DeNovo NT Longitudinal Data Collection (LDC) Knee Study

This study is currently recruiting participants.
Verified October 2013 by Zimmer Orthobiologics, Inc.
Sponsor:
Information provided by (Responsible Party):
Zimmer Orthobiologics, Inc.
ClinicalTrials.gov Identifier:
NCT01329445
First received: April 1, 2011
Last updated: October 14, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to evaluate the long-term outcomes of DeNovo NT, a tissue product used for the repair of cartilage damage in the knee. This product has been on the market since 2007 and implanted in more than 1300 patients around the country.


Condition Intervention
Degenerative Lesion of Articular Cartilage of Knee
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 DeNovo NT for Articular Cartilage Defects of the Knee

Resource links provided by NLM:


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: 400
Study Start Date: February 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 patient
Patients who have received or who are scheduled to receive a DeNovo NT graft for repair of 1-2 knee cartilage lesions.
Other: DeNovo NT, Natural Tissue Graft
DeNovo NT Natural Tissue Graft of 1 or 2 lesions up to 5 cm squared in area.
Other Name: DeNovo NT

Detailed Description:

Knee cartilage injury is a major cause of pain and functional impairment in young to middle age adults, and can lead to progressive joint degeneration. Adult cartilage has little regenerative capacity and many of the current treatment options have limited or unknown durability. DeNovo NT is an allogeneic tissue graft, prepared from donated juvenile cartilage, which has been shown to have a higher chondrogenic potential than adult cartilage. The graft involves a single surgery with no need for scaffolds, flaps or donor-site morbidity. This study will follow the long-term outcomes and durability of DeNovo NT in patients grafted with this product in the knee, for up to five years. It will enroll subjects prospectively (at the time of surgery) and retrospectively (those who have been previously implanted). Data will be collected on patient-reported outcomes, results of knee examinations, and reoperations and revisions.

  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

Patients being recommended for arthroscopic or surgical intervention for articular cartilage lesionis of the knee

Criteria

Inclusion Criteria:

  • Has a contained articular cartilage lesion(s) of the knee or Osteochondritis Dissecans OCD lesion(s) of the knee for which arthroscopic or surgical intervention is warranted, OR Has had prior treatment with DeNovo NT for a contained articulare cartilage lesion(so of the knee or Osteochondritis Dissecans OCD lesion(s) of the knee
  • 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 years
  • 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 damage to the subchondral bone that has not/will not be repaired prior to DeNovo NT treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01329445

Locations
United States, Alabama
Specialized Orthopaedic Surgery & Spine Center Recruiting
Huntsville, Alabama, United States, 35802
Contact: Gary Lawson, CRNP    256-881-5151    glawson@sportsmedlink.com   
Principal Investigator: Eric W. Janssen, MD         
United States, California
Naval Medical Center San Diego Recruiting
San Diego, California, United States, 92134
Contact: Ruth Baer, RN    619-532-7810    ruth.baer.ctr@med.navy.mil   
Principal Investigator: Christopher Dewing, MD         
United States, Colorado
Colorado Orthopedic Consultants Recruiting
Aurora, Colorado, United States, 80012
Contact: Krystal Payton    303-695-6060    krystalpayton@cocortho.com   
Contact: Janell Baker    303-695-6060    janellbaker@cocortho.com   
Principal Investigator: Phillip Stull, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30329
Contact: Kyle Webb    404-778-6381    kyle.webb2@emory.edu   
Principal Investigator: Sameh Labib, MD         
United States, Illinois
Midwest Orthopaedics at Rush Univ Hospital Recruiting
Chicago, Illinois, United States, 60612
Contact: Mukesh Ahuja    312-563-2214    mahuja@rushortho.com   
Principal Investigator: Brian J Cole, MD         
United States, Indiana
OrthoIndy Recruiting
Greenwood, Indiana, United States, 46143
Contact: Vicki Snodgrass-Miller, CCRD    317-884-5230    vsmiller@orthoindy.com   
Principal Investigator: Jack Farr, MD         
United States, Maryland
Sinai Hospital of Baltimore Recruiting
Baltimore, Maryland, United States, 21215
Contact: MaryLou Mullen    410-601-8609    mmullen@lifebridgehealth.org   
Principal Investigator: Michael Mont, MD         
United States, New Mexico
New Mexico Orthopaedic Associates Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Ashley Baldwin    505-724-3236    hailea@nmortho.net   
Principal Investigator: Samuel Tabet, MD         
United States, North Carolina
OrthoCarolina Research Institute Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Caleb Michalek    704-323-3698    caleb.michalek@orthocarolina.com   
Contact: Caryn Thompson, CCRC    704-323-3967    caryn.thompson@orthocarolina.com   
Principal Investigator: James Fleischli, MD         
United States, Ohio
Specialized Orthopaedics & Sports Medicine Recruiting
Columbus, Ohio, United States, 43215
Contact: Kelly Noll    614-461-6634    nollk@specialortho.com   
Principal Investigator: R. Earl Bartley, MD         
Cleveland Clinic Sports Health Center Not yet recruiting
Garfield Heights, Ohio, United States, 44125
Contact: Michelle Hines, RN    216-444-5935    hinesm3@ccf.org   
Principal Investigator: Paul Saluan, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Joe Hart, PhD    434-924-6187    joehart@virginia.edu   
Principal Investigator: David R Diduch, MD         
Jordan Young Institute Recruiting
Virginia Beach, Virginia, United States, 23462
Contact: Carolyn Battaglia, CCRC    757-490-4802    cbattaglia@jordan-younginstitute.com   
Principal Investigator: Kevin Bonner, MD         
United States, Washington
Madigan Army Medical Center Recruiting
Tacoma, Washington, United States, 98431
Contact: Britton Dennis    253-968-6590    britton.d.dennis.ctr@mail.mil   
Principal Investigator: Joanna Branstetter, MD         
United States, Wisconsin
Aurora Baycare Medical Center Recruiting
Green Bay, Wisconsin, United States, 54308
Contact: Taylor McGinnis    920-288-3127    taylor.mcginnis@aurora.org   
Principal Investigator: Jon Henry, MD         
Dean Clinic Recruiting
Madison, Wisconsin, United States, 53715
Contact: Marjorie Walrath, MSN, RN    608-260-2900    marjorie.walrath@deancare.com   
Principal Investigator: Timothy Docter, MD         
Sponsors and Collaborators
Zimmer Orthobiologics, Inc.
  More Information

No publications provided

Responsible Party: Zimmer Orthobiologics, Inc.
ClinicalTrials.gov Identifier: NCT01329445     History of Changes
Other Study ID Numbers: CSU2010-22B
Study First Received: April 1, 2011
Last Updated: October 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Zimmer Orthobiologics, Inc.:
Cartilage repair
Articular cartilage defects

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

ClinicalTrials.gov processed this record on April 17, 2014