Clinical Trial: Chondrofix Osteochondral Allograft Prospective Study

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Zimmer Orthobiologics, Inc.

Current Primary Outcome: KOOS Subscale [ Time Frame: 24 Months ]

The overall mean change from baseline to 24 months in the KOOS Pain and KOOS Function in Daily Living (ADL) subscale scores.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • X-ray & MRI Evaluation [ Time Frame: Baseline and 1.5, 3, 6, 12, 24, & 60 months ]
  • IKDC Knee Examination [ Time Frame: Baseline & 1.5, 3, 6, 12, 24, & 60 months ]
  • Subject Reported Questionnaires [ Time Frame: Baseline and 1.5, 3, 6, 12, 24, 36, 48, and 60 months ]


Original Secondary Outcome: Same as current

Information By: Zimmer Orthobiologics, Inc.

Dates:
Date Received: August 2, 2011
Date Started: April 2011
Date Completion:
Last Updated: August 7, 2014
Last Verified: August 2014