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

NCT ID: NCT00984594

Last Updated: 2014-06-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2012-02-29

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.

Conditions

Knee Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Primary injury site

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

Group Type: OTHER

Primary injury site

Intervention Type: OTHER

Autograft will be placed in the primary defect site.

Backfill site

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

Group Type: OTHER

Backfill site

Intervention Type: OTHER

Autograft will be placed in the primary defect site; CR-Plug will be placed in the harvest site.

Interventions

Primary injury site

Autograft will be placed in the primary defect site.

Intervention Type: OTHER

Backfill site

Autograft will be placed in the primary defect site; CR-Plug will be placed in the harvest site.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

RTI Surgical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Akbar Nawab, MD

Role: PRINCIPAL_INVESTIGATOR

Ellis and Badenhausen Orthopaedics, PSC

Locations

Ellis and Badenhausen Orthopaedics, PSC

Louisville, Kentucky, United States

Countries

United States

Other Identifiers

CR2008

Identifier Type: -

Identifier Source: org_study_id