Clinical trial NCT00984594: Evaluation of a Composite Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Knee Osteochondral Defects
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Knee Injury
Keywords: allograft
knee injury
cartilage injury
Lead sponsor: RTI Surgical
Sponsor class: INDUSTRY
First posted: 2009-09-25
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS
timeFrame: 24 months
Secondary outcomes:
measure: Current Health Assessment (CHA)
timeFrame: 24 months
measure: IKDC Assessment
timeFrame: 24 months
measure: Magnetic Resonance Imaging (MRI) Results
timeFrame: 24 months
measure: Lysholm Score at 24 Months
timeFrame: 24 months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Ellis and Badenhausen Orthopaedics, PSC
state: Kentucky
Study officials:
affiliation: Ellis and Badenhausen Orthopaedics, PSC
name: Akbar Nawab, MD
role: PRINCIPAL_INVESTIGATOR
References: