DeNovo NT Ankle LDC Study

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.

Potential subjects are screened for study entry based on a preliminary review of the
inclusion and exclusion criteria as it applies to their pre-operative status (unless
otherwise noted).

Inclusion Criteria:

- Has an articular cartilage lesion(s) in the ankle for which arthroscopic or surgical
intervention with DeNovo NT Graft is warranted or has had prior treatment with DeNovo
NT Graft for an articular cartilage lesion(s) in the ankle

- Has voluntarily signed the IRB approved informed consent

- Is of stable health and is able to undergo surgery

- Is male or female over the age of 18 at the time of consent

- Is physically and mentally willing and able to comply with post-operative
rehabilitation and routinely scheduled clinical visits.

Exclusion Criteria:

- Displays a high surgical risk as determined by the investigative surgeon

- Is pregnant or breast-feeding

- Has a clinically diagnosed autoimmune disease

- Has an active joint infection or history of chronic joint infection at the surgical
site

- Has medical history that would likely make the subject unreliable for the study, or
any combination of variables in the investigator's judgment that should exclude a
potential subject