NCT01329445

DeNovo NT Longitudinal Data Collection (LDC) Knee Study

Post Market, Longitudinal Data Collection Study of DeNovo NT for Articular Cartilage Defects of the Knee

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 160 (actual)
• Sponsor: Zimmer Orthobiologics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Degenerative Lesion of Articular Cartilage of Knee
• Osteochondritis Dissecans

Interventions

Type	Name	Description
OTHER	DeNovo NT, Natural Tissue Graft	DeNovo NT Natural Tissue Graft of 1 or 2 lesions up to 5 cm squared in area.

Timeline

• Start date: 2011-02-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2011-04-06
• Last updated: 2017-01-26

Locations

15 sites across 1 country: United States