2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C

Last updated: October 27, 2022
Sponsor: Centinel Spine
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04012996
VAL-P-0022
  • Ages 18-69
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

A multi-center, prospective, randomized, controlled comparison of the prodisc C SK and prodisc C Vivo to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease (SCDD).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 and ≤69 years.
  2. Diagnosis of radiculopathy or myelopathy with radiculopathy of the cervical spine,with pain, paresthesias or paralysis in a specific nerve root distribution C3 throughC7, including at least one of the following:
  3. Symptomatic cervical disc disease (SCDD) at two contiguous levels from C3 to C7.
  4. Radiographically determined pathology at the level to be treated correlating toprimary symptoms.
  5. Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy,physical therapy, chiropractic care and/or analgesics)

Exclusion

Exclusion Criteria:

  1. Have more than one immobile vertebral level between C1 to C7 from any cause includingbut not limited to congenital abnormalities and osteoarthritic "spontaneous" fusions.
  2. Have previous trauma to the C3 to C7 levels resulting in significant bony ordisco-ligamentous cervical spine injury.
  3. Have had a prior cervical TDR or fusion procedure at any level.
  4. Have osteoporosis or is at increased risk of osteoporosis
  5. Have active malignancy that included a history of any invasive malignancy (exceptnon-melanoma skin cancer), unless the subject had been treated with curative intentand there had been no clinical signs or symptoms of the malignancy for at least 5years.
  6. Have known allergies to cobalt, chromium, molybdenum, titanium, nickel orpolyethylene.
  7. Have rheumatoid arthritis, lupus, or other autoimmune disease that affect themusculoskeletal system.
  8. Have concomitant conditions requiring daily, high-dose oral and/or inhaled steroids.
  9. Have a Body Mass Index (BMI) > 40 kg/m2.
  10. Taking medications known to potentially interfere with bone/soft tissue healing (e.g.,high-dose oral and/or inhaled steroids, immunosuppressant medication, chemotherapeuticagents).
  11. Have a current history of heavy smoking (more than one pack of cigarettes per day).

Study Design

Total Participants: 390
Study Start date:
August 05, 2019
Estimated Completion Date:
February 29, 2028

Study Description

The clinical trial is to demonstrate that prodisc C SK and prodisc C Vivo are at least as safe and effective as a similar, currently marketed cervical disc prosthesis to treat symptomatic cervical disc disease (SCDD) in subjects at two contiguous levels from C3 to C7 who are unresponsive to conservative management. Subjects will be randomized in a 2:1 ratio to either the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group). Subjects will be followed for at least 2 years and up to 5 years. Subjects will be required to complete subject questionnaires, have X-rays and undergo neurological assessments during the follow up visits as specified in the protocol.

Connect with a study center

  • Flagstaff Bone and Joint

    Flagstaff, Arizona 86001
    United States

    Active - Recruiting

  • Todd Lanman, MD, Inc.

    Beverly Hills, California 90210
    United States

    Active - Recruiting

  • Doctors Outpatient Center for Surgery

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • Sutter Health - Palo Alto Medical Foundation

    Palo Alto, California 94301
    United States

    Active - Recruiting

  • Sutter Health

    Sacramento, California 95816
    United States

    Active - Recruiting

  • Sky Ridge Medical Center Campus

    Lone Tree, Colorado 80124
    United States

    Active - Recruiting

  • Center for Spine and Orthopedics, Scientific Education and Research Foundation

    Thornton, Colorado 80229
    United States

    Active - Recruiting

  • Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Active - Recruiting

  • St. Vincent's Neurosurgery

    Jacksonville, Florida 32204
    United States

    Active - Recruiting

  • Kennedy-White Orthopaedic Center

    Sarasota, Florida 34232
    United States

    Active - Recruiting

  • University of South Florida

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • Florida Orthopaedic Institute

    Temple Terrace, Florida 33637
    United States

    Active - Recruiting

  • Legacy Brain and Spine

    Atlanta, Georgia 30339
    United States

    Active - Recruiting

  • Indiana Spine Group

    Carmel, Indiana 46032
    United States

    Active - Recruiting

  • Orthopaedic Institute of Western Kentucky

    Paducah, Kentucky 42003
    United States

    Active - Recruiting

  • Spine Institute of Louisiana

    Shreveport, Louisiana 71101
    United States

    Active - Recruiting

  • University of Maryland Medical Center

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • Georgetown University Hospital

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • William Beaumont Hospital

    Royal Oak, Michigan 48073
    United States

    Active - Recruiting

  • Las Vegas Neurosurgical Institute for Spine and Brain Surgery

    Las Vegas, Nevada 89117
    United States

    Site Not Available

  • University Spine Center

    Wayne, New Jersey 07470
    United States

    Site Not Available

  • Hospital for Special Surgery

    New York, New York 10021
    United States

    Active - Recruiting

  • NYU Langone Orthopedic Hospital

    New York, New York 10003
    United States

    Active - Recruiting

  • Northwell Health, Lenox Hill Hospital

    New York, New York 10075
    United States

    Active - Recruiting

  • Axis Neurosurgery and Spine

    Williamsville, New York 14221
    United States

    Active - Recruiting

  • OrthoCarolina Research Institute

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • M3-Emerging Medical Resarch

    Durham, North Carolina 27704
    United States

    Active - Recruiting

  • Beachwood Medical Center

    Beachwood, Ohio 44122
    United States

    Active - Recruiting

  • St. Vincent Charity Medical Group

    Solon, Ohio 44139
    United States

    Site Not Available

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

  • DFW Center for Spinal Disorders

    Fort Worth, Texas 76132
    United States

    Active - Recruiting

  • Texas Back Institute

    Plano, Texas 75093
    United States

    Active - Recruiting

  • Texas Spine Care Center

    San Antonio, Texas 78231
    United States

    Active - Recruiting

  • The Disc Replacement Center

    Salt Lake City, Utah 84088
    United States

    Active - Recruiting

  • Multicare Neurosurgery and Spine

    Spokane, Washington 99218
    United States

    Active - Recruiting

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