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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
RTI Biologics
ClinicalTrials.gov Identifier:
NCT00984594
First received: September 24, 2009
Last updated: May 2, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Knee Injury
Other: Primary injury site
Other: Backfill site
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by RTI Biologics:

Primary Outcome Measures:
  • Decrease in preoperative pain as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscale [ Time Frame: 3, 6, 12, 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in quality of life scores [ Time Frame: 3, 6, 12, 24 months ] [ Designated as safety issue: No ]
  • KOOS [ Time Frame: 3, 6, 12, 24 months ] [ Designated as safety issue: No ]
  • Improvement in Lysholm with Tegner [ Time Frame: 3, 6, 12, 24 months ] [ Designated as safety issue: No ]
  • International Knee Documentation Committee (IKDC) assessment forms [ Time Frame: 3, 6, 12, 24 months ] [ Designated as safety issue: No ]
  • IKDC objective evaluation [ Time Frame: 3, 6, 12, 24 months ] [ Designated as safety issue: No ]
  • Magnetic Resonance Imaging (MRI) results [ Time Frame: 3, 6, 12, 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2009
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Primary injury site
CR Plug will be placed in the primary injury site.
Other: Primary injury site
Place CR Plug in primary injury site
Backfill site
CR Plug will be placed in site that autograft was harvest for be placed in primary injury site
Other: Backfill site
CR Plug will be placed in site of autograft that will then be placed in the primary injury 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 to 55 years
  • skeletally mature
  • Have a symptomatic score ICRS grade 3a, 3b, 3c, 3d, 4a, 4b articular cartilage lesion less than 2.5 cm involving the MFC or LFC. 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 of Merchant view
  • One or more multiple defects greater than 2.5 cm
  • Osteochondritis dessecans (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00984594

Locations
United States, Kentucky
Ellis and Badenhausen Orthopaedics, PSC
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
RTI Biologics
Investigators
Principal Investigator: Akbar Nawab, MD Ellis and Badenhausen Orthopaedics, PSC
  More Information

No publications provided

Responsible Party: RTI Biologics
ClinicalTrials.gov Identifier: NCT00984594     History of Changes
Other Study ID Numbers: CR2008
Study First Received: September 24, 2009
Last Updated: May 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by RTI Biologics:
allograft
knee injury
cartilage injury

Additional relevant MeSH terms:
Knee Injuries
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on April 15, 2014