Overview

This trial is active, not recruiting.

Conditions defect of articular cartilage, osteochondral lesion of talus, osteochondritis dissecans
Treatment denovo nt natural tissue graft
Sponsor Zimmer Orthobiologics, Inc.
Start date March 2011
End date July 2019
Trial size 205 participants
Trial identifier NCT01347892, CSU2010-21B

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Arm
Subjects who have received or who are scheduled to receive a DeNovo NT Graft for repair of a cartilage lesion in the ankle.
denovo nt natural tissue graft DeNovo NT
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

Primary Outcomes

Measure
Mean scores from patient-reported clinical outcome surveys
time frame: 5 years

Secondary Outcomes

Measure
Incidence of reoperations and revision surgeries
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Post Market, Longitudinal Data Collection Study of Articular Cartilage Lesions in the Ankle Treated With DeNovo(R) NT Natural Tissue Graft
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Zimmer Orthobiologics, Inc..