DeNovo NT Longitudinal Data Collection (LDC) Knee Study

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Degenerative Lesion of Articular Cartilage of Knee
Osteochondritis
Osteochondritis Dissecans

Clinical Trial Details

NCT number	NCT01329445
Study type	Observational
Source	Zimmer Orthobiologics, Inc.
Contact
Status	Active, not recruiting
Phase	N/A
Start date	February 2011
Completion date	December 2021

View Details

See also
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Completed	`NCT02397278` - Intra Articular Injections With Platelet Rich Plasma in Patients With Juvenile Osteochondritis Dissecans of the Knee	N/A
Active, not recruiting	`NCT01347892` - DeNovo NT Ankle LDC Study	N/A
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Recruiting	`NCT01694823` - Safety and Efficacy Study of Cells Sheet-Autologous Chondrocyte Implantation to Treat Articular Cartilage Defects	Phase 1/Phase 2
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