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

Phase 3

Completed

• Conditions: Knee Injury
• Interventions: Other: CR Plug

• Registration Number: NCT00821873
• Lead Sponsor: RTI Surgical

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 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 Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-01-12
• Study First Submitted QC: 2009-01-13
• Study First Posted: 2009-01-14
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Results First Submitted: 2013-08-01
• Results First Submitted QC: 2013-10-14
• Status Verified: 2013-11
• Results First Posted: 2013-11-06
• Last Update Submitted: 2013-11-06
• Last Update Posted: 2013-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CR Plug BackFill	CR Plug	Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site

Primary Outcome Measures

Name	Time	Method
MRI to Evaluate Success of Outcome.	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.

Trial Locations

Locations (4)

Colorado Orthopedic Consultants; 🇺🇸 Englewood, Colorado, United States

The Orthopedic Clinic Assoc; 🇺🇸 Phoenix, Arizona, United States

American Sports Medicine Institute; 🇺🇸 Birmingham, Alabama, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States