Clinical trial NCT01329445: DeNovo NT Longitudinal Data Collection (LDC) Knee Study
Official title: Post Market, Longitudinal Data Collection Study of DeNovo NT for Articular Cartilage Defects of the Knee
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Degenerative Lesion of Articular Cartilage of Knee
Osteochondritis Dissecans
Keywords: Cartilage repair
Articular cartilage defects
Lead sponsor: Zimmer Orthobiologics, Inc.
Sponsor class: INDUSTRY
First posted: 2011-04-06
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients being recommended for arthroscopic or surgical intervention for articular cartilage lesionis of the knee

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.

Eligibility 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

Primary outcomes:
measure: Mean scores from patient-reported clinical outcome surveys
timeFrame: 5 years
Secondary outcomes:
measure: Incidence of reoperations and revision surgeries
timeFrame: 5 Years
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Specialized Orthopaedic Surgery & Spine Center
state: Alabama
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
city: Aurora
country: United States
facility: Colorado Orthopedic Consultants
state: Colorado
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Midwest Orthopaedics at Rush Univ Hospital
state: Illinois
city: Greenwood
country: United States
facility: OrthoIndy
state: Indiana
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Albuquerque
country: United States
facility: New Mexico Orthopaedic Associates
state: New Mexico
city: Charlotte
country: United States
facility: OrthoCarolina Research Institute
state: North Carolina
city: Columbus
country: United States
facility: Specialized Orthopaedics & Sports Medicine
state: Ohio
city: Garfield Heights
country: United States
facility: Cleveland Clinic Sports Health Center
state: Ohio
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Virginia Beach
country: United States
facility: Jordan Young Institute
state: Virginia
city: Green Bay
country: United States
facility: Aurora Baycare Medical Center
state: Wisconsin
city: Madison
country: United States
facility: Dean Clinic
state: Wisconsin
Study officials:
References: