Clinical Trial: DeNovo NT Ankle LDC Study

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Post Market, Longitudinal Data Collection Study of Articular Cartilage Lesions in the Ankle Treated With DeNovo(R) NT Natural Tissue Graft

Brief Summary: The purpose of this post-market clinical study is to collect long-term outcomes for DeNovo NT Graft treatment of articular cartilage lesions in the ankle in a standard clinical setting. Outcomes to be assessed include pain, function, activity levels and healthcare resource use.

Detailed Summary:

Articular cartilage lesions in the ankle can cause significant pain and loss of function for young to middle age adults. There are several treatment options for symptomatic articular cartilage injuries depending on a patient's age, symptoms and duration of complaints in addition to the size and condition of the lesion. DeNovo NT Natural Tissue Graft is comprised of fresh particulated juvenile cartilage pieces that are secured inside articular cartilage lesions using fibrin adhesive. DeNovo NT Graft was developed due to the current need for expanded treatment options for the treatment of cartilage lesions, especially large lesions.

This post-market, multicenter, longitudinal data collection study was established to collect clinical outcomes of subjects implanted with DeNovo NT Graft. Data may be obtained either retrospectively or prospectively from patients implanted or to be implanted with DeNovo NT Graft for the treatment of lesion in the ankle. Data to be collected include details of the operative procedure as well as subject pain, function, activity levels, and healthcare resource use through a five year post-operative follow-up period.

Sponsor: Zimmer Orthobiologics, Inc.

Current Primary Outcome: Mean scores from patient-reported clinical outcome surveys [ Time Frame: 5 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Incidence of reoperations and revision surgeries [ Time Frame: 5 years ]

Original Secondary Outcome: Same as current

Information By: Zimmer Orthobiologics, Inc.

Dates:
Date Received: May 3, 2011
Date Started: March 2011
Date Completion: September 2019
Last Updated: January 25, 2017
Last Verified: January 2017