Status:
COMPLETED
Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site From an Autograft in the Knee.
Lead Sponsor:
RTI Surgical
Conditions:
Knee Injury
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
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 c...
Eligibility Criteria
Inclusion
- 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
- Skeletally immature
- Osteoarthritic knees, osteonecrotic knees, osteophyte formation
- Use of any investigational therapy within thirty (30) days prior to the first visit
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00821873
Start Date
December 1 2008
End Date
July 1 2012
Last Update
November 28 2013
Active Locations (4)
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1
American Sports Medicine Institute
Birmingham, Alabama, United States, 35205
2
The Orthopedic Clinic Assoc
Phoenix, Arizona, United States, 85016
3
Colorado Orthopedic Consultants
Englewood, Colorado, United States, 80110
4
Ohio State University
Columbus, Ohio, United States, 43221