Clinical Trial: DeNovo NT Longitudinal Data Collection (LDC) Knee Study
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational
Official Title: Post Market, Longitudinal Data Collection Study of DeNovo NT for Articular Cartilage Defects of the Knee
Brief 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 Summary: 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.
Sponsor: Zimmer Orthobiologics, Inc.
Current Primary Outcome: Mean scores from patient-reported clinical outcome surveys [ Time Frame: 5 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Incidence of reoperations and revision surgeries [ Time Frame: 5 Years ]
Original Secondary Outcome: Same as current
Information By: Zimmer Orthobiologics, Inc.
Dates:
Date Received: April 1, 2011
Date Started: February 2011
Date Completion: December 2021
Last Updated: January 25, 2017
Last Verified: December 2016
