NCT00984594

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: RTI Surgical · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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 of smaller, focal defects (like the injury the patient has to their knee).

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.

Conditions

• Knee Injury

Interventions

Type	Name	Description
OTHER	Primary injury site	Autograft will be placed in the primary defect site.
OTHER	Backfill site	Autograft will be placed in the primary defect site; CR-Plug will be placed in the harvest site.

Timeline

• Start date: 2009-01-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2009-09-25
• Last updated: 2014-06-04
• Results posted: 2014-06-04

Locations

1 site across 1 country: United States