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

• ClinicalTrials.gov Identifier: NCT00984594
• Recruitment Status: Terminated
• First Posted: September 25, 2009
• Results First Posted: June 4, 2014
• Last Update Posted: June 4, 2014
• Sponsor: RTI Surgical
• Information provided by (Responsible Party): RTI Surgical

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Knee Injury	Other: Primary injury site; Other: Backfill site	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 4 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: January 2009
• Actual Primary Completion Date: February 2012
• Actual Study Completion Date: February 2012

Arms and Interventions

Arm	Intervention/treatment
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.
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.

Outcome Measures

Primary Outcome Measures :

1. Knee Injury and Osteoarthritis Outcome Score (KOOS [ 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 (CHA) [ Time Frame: 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. IKDC Assessment [ Time Frame: 24 months ]
   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,
3. Magnetic Resonance Imaging (MRI) Results [ 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.
4. Lysholm Score at 24 Months [ Time Frame: 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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Kentucky

Ellis and Badenhausen Orthopaedics, PSC

Louisville, Kentucky, United States, 40202

Sponsors and Collaborators

RTI Surgical

Investigators

• Principal Investigator: Akbar Nawab, MD; Ellis and Badenhausen Orthopaedics, PSC

More Information

• Responsible Party: RTI Surgical
• ClinicalTrials.gov Identifier: NCT00984594
• Other Study ID Numbers: CR2008
• First Posted: September 25, 2009
• Results First Posted: June 4, 2014
• Last Update Posted: June 4, 2014
• Last Verified: May 2014

Keywords provided by RTI Surgical:

allograft; knee injury; cartilage injury

Additional relevant MeSH terms:

Knee Injuries; Leg Injuries; Wounds and Injuries