DeNovo NT Ankle LDC Study

Defect of Articular Cartilage Clinical Trial

Official title:

Post Market, Longitudinal Data Collection Study of Articular Cartilage Lesions in the Ankle Treated With DeNovo(R) NT Natural Tissue Graft

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01347892
• Other study ID #: CSU2010-21B
• Status: Active, not recruiting
• Phase: N/A
• First received: May 3, 2011
• Last updated: January 25, 2017
• Start date: March 2011
• Est. completion date: September 2019

Study information

• Verified date: January 2017
• Source: Zimmer Orthobiologics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 205
• Est. completion date: September 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cartilage Diseases
• Defect of Articular Cartilage
• Osteochondral Lesion of Talus
• Osteochondritis
• Osteochondritis Dissecans

Intervention

Other:
• DeNovo NT Natural Tissue Graft
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

Locations

Country	Name	City	State
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	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	Tripler Army Medical Center	Honolulu	Hawaii
United States	University of California, Davis at UC Davis Medical Center	Sacramento	California
United States	Madigan Army Medical Center	Tacoma	Washington
United States	OhioHealth Research Institute at Orthopedic Foot & Ankle Center	Westerville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Orthobiologics, Inc.

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean scores from patient-reported clinical outcome surveys		5 years
Secondary	Incidence of reoperations and revision surgeries		5 years