DeNovo NT Natural Tissue Graft Stratified Knee Study

Status unconfirmed · Not applicable

Conditions studied: Defect of Articular Cartilage, Knee Injuries

In brief

The purpose of this study is to evaluate the long-term relief of pain and return to function for patients receiving DeNovo NT for cartilage lesions in the knee. DeNovo NT is a marketed product and has been used in more than 7,500 patients over the last 7 years.

Key facts

Study ID

NCT01670617

Run by

Zimmer Orthobiologics, Inc.

People needed

90

Starts

2012-03-01

Expected to finish

2021-12-01

Last updated by the study team

2017-01-26

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Voluntary signature of the IRB approved Informed Consent,
• Male or female subjects between the ages of 18 to 55 years,
• If female: Actively practicing a contraception method and willing to continue for a minimum of 1 year postoperatively, practicing abstinence and willing to continue for a minimum of 1 year postoperatively, or sterile
• One or two contained lesion(s) of the femur or patella ≥ ICRS Grade 3 or OCD lesions with healed bone base with no loss of bone greater than 6mm
• Has peripheral cartilage debridement to healthy cartilage that results in at least one lesion with an area of ≥ 2 cm2 and ≤ 7.5 cm2,
• Lesion(s) to be treated must be contained/shouldered > 70% of the periphery,
• Ligaments in the affected knee are stable,
• Ipsilateral knee compartment has intact menisci
• The contralateral knee is asymptomatic, stable, and fully functional,
• Is refractory to conservative non-surgical management or minimal surgical intervention and ≥ 3 months from the start of either treatment,
• Must record a response, at the preoperative study visit, of moderate to extreme pain for any one of the KOOS Pain Scale questions, P2 through P9.
• Must be physically and mentally willing and able, in the Investigator's opinion at the time of enrollment, to be compliant with the protocol

You may not qualify if…

• Clinical disease diagnosis of the indexed affected joint that includes
• Osteoarthritis or avascular necrosis,
• Rheumatoid arthritis, or history of septic or reactive arthritis,
• Gout or a history of gout or pseudogout in the affected knee,
• Bipolar articular cartilage involvement (or kissing lesions)
• Has more than two clinically relevant chondral lesion(s) on the index knee,
• Osteochondritis dissecans of the knee with significant bone loss
• Associated damage to the underlying subchondral bone requiring bone graft,
• Has well-defined subchondral cyst(s),
• Has current or impending subchondral avascular necrosis,
• History of secondary arthropathies (i.e., sickle cell disease, hemochromatosis, or autoimmune disease),
• Uncontrolled diabetes,
• Displays a high surgical risk due to unstable cardiac and/or pulmonary disease,
• Has HIV or other immunodeficient state
• Is at substantial risk for the need of organ transplantation
• Is pregnant or breast-feeding,
• Body Mass Index >35 (BMI=kg/m2),
• Is participating concurrently in another clinical trial
• Is receiving prescription pain medication other than NSAIDs or acetaminophen for conditions unrelated to the index knee condition, chronic use of anticoagulants, or taking corticosteroids,
• Has a neuromuscular, neurosensory, or musculoskeletal deficiency that limits the ability to perform objective functional assessment of either knee,
• Active joint infection or history of chronic joint infection at the surgical site,
• Prior total meniscectomy of either knee,
• Has severe patellofemoral malalignment/maltracking or patellar instability
• Radiographically has >5 degrees of malalignment
• Has received, within the past 3 months HA or cortisone injections in knee,

Where it is running

• Kerlan Jobe Orthopaedics — Los Angeles, California, United States
• Naval Medical Center San Deigo — San Deigo, California, United States
• Colorado Orthopedic Consultants — Aurora, Colorado, United States
• Andrews Institute for Orthopaedics & Sports Medicine — Gulf Breeze, Florida, United States
• Emory Spine & Sports Medicine Center — Atlanta, Georgia, United States
• Tulane University Medical Center — New Orleans, Louisiana, United States
• Sinai Hospital of Baltimore — Baltimore, Maryland, United States
• TRIA Orthopaedic Center — Bloomington, Minnesota, United States
• Minnesota Orthopedic Sports Medicine Institute at Twin Cities Orthopedics — Edina, Minnesota, United States
• A.T. Still University of Health Sciences — Kirksville, Missouri, United States
• University Orthopaedic Associates — Somerset, New Jersey, United States
• New Mexico Orthopaedic Consultants — Albuquerque, New Mexico, United States
• Oregon Health & Science University — Portland, Oregon, United States
• San Antonio Military Medical Center — San Antonio, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• Madigan Army Medical Center — Tacoma, Washington, United States
• Ottawa Hospital — Ottawa, Ontario, Canada
• Women's College Hospital — Toronoto, Canada

Full record on ClinicalTrials.gov

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