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

Phase 3

Terminated

Conditions: Knee Injury

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

Registration Number: NCT00793104

Lead Sponsor: RTI Surgical

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

Detailed 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 10

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CR Plug	Placement of allograft CR Plug in primary injury site	Placement of allograft CR Plug in primary injury site

Primary Outcome Measures

Name	Time	Method
The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 24 Months	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.

Secondary Outcome Measures

Name	Time	Method
Lysholm With Tegner Score	24 months	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.
International Knee Documentation Committee (IKDC) at 24 Months.	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.
MRI Evaluation Score	24 months	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.
Current Health Assessment	24 months, MRI only at 12 and 24 months	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.

Trial Locations

Locations (3): Colorado Orthopedic Consultants
🇺🇸
Denver, Colorado, United States
OrthoIndy, Inc
🇺🇸
Indianapolis, Indiana, United States
Kerlan Jobe Orthopaedic Clinic
🇺🇸
Los Angeles, California, United States