Clinical trial NCT01347892: DeNovo NT Ankle LDC Study
Official title: Post Market, Longitudinal Data Collection Study of Articular Cartilage Lesions in the Ankle Treated With DeNovo(R) NT Natural Tissue Graft
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Defect of Articular Cartilage
Osteochondral Lesion of Talus
Osteochondritis Dissecans
Keywords: Talar injury
ankle
lesion
defect
cartilage repair
Lead sponsor: Zimmer Orthobiologics, Inc.
Sponsor class: INDUSTRY
First posted: 2011-05-05
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have received or who are scheduled to receive a DeNovo NT graft for repair of a cartilage lesion in the ankle.

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.

Eligibility criteria: Potential subjects are screened for study entry based on a preliminary review of the inclusion and exclusion criteria as it applies to their pre-operative status (unless otherwise noted).

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mean scores from patient-reported clinical outcome surveys
timeFrame: 5 years
Secondary outcomes:
measure: Incidence of reoperations and revision surgeries
timeFrame: 5 years
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis at UC Davis Medical Center
state: California
city: Honolulu
country: United States
facility: Tripler Army Medical Center
state: Hawaii
city: Baltimore
country: United States
facility: MedStar Health Research Institute at Union Memorial Hospital
state: Maryland
city: Edina
country: United States
facility: Minnesota Orthopedic Sports Medicine Institue at Twin Cities Orthopedics
state: Minnesota
city: Westerville
country: United States
facility: OhioHealth Research Institute at Orthopedic Foot & Ankle Center
state: Ohio
city: Ft Sam Houston
country: United States
facility: San Antonio Military Medical Center/Brooke Army Medical Center
state: Texas
city: Falls Church
country: United States
facility: The Orthopaedic Foot & Ankle Center of Washington
state: Virginia
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
References:
citation: 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.