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

RTI Surgical

Status and phase: Terminated; Phase 3

Conditions: Knee Injury

Treatments: Other: Primary injury site; Other: Backfill site

Study type: Interventional

Funder types: Industry

Identifiers

NCT00984594

CR2008

Details and patient eligibility

About

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).

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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4 participants in 2 patient groups

Primary injury site

Other group

Description:

CR-Plug will be placed in the site of the primary injury

Treatment:

Other: Primary injury site

Backfill site

Other group

Description:

Autograft will be placed in the site of the primary injury; CR Plug will be placed in the harvest site

Treatment:

Other: Backfill site