DeNovo NT Natural Tissue Graft Stratified Knee Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Zimmer Orthobiologics, Inc.
Information provided by (Responsible Party):
Zimmer Orthobiologics, Inc. Identifier:
First received: August 8, 2012
Last updated: October 14, 2013
Last verified: October 2013

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 3000 patients over the last 5 years.

Condition Intervention Phase
Cartilage, Articular
Knee Injuries
Other: DeNovo NT, natural tissue graft
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Stratified, Post-Market Study of DeNovo NT for the Treatment of Femoral and Patellar Articular Cartilage Lesions of the Knee

Resource links provided by NLM:

Further study details as provided by Zimmer Orthobiologics, Inc.:

Primary Outcome Measures:
  • Improvement in KOOS scores [ Time Frame: Between baseline and 24 months post surgery ] [ Designated as safety issue: No ]
    Improvement in Knee Injury and Osteoarthritis Outcomes Survey (KOOS) scores

Secondary Outcome Measures:
  • X-ray Evaluation [ Time Frame: Preop, 12 months and 24 months post surgery ] [ Designated as safety issue: No ]
    X-ray evaluation of joint narrowing, and osteophyte and cyst formation

  • Incidence and time to reoperation/revision [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Mean IKDC Knee Examination grades [ Time Frame: Annually to 5 years post surgery ] [ Designated as safety issue: No ]
  • MRI Evaluation [ Time Frame: Preop, 12 Months and 24 Months post surgery ] [ Designated as safety issue: No ]
    Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score

  • Incidence of adverse events [ Time Frame: Annually to 5 years post surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 254
Study Start Date: March 2012
Estimated Study Completion Date: February 2020
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
DeNovo NT Graft
DeNovo NT Graft stratified by lesion location - femur or patella
Other: DeNovo NT, natural tissue graft
Up to 5cm2 graft of chondral lesion


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Voluntary signature of the IRB approved Informed Consent,
  2. Male or female subjects between the ages of 18 to 55 years,
  3. If female:

    • Actively practicing a contraception method and willing to continue for a minimum of 1 year postoperatively, or
    • Practicing abstinence and willing to continue for a minimum of 1 year postoperatively, or
    • Surgically sterilized, or
    • Postmenopausal.
  4. Pretreatment arthroscopic confirmation indicating one or two contained lesion(s) of the femoral condyle, trochlear groove, or patella equal to an ICRS Grade 3 or 4, or OCD lesions with healed bone base, which is non sclerotic and no loss of bone greater than 6mm measured from the surrounding subchondral plate,
  5. Has peripheral cartilage debridement to healthy cartilage that results in a lesion(s) with an area of > 1 cm2 and ≤ 5 cm2,
  6. Lesion(s) to be treated must be contained/shouldered by surrounding native cartilage > 70% of the periphery,
  7. Ligaments in the affected knee are stable,
  8. Ipsilateral knee compartment has intact menisci (or meniscectomized remnant with > 5 mm rim),
  9. The contralateral knee is asymptomatic, stable, and fully functional,
  10. Is refractory to conservative non-surgical management (e.g. hyaluronic acid injection, activity modification) or previous minimal surgical intervention (e.g., arthroscopic lavage, debridement) or ACI or marrow stimulation for this condition and is further than 3 months from either the initiation of nonsurgical management or from minimal surgical intervention or is further than 12 months from ACI or marrow stimulation,
  11. 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.
  12. Must be physically and mentally willing and able, in the Investigator's opinion at the time of enrollment, to be compliant with the protocol - including all follow-up visits, survey completion, weight-bearing restrictions, and post-operative rehabilitation.

Exclusion Criteria:

