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DeNovo NT Longitudinal Data Collection (LDC) Knee Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Zimmer Orthobiologics, Inc.
ClinicalTrials.gov Identifier:
NCT01329445
First received: April 1, 2011
Last updated: January 25, 2017
Last verified: December 2016
  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 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
Time Perspective: Other
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 ]

Secondary Outcome Measures:
  • Incidence of reoperations and revision surgeries [ Time Frame: 5 Years ]

Enrollment: 160
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
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
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 ClinicalTrials.gov identifier: NCT01329445

Locations
United States, Alabama
Specialized Orthopaedic Surgery & Spine Center
Huntsville, Alabama, United States, 35802
United States, California
Naval Medical Center San Diego
San Diego, California, United States, 92134
United States, Colorado
Colorado Orthopedic Consultants
Aurora, Colorado, United States, 80012
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30329
United States, Illinois
Midwest Orthopaedics at Rush Univ Hospital
Chicago, Illinois, United States, 60612
United States, Indiana
OrthoIndy
Greenwood, Indiana, United States, 46143
United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
United States, New Mexico
New Mexico Orthopaedic Associates
Albuquerque, New Mexico, United States, 87106
United States, North Carolina
OrthoCarolina Research Institute
Charlotte, North Carolina, United States, 28207
United States, Ohio
Specialized Orthopaedics & Sports Medicine
Columbus, Ohio, United States, 43215
Cleveland Clinic Sports Health Center
Garfield Heights, Ohio, United States, 44125
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22903
Jordan Young Institute
Virginia Beach, Virginia, United States, 23462
United States, Wisconsin
Aurora Baycare Medical Center
Green Bay, Wisconsin, United States, 54308
Dean Clinic
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
Zimmer Orthobiologics, Inc.
  More Information

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: January 25, 2017

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 March 24, 2017