DeNovo NT Longitudinal Data Collection (LDC) Knee Study

Status unconfirmed

Conditions studied: Degenerative Lesion of Articular Cartilage of Knee, Osteochondritis Dissecans

In brief

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.

Key facts

Study ID

NCT01329445

Run by

Zimmer Orthobiologics, Inc.

People needed

160

Starts

2011-02-01

Expected to finish

2021-12-01

Last updated by the study team

2017-01-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Specialized Orthopaedic Surgery & Spine Center — Huntsville, Alabama, United States
• Naval Medical Center San Diego — San Diego, California, United States
• Colorado Orthopedic Consultants — Aurora, Colorado, United States
• Emory University — Atlanta, Georgia, United States
• Midwest Orthopaedics at Rush Univ Hospital — Chicago, Illinois, United States
• OrthoIndy — Greenwood, Indiana, United States
• Sinai Hospital of Baltimore — Baltimore, Maryland, United States
• New Mexico Orthopaedic Associates — Albuquerque, New Mexico, United States
• OrthoCarolina Research Institute — Charlotte, North Carolina, United States
• Specialized Orthopaedics & Sports Medicine — Columbus, Ohio, United States
• Cleveland Clinic Sports Health Center — Garfield Heights, Ohio, United States
• University of Virginia — Charlottesville, Virginia, United States
• Jordan Young Institute — Virginia Beach, Virginia, United States
• Aurora Baycare Medical Center — Green Bay, Wisconsin, United States
• Dean Clinic — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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