Chondrofix Osteochondral Allograft Prospective Study

Status Terminated

Clinical Trial Summary

The overall study objective is to evaluate Chondrofix Osteochondral Allograft ("Chondrofix") for the repair of osteochondral lesions in the knee. This includes, but is not limited to primary cartilage lesion repair and revision of failed prior cartilage repair treatments. The study hypothesis is that Chondrofix Allograft will provide pain relief and functional improvement as demonstrated by a comparative analysis of baseline clinical evaluations at 24 months of follow-up.

Clinical Trial Description

Knee cartilage injuries are a major cause of pain and functional impairment in young to middle age adults and can lead to progressive joint degeneration. In response to challenges with current cartilage repair options, Chondrofix Allograft was developed as an off-the-shelf treatment option adding to the variety of cartilage reparation offerings.

This study is a multicenter, prospective, post-market clinical outcomes study designed to assess the clinical outcomes of Chondrofix Allograft used in the treatment of both primary and revision cartilage repair cases. Study design includes up to 6 qualified investigational sites with 50 subjects enrolled across all centers during an 18 month enrollment period. Study subjects will be followed postoperatively for 5 years. The Investigators who are responsible for the conduct of this study in compliance with this protocol will be orthopedic surgeons who are skilled in the techniques of articular cartilage repair. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01410136
Study type	Interventional
Source	Zimmer Orthobiologics, Inc.
Contact
Status	Terminated
Phase	N/A
Start date	April 2011
Completion date	March 2014

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