NCT01410136

Chondrofix Osteochondral Allograft Prospective Study

A Post Market Study to Evaluate the Chondrofix® Osteochondral Allograft Utilized for Treatment of Subjects With Cartilage Lesions in the Knee

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Zimmer Orthobiologics, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Articular Cartilage Disorder
• Degeneration; Articular Cartilage
• Chronic Cartilage Injury
• Acute Cartilage Injury
• Defect of Articular Cartilage

Interventions

Type	Name	Description
PROCEDURE	Chondrofix Osteochondral Allograft	Allogeneic, cylindrical, decellularized, osteochondral graft composed of hyaline cartilage and bone

Timeline

• Start date: 2011-04-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2011-08-04
• Last updated: 2014-08-11

Locations

5 sites across 1 country: United States