DeNovo NT Longitudinal Data Collection (LDC) Knee Study

Zimmer Biomet

Status: Unknown

Conditions: Degenerative Lesion of Articular Cartilage of Knee; Osteochondritis Dissecans

Treatments: Other: DeNovo NT, Natural Tissue Graft

Study type: Observational

Funder types: Industry

Identifiers

NCT01329445

CSU2010-22B

Details and patient eligibility

About

The purpose of this study is to evaluate the long-term outcomes of DeNovo NT, a tissue product used for the repair of cartilage damage in the knee. This product has been on the market since 2007 and implanted in more than 10,000 patients around the country.

Full description

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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

160 participants in 1 patient group

DeNovo NT patient

Description:

Patients who have received or who are scheduled to receive a DeNovo NT graft for repair of 1-2 knee cartilage lesions.

Treatment:

Other: DeNovo NT, Natural Tissue Graft