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DeNovo NT Natural Tissue Graft Stratified Knee Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Zimmer Orthobiologics, Inc.
Sponsor:
Information provided by (Responsible Party):
Zimmer Orthobiologics, Inc.
ClinicalTrials.gov Identifier:
NCT01670617
First received: August 8, 2012
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Cartilage
Cartilage, Articular
Knee Injuries
Other: DeNovo NT Graft, Natural Tissue Graft, Particulated Juvenile Articular Cartilage

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: December 2020
Estimated Primary Completion Date: December 2017 (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 Graft, Natural Tissue Graft, Particulated Juvenile Articular Cartilage
Up to 7.5 cm2 graft of chondral lesion

  Eligibility

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

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, practicing abstinence and willing to continue for a minimum of 1 year postoperatively, or sterile
  4. 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
  5. Has peripheral cartilage debridement to healthy cartilage that results in at least one lesion with an area of ≥ 2 cm2 and ≤ 7.5 cm2,
  6. Lesion(s) to be treated must be contained/shouldered > 70% of the periphery,
  7. Ligaments in the affected knee are stable,
  8. Ipsilateral knee compartment has intact menisci
  9. The contralateral knee is asymptomatic, stable, and fully functional,
  10. Is refractory to conservative non-surgical management or minimal surgical intervention and ≥ 3 months from the start of either treatment,
  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

EXCLUSION CRITERIA:

  1. 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,
  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
  6. Is at substantial risk for the need of organ transplantation
  7. Is pregnant or breast-feeding,
  8. Body Mass Index >35 (BMI=kg/m2),
  9. Is participating concurrently in another clinical trial
  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. Has severe patellofemoral malalignment/maltracking or patellar instability
  15. Radiographically has >5 degrees of malalignment
  16. Has received, within the past 3 months HA or cortisone injections in knee,
  17. Has undergone prior tendon repair, meniscus repair, ligament repair or distal realignment/osteotomy surgery in the index knee, < 6 months prior to surgery,
  18. Failed marrow stimulation or ACI treatment performed < 12-mo before baseline,
  19. Index knee has been surgically treated for cartilage repair with OATs, mosaicplasty or osteochondral allograft,
  20. Involves concomitant procedures in the affected knee with the exception of incidental loose body removal, debridement, synovectomy, retinacular release, and/or partial meniscectomy
  21. Has contraindications for Magnetic Resonance Imaging (MRI),
  22. Has an allergy to Polymyxin B sulfate or Bacitracin antibiotics,
  23. 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 ClinicalTrials.gov identifier: NCT01670617

Contacts
Contact: Tammy Stinson, MS tammy.stinson@zimmer.com

Locations
United States, California
Naval Medical Center San Deigo Recruiting
San Deigo, California, United States, 92134
Contact: Ruth Baer, RN    619-532-7810    ruth.baer.ctr@med.navy.mil   
Principal Investigator: Christopher Dewing, MD         
United States, Colorado
Colorado Orthopedic Consultants Recruiting
Aurora, Colorado, United States, 80012
Contact: Janell Baker    303-695-6060    janellbaker@cocortho.com   
Principal Investigator: Stewart Weinerman, MD         
United States, Florida
Andrews Institute for Orthopaedics & Sports Medicine Recruiting
Gulf Breeze, Florida, United States, 32561
Contact: Melissa Davis       MelissaM.Davis@bhcpns.org   
Principal Investigator: Charles Roth, MD         
United States, Georgia
Emory Spine & Sports Medicine Center Recruiting
Atlanta, Georgia, United States, 30329
Contact: Kyle Webb       kyle.webb2@emory.edu   
Principal Investigator: Sameh Labib, MD         
United States, Louisiana
Tulane University Medical Center Recruiting
New Orleans, Louisiana, United States
Contact: Carol Stell, RN       cstell@tulane.edu   
Principal Investigator: Wendell Heard, MD         
United States, Maryland
Sinai Hospital of Baltimore Recruiting
Baltimore, Maryland, United States, 21215
Contact: MaryLou Mullen    410-601-8609    mmullen@lifebridgehealth.org   
Principal Investigator: Michael Mont, MD         
United States, Minnesota
TRIA Orthopaedic Center Recruiting
Bloomington, Minnesota, United States, 55431
Contact: Kelsey Schnackenberg       kelsey.schnackenberg@tria.com   
Principal Investigator: Brad Nelson, MD         
Minnesota Orthopedic Sports Medicine Institute at Twin Cities Orthopedics Recruiting
Edina, Minnesota, United States, 55435
Contact: Becky Stone       beckystone@ocpamn.com   
Principal Investigator: Corey Wulf, MD         
United States, Missouri
A.T. Still University of Health Sciences Recruiting
Kirksville, Missouri, United States, 63501
Contact: Brianna Bellinger       bbellinger@atsu.edu   
Principal Investigator: Kevin Marberry, MD         
United States, New Jersey
University Orthopaedic Associates Recruiting
Somerset, New Jersey, United States, 08873
Contact: Patricia Seuffert       patricias@uognj.com   
Principal Investigator: Timothy Hosea, MD         
United States, New Mexico
New Mexico Orthopaedic Consultants Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Ashley Haile       HaileA@nmortho.net   
Principal Investigator: Samuel Tabet, MD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97201
Contact: Hannah Jones       rainesh@ohsu.edu   
Principal Investigator: Dennis Crawford, MD         
United States, Texas
San Antonio Military Medical Center Not yet recruiting
San Antonio, Texas, United States, 78234
Contact: Pamela Foltz       pamela.a.foltz.ctr@mail.mil   
Principal Investigator: Travis Burns, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Cara Garrett, PA    434-243-7778    cgarrett@virgina.edu   
Principal Investigator: David Diduch, MD         
United States, Washington
Madigan Army Medical Center Terminated
Tacoma, Washington, United States, 98431
Canada, Ontario
Ottawa Hospital Recruiting
Ottawa, Ontario, Canada
Contact: Kim Paquin       kpaquin@toh.on.ca   
Principal Investigator: Geoffrey Dervin, MD         
Canada
Women's College Hospital Recruiting
Toronoto, Canada, M5S 1B1
Contact: Jennie Gillis       j.gillis@utosm.com   
Principal Investigator: John Theodoropoulos, MD         
Sponsors and Collaborators
Zimmer Orthobiologics, Inc.
  More Information

Publications:
Responsible Party: Zimmer Orthobiologics, Inc.
ClinicalTrials.gov Identifier: NCT01670617     History of Changes
Other Study ID Numbers: CSU2011-03B
Study First Received: August 8, 2012
Last Updated: August 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Knee Injuries
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on November 23, 2014