Evaluation of the CR Plug (Allograft) for the Treatment of a Cartilage Injury in the Knee.

RTI Surgical

Status and phase: Terminated; Phase 3

Conditions: Knee Injury

Treatments: Procedure: Placement of allograft CR Plug in primary injury site

Study type: Interventional

Funder types: Industry

Identifiers

NCT00793104

WIRB # 20081109 (Other Identifier)

St Francis IRB Project # 571 (Other Identifier)

CRP2008

Details and patient eligibility

About

Determine the ability of the allograft plug for the treatment of a cartilage injury in the knee

Full description

The specific aim in this study is to assess the ability of the CR-Plug to treat osteochondral focal defects of less than 2.5 cm squared at high-load-bearing femoral condyle.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• Skeletally mature
• Have one symptomatic score International Cartilage Repair Score (ICRS) grade 3a, 3b, 3c, 3d, 4a, 4b articular cartilage lesion less than 2.5 cm involving the Medial Femoral Condyle (MFC) or Lateral Femoral Condyle (LFC). Symptoms must include pain, pain with weight bearing and squatting, locking of joints, and/or swelling
• Functional meniscal tissue (defined as 5 mm or more width)
• 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 of 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 yer prior to current study
• Previous surgical meniscus treatments 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 with in 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

CR Plug

Other group

Description:

Placement of allograft CR Plug in primary injury site

Treatment:

Procedure: Placement of allograft CR Plug in primary injury site