  1. Clinical and/or radiographic 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) of the ipsilateral compartment (i.e., > than ICRS Grade 2 on the opposing articular surface),
    • Has more than two clinically relevant chondral lesion(s) on the index knee,
    • Osteochondritis dissecans of the knee with significant bone loss (greater than 6 mm deep from the subchondral plate).
    • Associated damage to the underlying subchondral bone requiring bone graft,
    • Has well-defined subchondral cyst(s),
    • Has current or impending subchondral avascular necrosis,
  2. History of secondary arthropathies (i.e., sickle cell disease, hemochromatosis, or autoimmune disease),
  3. Uncontrolled diabetes,
  4. Displays a high surgical risk due to unstable cardiac and/or pulmonary disease,
  5. Has HIV or other immunodeficient state including subjects on immunosuppressant therapies, or has significant illness (metastasis of any type) that decreases the probability of survival to the 2 year endpoint,
  6. Is at substantial risk for the need of organ transplantation, such as renal insufficiency,
  7. Is pregnant or breast-feeding,
  8. Body Mass Index >35 (BMI=kg/m2),
  9. Is participating concurrently in another clinical trial, or has participated in a clinical trial within 30 days of surgery,
  10. 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,
  11. Has a neuromuscular, neurosensory, or musculoskeletal deficiency that limits the ability to perform objective functional assessment of either knee,
  12. Active joint infection or history of chronic joint infection at the surgical site,
  13. Prior total meniscectomy of either knee,
  14. Radiographically has >5 degrees of malalignment as measured from the hip, knee and ankle mechanical axis.
  15. Has received, within the past three months intra-articular hyaluronic acid therapy or cortisone injections in the index knee,
  16. Has prior tendon repair, meniscus repair, ligament repair or realignment surgery in the affected knee within the past 6 months,
  17. Failed marrow stimulation or ACI treatment performed less than 12-months before baseline,
  18. Index knee has been surgically treated for cartilage repair with OATs, mosaicplasty or osteochondral allograft,
  19. Requires concomitant procedures (i.e., anterior cruciate ligament repair, high tibial osteotomy of the affected knee) with the exception of incidental loose body removal, debridement, synovectomy and/or partial meniscectomy with remaining rim >5mm wide,
  20. Has contraindications for Magnetic Resonance Imaging (MRI),
  21. Has an allergy to Polymyxin B sulfate or Bacitracin antibiotics,
  22. Is receiving workman's compensation or currently involved in litigation relating to the index knee
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01670617

Contact: Tammy Stinson, MS 512-506-3822

United States, California
Naval Medical Center San Deigo Recruiting
San Deigo, California, United States, 92134
Contact: Ruth Baer, RN    619-532-7810   
Principal Investigator: Christopher Dewing, MD         
United States, Colorado
Colorado Orthopedic Consultants Recruiting
Aurora, Colorado, United States, 80012
Contact: Janell Baker    303-695-6060   
Principal Investigator: Stewart Weinerman, MD         
United States, Florida
Andrews Institute for Orthopaedics & Sports Medicine Recruiting
Gulf Breeze, Florida, United States, 32561
Contact: Melissa Davis   
Principal Investigator: Charles Roth, MD         
United States, Georgia
Emory Spine & Sports Medicine Center Recruiting
Atlanta, Georgia, United States, 30329
Contact: Kyle Webb   
Principal Investigator: Sameh Labib, MD         
United States, Maryland
Sinai Hospital of Baltimore Recruiting
Baltimore, Maryland, United States, 21215
Contact: MaryLou Mullen    410-601-8609   
Principal Investigator: Michael Mont, MD         
United States, Massachusetts
VA Boston Healthcare System Recruiting
Boston, Massachusetts, United States, 02130
Contact: Effie Saly   
Principal Investigator: Lorenzo Silvestri, MD         
United States, Missouri
A.T. Still University of Health Sciences Recruiting
Kirksville, Missouri, United States, 63501
Contact: Barbara Magers   
Principal Investigator: Kevin Marberry, MD         
United States, New Jersey
University Orthopaedic Associates Recruiting
Somerset, New Jersey, United States, 08873
Contact: Patricia Seuffert   
Principal Investigator: Timothy Hosea, MD         
United States, New Mexico
New Mexico Orthopaedic Consultants Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Ashley Haile   
Principal Investigator: Samuel Tabet, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Cara Garrett, PA    434-243-7778   
Principal Investigator: David Diduch, MD         
United States, Washington
Madigan Army Medical Center Recruiting
Tacoma, Washington, United States, 98431
Contact: Britton Dennis   
Principal Investigator: Joanna Branstetter, MD         
Sponsors and Collaborators
Zimmer Orthobiologics, Inc.
  More Information

Responsible Party: Zimmer Orthobiologics, Inc. Identifier: NCT01670617     History of Changes
Other Study ID Numbers: CSU2011-03B
Study First Received: August 8, 2012
Last Updated: October 14, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Knee Injuries
Wounds and Injuries
Leg Injuries processed this record on July 23, 2014