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

Knee Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00793104
• Other study ID #: CRP2008
• Secondary ID: WIRB # 20081109S
• Status: Terminated
• Phase: Phase 3
• First received: November 17, 2008
• Last updated: November 6, 2013
• Start date: November 2008
• Est. completion date: March 2012

Study information

• Verified date: November 2013
• Source: RTI Surgical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Injuries
• Knee Injury

Intervention

Procedure:
• Placement of allograft CR Plug in primary injury site
Core defect and implant allograft CR plug

Locations

Country	Name	City	State
United States	Colorado Orthopedic Consultants	Denver	Colorado
United States	OrthoIndy, Inc	Indianapolis	Indiana
United States	Kerlan Jobe Orthopaedic Clinic	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
RTI Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   Click here to find more information from OrthoIndy