DeNovo NT Longitudinal Data Collection (LDC) Knee Study
This study is currently recruiting participants.
Verified August 2012 by Zimmer Orthobiologics, Inc.
Sponsor:
Zimmer Orthobiologics, Inc.
Information provided by (Responsible Party):
Zimmer Orthobiologics, Inc.
ClinicalTrials.gov Identifier:
NCT01329445
First received: April 1, 2011
Last updated: August 8, 2012
Last verified: August 2012
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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: Matthew Provencher, 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, New Mexico | |
| New Mexico Orthopaedic Associates | Recruiting |
| Albuquerque, New Mexico, United States, 87106 | |
| Contact: Linda Apodaca 505-724-3236 apodacals@nmortho.net | |
| Principal Investigator: Samuel Tabet, MD | |
| United States, North Carolina | |
| OrthoCarolina Research Institute | Recruiting |
| Charlotte, North Carolina, United States, 28207 | |
| Contact: Laura Lentz 704-323-3743 laura.lentz@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 | |
| 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, Wisconsin | |
| 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: | August 8, 2012 |
| 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 June 18, 2013