DeNovo NT Ankle LDC Study
Post Market, Longitudinal Data Collection Study of Articular Cartilage Lesions in the Ankle Treated With DeNovo(R) NT Natural Tissue Graft
1 other identifier
observational
205
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2011
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 3, 2011
CompletedFirst Posted
Study publicly available on registry
May 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedJanuary 26, 2017
January 1, 2017
8.3 years
May 3, 2011
January 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean scores from patient-reported clinical outcome surveys
5 years
Secondary Outcomes (1)
Incidence of reoperations and revision surgeries
5 years
Study Arms (1)
DeNovo NT Subject
Subjects who have received or who are scheduled to receive a DeNovo NT Graft for repair of a cartilage lesion in the ankle.
Interventions
DeNovo NT is a juvenile cartilagenous tissue graft, inclusive of a viable human cartilage cells. It is provided as particulated tissue pieces of approximately 1mm3 each
Eligibility Criteria
Subjects who have received or who are scheduled to receive a DeNovo NT graft for repair of a cartilage lesion in the ankle.
You may not 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
University of California, Davis at UC Davis Medical Center
Sacramento, California, 95817, United States
Tripler Army Medical Center
Honolulu, Hawaii, 96859, United States
MedStar Health Research Institute at Union Memorial Hospital
Baltimore, Maryland, 21218, United States
Minnesota Orthopedic Sports Medicine Institue at Twin Cities Orthopedics
Edina, Minnesota, 55435, United States
OhioHealth Research Institute at Orthopedic Foot & Ankle Center
Westerville, Ohio, 43082, United States
San Antonio Military Medical Center/Brooke Army Medical Center
Fort Sam Houston, Texas, 78248, United States
The Orthopaedic Foot & Ankle Center of Washington
Falls Church, Virginia, 22042, United States
Madigan Army Medical Center
Tacoma, Washington, 98431, United States
Related Publications (1)
Coetzee JC, Giza E, Schon LC, Berlet GC, Neufeld S, Stone RM, Wilson EL. Treatment of osteochondral lesions of the talus with particulated juvenile cartilage. Foot Ankle Int. 2013 Sep;34(9):1205-11. doi: 10.1177/1071100713485739. Epub 2013 Apr 10.
PMID: 23576118RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2011
First Posted
May 5, 2011
Study Start
March 1, 2011
Primary Completion
July 1, 2019
Study Completion
September 1, 2019
Last Updated
January 26, 2017
Record last verified: 2017-01