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

Knee Injury Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00984594
• Other study ID #: CR2008
• Status: Terminated
• Phase: Phase 3
• First received: September 24, 2009
• Last updated: May 22, 2014
• Start date: January 2009
• Est. completion date: February 2012

Study information

• Verified date: May 2014
• Source: RTI Surgical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Injuries
• Knee Injury

Intervention

Other:
• Primary injury site
Autograft will be placed in the primary defect site.
• Backfill site
Autograft will be placed in the primary defect site; CR-Plug will be placed in the harvest site.

Locations

Country	Name	City	State
United States	Ellis and Badenhausen Orthopaedics, PSC	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
RTI Surgical

Country where clinical trial is conducted

United States, 

Outcome

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