DeNovo NT Longitudinal Data Collection (LDC) Knee Study

Knee cartilage injury is a major cause of pain and functional impairment in young to middle
age adults, and can lead to progressive joint degeneration. Adult cartilage has little
regenerative capacity and many of the current treatment options have limited or unknown
durability. DeNovo NT is an allogeneic tissue graft, prepared from donated juvenile
cartilage, which has been shown to have a higher chondrogenic potential than adult
cartilage. The graft involves a single surgery with no need for scaffolds, flaps or
donor-site morbidity. This study will follow the long-term outcomes and durability of DeNovo
NT in patients grafted with this product in the knee, for up to five years. It will enroll
subjects prospectively (at the time of surgery) and retrospectively (those who have been
previously implanted). Data will be collected on patient-reported outcomes, results of knee
examinations, and reoperations and revisions.

Inclusion Criteria:

- Has a contained articular cartilage lesion(s) of the knee or Osteochondritis
Dissecans OCD lesion(s) of the knee for which arthroscopic or surgical intervention
is warranted, OR Has had prior treatment with DeNovo NT for a contained articulare
cartilage lesion(so of the knee or Osteochondritis Dissecans OCD lesion(s) of the
knee

- 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 years

- 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 damage to the subchondral bone that has not/will not be repaired prior to DeNovo
NT treatment