DeNovo NT Ankle LDC Study
- Conditions
- Osteochondritis DissecansDefect of Articular CartilageOsteochondral Lesion of Talus
- Interventions
- Other: DeNovo NT Natural Tissue Graft
- Registration Number
- NCT01347892
- Lead Sponsor
- Zimmer Orthobiologics, Inc.
- Brief Summary
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.
- Detailed Description
Articular cartilage lesions in the ankle can cause significant pain and loss of function for young to middle age adults. There are several treatment options for symptomatic articular cartilage injuries depending on a patient's age, symptoms and duration of complaints in addition to the size and condition of the lesion. DeNovo NT Natural Tissue Graft is comprised of fresh particulated juvenile cartilage pieces that are secured inside articular cartilage lesions using fibrin adhesive. DeNovo NT Graft was developed due to the current need for expanded treatment options for the treatment of cartilage lesions, especially large lesions.
This post-market, multicenter, longitudinal data collection study was established to collect clinical outcomes of subjects implanted with DeNovo NT Graft. Data may be obtained either retrospectively or prospectively from patients implanted or to be implanted with DeNovo NT Graft for the treatment of lesion in the ankle. Data to be collected include details of the operative procedure as well as subject pain, function, activity levels, and healthcare resource use through a five year post-operative follow-up period.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 205
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description DeNovo NT Subject DeNovo NT Natural Tissue Graft Subjects who have received or who are scheduled to receive a DeNovo NT Graft for repair of a cartilage lesion in the ankle.
- Primary Outcome Measures
Name Time Method Mean scores from patient-reported clinical outcome surveys 5 years
- Secondary Outcome Measures
Name Time Method Incidence of reoperations and revision surgeries 5 years
Trial Locations
- Locations (8)
University of California, Davis at UC Davis Medical Center
🇺🇸Sacramento, California, United States
Tripler Army Medical Center
🇺🇸Honolulu, Hawaii, 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
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
The Orthopaedic Foot & Ankle Center of Washington
🇺🇸Falls Church, Virginia, United States
San Antonio Military Medical Center/Brooke Army Medical Center
🇺🇸Ft Sam Houston, Texas, United States
MedStar Health Research Institute at Union Memorial Hospital
🇺🇸Baltimore, Maryland, United States