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

Evaluation of the Composite of Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Focal Cartilage Lesions in the Femoral Condyle

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

Study Overview

• Status: Terminated
• Conditions: Knee Injury
• Intervention / Treatment: Procedure: Placement of allograft CR Plug in primary injury site

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90045
      • Kerlan Jobe Orthopaedic Clinic
  • Colorado
    • Denver, Colorado, United States, 80012
      • Colorado Orthopedic Consultants
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • OrthoIndy, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: CR Plug; Placement of allograft CR Plug in primary injury site	Procedure: Placement of allograft CR Plug in primary injury site; Core defect and implant allograft CR plug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	24 months

Collaborators and Investigators

• Sponsor: RTI Surgical
• Investigators: Principal Investigator: Jack Farr, MD, PhD, OrthoIndy, Inc; Principal Investigator: Ralph A Gambardella, MD, Kerlan Jobe Orthopaedic Clinic; Principal Investigator: Stewart Weinerman, MD, Colorado Orthopedic Consultants

Publications and helpful links

Helpful Links

• Click here to find more information from OrthoIndy

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: November 17, 2008
• First Submitted That Met QC Criteria: November 18, 2008
• First Posted (Estimate): November 19, 2008

Study Record Updates

• Last Update Posted (Estimate): December 25, 2013
• Last Update Submitted That Met QC Criteria: November 6, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: allograft; cartilage injury; knee injury; Osteochondral defects in the articular femoral cartilage
• Additional Relevant MeSH Terms: Leg Injuries; Wounds and Injuries; Knee Injuries
• Other Study ID Numbers: CRP2008; WIRB # 20081109 (Other Identifier: Western IRB); St Francis IRB Project # 571 (Other Identifier: St. Francis IRB)