DeNovo NT Ankle LDC Study
Status unconfirmed
Conditions studied: Defect of Articular Cartilage, Osteochondral Lesion of Talus, Osteochondritis Dissecans
In brief
The purpose of this post-market clinical study is to collect long-term outcomes for DeNovo NT Graft treatment of articular cartilage lesions in the ankle in a standard clinical setting. Outcomes to be assessed include pain, function, activity levels and healthcare resource use.
Key facts
- Study ID
- NCT01347892
- Run by
- Zimmer Orthobiologics, Inc.
- People needed
- 205
- Starts
- 2011-03-01
- Expected to finish
- 2019-09-01
- 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 an articular cartilage lesion(s) in the ankle for which arthroscopic or surgical intervention with DeNovo NT Graft is warranted or has had prior treatment with DeNovo NT Graft for an articular cartilage lesion(s) in the ankle
- 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 at the time of consent
- 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 medical history that would likely make the subject unreliable for the study, or any combination of variables in the investigator's judgment that should exclude a potential subject
Where it is running
- University of California, Davis at UC Davis Medical Center — Sacramento, California, United States
- Tripler Army Medical Center — Honolulu, Hawaii, United States
- MedStar Health Research Institute at Union Memorial Hospital — Baltimore, Maryland, United States
- Minnesota Orthopedic Sports Medicine Institue at Twin Cities Orthopedics — Edina, Minnesota, United States
- OhioHealth Research Institute at Orthopedic Foot & Ankle Center — Westerville, Ohio, United States
- San Antonio Military Medical Center/Brooke Army Medical Center — Fort Sam Houston, Texas, United States
- The Orthopaedic Foot & Ankle Center of Washington — Falls Church, Virginia, United States
- Madigan Army Medical Center — Tacoma, Washington, United States
Full record on ClinicalTrials.gov
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