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