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DeNovo NT Ankle LDC Study

This study is currently recruiting participants.
Verified September 2012 by Zimmer Orthobiologics, Inc.
Sponsor:
Information provided by (Responsible Party):
Zimmer Orthobiologics, Inc.
ClinicalTrials.gov Identifier:
NCT01347892
First received: May 3, 2011
Last updated: September 26, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Defect of Articular Cartilage
Osteochondral Lesion of Talus
Osteochondritis Dissecans
 Other: DeNovo NT Natural Tissue Graft

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Post Market, Longitudinal Data Collection Study of Articular Cartilage Lesions in the Ankle Treated With DeNovo(R) NT Natural Tissue Graft

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Zimmer Orthobiologics, Inc.:

Primary Outcome Measures:
  • Mean scores from patient-reported clinical outcome surveys [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of reoperations and revision surgeries [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: March 2011
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
 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
Other Name: DeNovo NT

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01347892

Locations
United States, California
University of California, Davis at UC Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Sheldon I Coleman, MD     916-734-6291     sheldon.coleman@udcmc.ucdavis.edu    
Contact: Eric Giza, MD     916-734-5876     eric.giza@ucdmc.ucdavis.edu    
Principal Investigator: Eric Giza, MD            
United States, Hawaii
Tripler Army Medical Center Recruiting
Honolulu, Hawaii, United States, 96859
Contact: Sarah Raybin     808-433-4353     sarah.raybin.ctr@us.army.mil    
Principal Investigator: Adam T Groth, MD            
United States, Maryland
MedStar Health Research Institute at Union Memorial Hospital Recruiting
Baltimore, Maryland, United States, 21218
Contact: Flossine Brown, BS, CCRC     410-554-4451     flossine.brown@medstar.net    
Principal Investigator: Lew Schon, MD            
United States, Minnesota
Minnesota Orthopedic Sports Medicine Institue at Twin Cities Orthopedics Recruiting
Edina, Minnesota, United States, 55435
Contact: Becky Stone, MS, ATC     952-456-7136     beckystone@tcomn.com    
Principal Investigator: Johannes Christiaan (Chris) Coetzee, MD, FRCSC            
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Niall Smyth, MD     617-817-4159     SmythN@HSS.EDU    
Principal Investigator: John G Kennedy, MD            
United States, Ohio
OhioHealth Research Institute at Orthopedic Foot & Ankle Center Recruiting
Westerville, Ohio, United States, 43082
Contact: Emily Stansbury     614-895-8747     StansburyET@orthofootankle.com    
Principal Investigator: Gregory Berlet, MD            
United States, Texas
San Antonio Military Medical Center/Brooke Army Medical Center Recruiting
Ft Sam Houston, Texas, United States, 78248
Contact: Kerri E Anguiano     210-916-9181     Kerri.e.anguiano.ctr@amedd.army.mil    
Principal Investigator: Patrik Osborn, MD            
United States, Virginia
The Orthopaedic Foot & Ankle Center of Washington Recruiting
Falls Church, Virginia, United States, 22042
Contact: Josie Hyams, PA-C     703-769-8420     jhyams@footankledc.com    
Principal Investigator: Steven K Neufeld, MD            
Sponsors and Collaborators
Zimmer Orthobiologics, Inc.
  More Information

No publications provided

Responsible Party: Zimmer Orthobiologics, Inc.
ClinicalTrials.gov Identifier: NCT01347892     History of Changes
Other Study ID Numbers: CSU2010-21B
Study First Received: May 3, 2011
Last Updated: September 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Zimmer Orthobiologics, Inc.:
Talar injury
ankle
lesion
defect
cartilage repair

Additional relevant MeSH terms:
Osteochondritis
Osteochondritis Dissecans
Bone Diseases
 Musculoskeletal Diseases
Cartilage Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 21, 2013