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Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site From an Autograft in the Knee. (CRB)

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ClinicalTrials.gov Identifier: NCT00821873
Recruitment Status : Completed
First Posted : January 14, 2009
Results First Posted : November 6, 2013
Last Update Posted : November 28, 2013
Sponsor:
Information provided by (Responsible Party):
RTI Surgical

Study Description
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Brief Summary:
The main objective of this study is to test the ability of an allograft plug to provide a successful repair of an osteochondral defect left at the harvest site during OATS procedure.

Condition or disease Intervention/treatment Phase
Knee Injury Other: CR Plug Phase 3

Detailed Description:
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 at the site that your tissue was removed, thereby filling the hole created during the OATS procedure.At the present, OATS is used for knee articular cartilage defects or injuries smaller than the size of a dime (or 2.5 cm2) in the areas that bear weight have been commonly treated by using a tiny cylinder of the subjects' own tissue called an osteochondral autograft (OATS).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Composite of Cancellous and Demineralized Bone Plug (CR Plug) for Repair of Defects Created at the Harvest Site During the Osteochondral Autograft Transfer System(OATS)Procedure
Study Start Date : December 2008
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: CR Plug BackFill
Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site
 Other: CR Plug
CR Plug will be placed in the harvest site


Outcome Measures
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Primary Outcome Measures :
  1. MRI to Evaluate Success of Outcome. [ Time Frame: 24 months ]

    The CR-Plug to repair the harvest site defect left during the OATS procedure, the harvest site will be evaluated at 24 months post-operatively.

    The MRI scans were evaluated by a radiologist for several categories and these were then scored and transformed to an index, resulting in an outcome score ranging from 0-100 In this scale, 0 is the worst possible and 100 is the best possible score.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Are male or female at least 18 years of age and up to 55 years of age
  • Must be skeletally mature
  • Have a grade III or IV lesion in femoral condyle

Exclusion Criteria:

  • Skeletally immature
  • Osteoarthritic knees, osteonecrotic knees, osteophyte formation
  • Use of any investigational therapy within thirty (30) days prior to the first visit
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821873


Locations
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United States, Alabama
American Sports Medicine Institute
Birmingham, Alabama, United States, 35205
United States, Arizona
The Orthopedic Clinic Assoc
Phoenix, Arizona, United States, 85016
United States, Colorado
Colorado Orthopedic Consultants
Englewood, Colorado, United States, 80110
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43221
Sponsors and Collaborators
RTI Surgical
Investigators
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Principal Investigator: Thomas Carter, MD The Orthopedic Clinic, Assoc
Principal Investigator: David Flanigan, MD The Ohio State Univesity
Principal Investigator: Phillip Stull, MD Colorado Orthopedic Consultants
Principal Investigator: Jeffrey Dugas, MD American Sports Medicine Institute
More Information
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Responsible Party: RTI Surgical
ClinicalTrials.gov Identifier: NCT00821873    
Other Study ID Numbers: CRB2008
WIRB #20080290 ( Other Identifier: Western IRB )
First Posted: January 14, 2009    Key Record Dates
Results First Posted: November 6, 2013
Last Update Posted: November 28, 2013
Last Verified: November 2013
Keywords provided by RTI Surgical:
Cartilage injury
OATS
Knee injury
allograft
autograft
Additional relevant MeSH terms:
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Knee Injuries
Leg Injuries
Wounds and Injuries