site	Primary injury site	CR-Plug will be placed in the site of the primary injury
Backfill site	Backfill site	Autograft will be placed in the site of the primary injury; CR Plug will be placed in the harvest site

Primary Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcome Score (KOOS	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.

Secondary Outcome Measures

Name	Time	Method
Magnetic Resonance Imaging (MRI) Results	24 months	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.
Current Health Assessment (CHA)	24 months	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.
IKDC Assessment	24 months	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,
Lysholm Score at 24 Months	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.