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DeNovo NT Longitudinal Data Collection (LDC) Knee Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Zimmer Orthobiologics, Inc.
Information provided by (Responsible Party):
Zimmer Orthobiologics, Inc. Identifier:
First received: April 1, 2011
Last updated: July 21, 2015
Last verified: July 2015
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 10,000 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: 200
Study Start Date: February 2011
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2021 (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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01329445

Contact: Susan Mack
Contact: General Contact

United States, Alabama
Specialized Orthopaedic Surgery & Spine Center Terminated
Huntsville, Alabama, United States, 35802
United States, California
Naval Medical Center San Diego Enrolling by invitation
San Diego, California, United States, 92134
United States, Colorado
Colorado Orthopedic Consultants Recruiting
Aurora, Colorado, United States, 80012
Contact: Anna-Marie Locher   
Principal Investigator: Phillip Stull, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30329
Contact: Ericka Brewer   
Principal Investigator: Sameh Labib, MD         
United States, Illinois
Midwest Orthopaedics at Rush Univ Hospital Recruiting
Chicago, Illinois, United States, 60612
Contact: Kavita Ahuja   
Principal Investigator: Brian J Cole, MD         
United States, Indiana
OrthoIndy Recruiting
Greenwood, Indiana, United States, 46143
Contact: Vicki Snodgrass-Miller, CCRD    317-884-5230   
Principal Investigator: Jack Farr, MD         
United States, Maryland
Sinai Hospital of Baltimore Terminated
Baltimore, Maryland, United States, 21215
United States, New Mexico
New Mexico Orthopaedic Associates Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Natalie Munson   
Principal Investigator: Samuel Tabet, MD         
United States, North Carolina
OrthoCarolina Research Institute Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Caleb Michalek   
Contact: Caryn Thompson, CCRC   
Principal Investigator: James Fleischli, MD         
United States, Ohio
Specialized Orthopaedics & Sports Medicine Recruiting
Columbus, Ohio, United States, 43215
Contact: Kelly Noll   
Principal Investigator: R. Earl Bartley, MD         
Cleveland Clinic Sports Health Center Recruiting
Garfield Heights, Ohio, United States, 44125
Contact: Maya McCauley   
Principal Investigator: Paul Saluan, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Joe Hart, PhD   
Principal Investigator: David R Diduch, MD         
Jordan Young Institute Recruiting
Virginia Beach, Virginia, United States, 23462
Contact: Carolyn Battaglia, CCRC   
Principal Investigator: Kevin Bonner, MD         
United States, Washington
Madigan Army Medical Center Withdrawn
Tacoma, Washington, United States, 98431
United States, Wisconsin
Aurora Baycare Medical Center Recruiting
Green Bay, Wisconsin, United States, 54308
Contact: Taylor McGinnis   
Principal Investigator: Jon Henry, MD         
Dean Clinic Recruiting
Madison, Wisconsin, United States, 53715
Contact: Marjorie Walrath, MSN, RN   
Principal Investigator: Timothy Docter, MD         
Sponsors and Collaborators
Zimmer Orthobiologics, Inc.
  More Information

Responsible Party: Zimmer Orthobiologics, Inc. Identifier: NCT01329445     History of Changes
Other Study ID Numbers: CSU2010-22B 
Study First Received: April 1, 2011
Last Updated: July 21, 2015
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Osteochondritis Dissecans
Bone Diseases
Musculoskeletal Diseases
Cartilage Diseases
Connective Tissue Diseases processed this record on January 17, 2017