Clinical Trial: Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site From an Autograft in the Knee.
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
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.
Detailed 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 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).
Sponsor: RTI Surgical
Current Primary Outcome: 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.
Original Primary Outcome: The CR-Plug to repair the harvest site defect left during the OATS procedure, the harvest site will be evaluated at three (3) months, six (6) months, and twelve (12) months post-operatively. MRI and X-Ray will be used to evaluate success of outcome. [ Time Frame: Baseline, 3 months, 6 months and 12 months ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: RTI Surgical
Dates:
Date Received: January 12, 2009
Date Started: December 2008
Date Completion:
Last Updated: November 6, 2013
Last Verified: November 2013
