DeNovo NT Longitudinal Data Collection (LDC) Knee Study
- Conditions
- Degenerative Lesion of Articular Cartilage of KneeOsteochondritis Dissecans
- Interventions
- Other: DeNovo NT, Natural Tissue Graft
- Registration Number
- NCT01329445
- Lead Sponsor
- Zimmer Orthobiologics, Inc.
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 160
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description DeNovo NT patient DeNovo NT, Natural Tissue Graft Patients who have received or who are scheduled to receive a DeNovo NT graft for repair of 1-2 knee cartilage lesions.
- Primary Outcome Measures
Name Time Method Mean scores from patient-reported clinical outcome surveys 5 years
- Secondary Outcome Measures
Name Time Method Incidence of reoperations and revision surgeries 5 Years
Trial Locations
- Locations (15)
Naval Medical Center San Diego
🇺🇸San Diego, California, United States
OrthoCarolina Research Institute
🇺🇸Charlotte, North Carolina, United States
Jordan Young Institute
🇺🇸Virginia Beach, Virginia, United States
Specialized Orthopaedic Surgery & Spine Center
🇺🇸Huntsville, Alabama, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Dean Clinic
🇺🇸Madison, Wisconsin, United States
Cleveland Clinic Sports Health Center
🇺🇸Garfield Heights, Ohio, United States
Colorado Orthopedic Consultants
🇺🇸Aurora, Colorado, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Midwest Orthopaedics at Rush Univ Hospital
🇺🇸Chicago, Illinois, United States
OrthoIndy
🇺🇸Greenwood, Indiana, United States
New Mexico Orthopaedic Associates
🇺🇸Albuquerque, New Mexico, United States
Aurora Baycare Medical Center
🇺🇸Green Bay, Wisconsin, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
Specialized Orthopaedics & Sports Medicine
🇺🇸Columbus, Ohio, United States