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

• ClinicalTrials.gov Identifier: NCT00793104
• Recruitment Status: Terminated
• First Posted: November 19, 2008
• Results First Posted: December 25, 2013
• Last Update Posted: December 25, 2013
• Sponsor: RTI Surgical
• Information provided by (Responsible Party): RTI Surgical

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Knee Injury	Procedure: Placement of allograft CR Plug in primary injury site	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Composite of Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Focal Cartilage Lesions in the Femoral Condyle
• Study Start Date: November 2008
• Actual Primary Completion Date: March 2012
• Actual Study Completion Date: March 2012

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 24 Months [ Time Frame: 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 :

1. Current Health Assessment [ Time Frame: 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.
2. Lysholm With Tegner Score [ Time Frame: 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.
3. International Knee Documentation Committee (IKDC) at 24 Months. [ Time Frame: 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.
4. MRI Evaluation Score [ Time Frame: 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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, California

Kerlan Jobe Orthopaedic Clinic

Los Angeles, California, United States, 90045

United States, Colorado

Colorado Orthopedic Consultants

Denver, Colorado, United States, 80012

United States, Indiana

OrthoIndy, Inc

Indianapolis, Indiana, United States, 46237

Sponsors and Collaborators

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

More Information

Additional Information:

Click here to find more information from OrthoIndy 

• Responsible Party: RTI Surgical
• ClinicalTrials.gov Identifier: NCT00793104
• Other Study ID Numbers: CRP2008; WIRB # 20081109 ( Other Identifier: Western IRB ); St Francis IRB Project # 571 ( Other Identifier: St. Francis IRB )
• First Posted: November 19, 2008
• Results First Posted: December 25, 2013
• Last Update Posted: December 25, 2013
• Last Verified: November 2013

Keywords provided by RTI Surgical:

allograft; knee injury; cartilage injury; Osteochondral defects in the articular femoral cartilage

Additional relevant MeSH terms:

Wounds and Injuries; Knee Injuries; Leg Injuries