Evaluation of a Composite Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Knee Osteochondral Defects

Evaluation of the Composite of Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Osteochondral Defects in High-Load-Bearing Region and Low-Load-Bearing Region of the Femoral Condyle

The objective of this study is to determine how effective a plug made out of human bone (called "CR-Plug") will be in the treatment of smaller, focal defects (like the injury the patient has to their knee).

Study Overview

• Status: Terminated
• Conditions: Knee Injury
• Intervention / Treatment: Other: Primary injury site; Other: Backfill site

Detailed Description

The main objective of this double arm study is to test the ability of an allograft plug to provide "successful" repair of less than (<) 2.5 cm2 osteochondral defect in a low-load-bearing femoral condyle region, and a high-load-bearing femoral-condyle region.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Ellis and Badenhausen Orthopaedics, PSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 to 55 years
• skeletally mature
• Have a symptomatic score International Cartilage Repair Society (ICRS) grade 3a, 3b, 3c, 3d, 4a, 4b articular cartilage lesion less than 2.5 cm involving the Medial Femoral Condyle or Lateral Femoral Condyle. Symptoms must include pain, pain with weight bearing and squatting, locking of joints and or swelling
• Functional meniscal tissue (defined as 5 mmor greater)
• 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 on 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 year prior to current study
• Previous surgical meniscus treatment 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 within 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
• Microfracture less than one year prior to current study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Primary injury site; CR-Plug will be placed in the site of the primary injury	Other: Primary injury site; Autograft will be placed in the primary defect site.
Other: Backfill site; Autograft will be placed in the site of the primary injury; CR Plug will be placed in the harvest site	Other: Backfill site; Autograft will be placed in the primary defect site; CR-Plug will be placed in the harvest site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Injury and Osteoarthritis Outcome Score (KOOS	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 (CHA)	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
IKDC Assessment	The International Knee Documentation Committee (IKDC) scores from 24 months are shown. The IKDC is an index score from 0 to 100, with 100 being the best possible score,	24 months
Magnetic Resonance Imaging (MRI) Results	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
Lysholm Score at 24 Months	The Lysholm scores from the 24-month exams are shown. The Lysholm score is an indexed score of knee functional ability, with 0 being the worst score and 100 being the best score, indicating no limitations in activity/function.	24 months

Collaborators and Investigators

• Sponsor: RTI Surgical
• Investigators: Principal Investigator: Akbar Nawab, MD, Ellis and Badenhausen Orthopaedics, PSC

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: September 24, 2009
• First Submitted That Met QC Criteria: September 24, 2009
• First Posted (Estimate): September 25, 2009

Study Record Updates

• Last Update Posted (Estimate): June 4, 2014
• Last Update Submitted That Met QC Criteria: May 22, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: allograft; cartilage injury; knee injury
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries
• Other Study ID Numbers: CR2008