DeNovo NT Longitudinal Data Collection (LDC) Knee Study

• ClinicalTrials.gov Identifier: NCT01329445
• Recruitment Status: Unknown
• First Posted: April 6, 2011
• Last Update Posted: January 26, 2017
• Sponsor: Zimmer Orthobiologics, Inc.
• Information provided by (Responsible Party): Zimmer Orthobiologics, Inc.

Study Description

Brief Summary:

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 or disease	Intervention/treatment
Degenerative Lesion of Articular Cartilage of Knee; Osteochondritis Dissecans	Other: DeNovo NT, Natural Tissue Graft

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 160 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Post Market, Longitudinal Data Collection Study of DeNovo NT for Articular Cartilage Defects of the Knee
• Study Start Date: February 2011
• Estimated Primary Completion Date: December 2021
• Estimated Study Completion Date: December 2021

Groups and Cohorts

Group/Cohort	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Mean scores from patient-reported clinical outcome surveys [ Time Frame: 5 years ]

Secondary Outcome Measures :

1. Incidence of reoperations and revision surgeries [ Time Frame: 5 Years ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: CSU2010-22B
• First Posted: April 6, 2011
• Last Update Posted: January 26, 2017
• Last Verified: December 2016

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