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

Phase 3TerminatedNCT00793104

RTI Surgical10 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Knee Injury

Interventions

Placement of allograft CR Plug in primary injury sitePROCEDURE

Core defect and implant allograft CR plug

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Kerlan Jobe Orthopaedic Clinic

Los Angeles, California, United States

Colorado Orthopedic Consultants

Denver, Colorado, United States

OrthoIndy, Inc

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 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.

Time frame: 24 months

Secondary Outcomes

Current Health Assessment

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.

Time frame: 24 months, MRI only at 12 and 24 months

Lysholm With Tegner Score

The Tegner activity scale was designed as a score of activity level to complement other functional scores (eg the Lysholm knee score) for patients with ligamentous injuries. The instrument scores a person's activity level between 0 and 100 where 0 is 'on sick leave/disability' and 100 is 'participation in competitive sports at a full, unhindered level.

Time frame: 24 months

International Knee Documentation Committee (IKDC) at 24 Months.

The International Knee Documentation Committee 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.

Time frame: 24 months

MRI Evaluation Score

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.