2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C
- Conditions
- Symptomatic Cervical Disc Disease
- Interventions
- Device: prodisc C SK and/or VivoDevice: Mobi-C Cervical Disc
- Registration Number
- NCT04012996
- Lead Sponsor
- Centinel Spine
- Brief 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).
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 390
- Age ≥18 and ≤69 years.
- Diagnosis of radiculopathy or myelopathy with radiculopathy of the cervical spine, with pain, paresthesias or paralysis in a specific nerve root distribution C3 through C7, including at least one of the following:
- Symptomatic cervical disc disease (SCDD) at two contiguous levels from C3 to C7.
- Radiographically determined pathology at the level to be treated correlating to primary symptoms.
- Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics)
- Have more than one immobile vertebral level between C1 to C7 from any cause including but not limited to congenital abnormalities and osteoarthritic "spontaneous" fusions.
- Have previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury.
- Have had a prior cervical TDR or fusion procedure at any level.
- Have osteoporosis or is at increased risk of osteoporosis
- Have active malignancy that included a history of any invasive malignancy (except non-melanoma skin cancer), unless the subject had been treated with curative intent and there had been no clinical signs or symptoms of the malignancy for at least 5 years.
- Have known allergies to cobalt, chromium, molybdenum, titanium, nickel or polyethylene.
- Have rheumatoid arthritis, lupus, or other autoimmune disease that affect the musculoskeletal system.
- Have concomitant conditions requiring daily, high-dose oral and/or inhaled steroids.
- Have a Body Mass Index (BMI) > 40 kg/m2.
- Taking medications known to potentially interfere with bone/soft tissue healing (e.g., high-dose oral and/or inhaled steroids, immunosuppressant medication, chemotherapeutic agents).
- Have a current history of heavy smoking (more than one pack of cigarettes per day).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Investigational prodisc C SK and/or Vivo Two-level prodisc C SK and/or prodisc C Vivo Control Mobi-C Cervical Disc Two-level Mobi-C device
- Primary Outcome Measures
Name Time Method Composite clinical success rate of the two-level prodisc C SK and prodisc C Vivo will be no worse than marketed cervical disc prosthesis (Mobi-C) 24 months Includes assessments such as NDI and neurological improvement.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (33)
Todd Lanman, MD, Inc.
🇺🇸Beverly Hills, California, United States
Flagstaff Bone and Joint
🇺🇸Flagstaff, Arizona, United States
Sutter Health - Palo Alto Medical Foundation
🇺🇸Palo Alto, California, United States
Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Sutter Health
🇺🇸Sacramento, California, United States
Sky Ridge Medical Center Campus
🇺🇸Lone Tree, Colorado, United States
Kennedy-White Orthopaedic Center
🇺🇸Sarasota, Florida, United States
St. Vincent's Neurosurgery
🇺🇸Jacksonville, Florida, United States
Florida Orthopaedic Institute
🇺🇸Temple Terrace, Florida, United States
Indiana Spine Group
🇺🇸Carmel, Indiana, United States
Orthopaedic Institute of Western Kentucky
🇺🇸Paducah, Kentucky, United States
Spine Institute of Louisiana
🇺🇸Shreveport, Louisiana, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
University Spine Center
🇺🇸Wayne, New Jersey, United States
NYU Langone Orthopedic Hospital
🇺🇸New York, New York, United States
Hospital for Special Surgery
🇺🇸New York, New York, United States
Northwell Health, Lenox Hill Hospital
🇺🇸New York, New York, United States
Axis Neurosurgery and Spine
🇺🇸Williamsville, New York, United States
Beachwood Medical Center
🇺🇸Beachwood, Ohio, United States
St. Vincent Charity Medical Group
🇺🇸Solon, Ohio, United States
DFW Center for Spinal Disorders
🇺🇸Fort Worth, Texas, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Multicare Neurosurgery and Spine
🇺🇸Spokane, Washington, United States
Doctors Outpatient Center for Surgery
🇺🇸Los Angeles, California, United States
Legacy Brain and Spine
🇺🇸Atlanta, Georgia, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Las Vegas Neurosurgical Institute for Spine and Brain Surgery
🇺🇸Las Vegas, Nevada, United States
M3-Emerging Medical Resarch
🇺🇸Durham, North Carolina, United States
Texas Spine Care Center
🇺🇸San Antonio, Texas, United States
The Disc Replacement Center
🇺🇸Salt Lake City, Utah, United States
Texas Back Institute
🇺🇸Plano, Texas, United States
Center for Spine and Orthopedics, Scientific Education and Research Foundation
🇺🇸Thornton, Colorado, United States
University of South Florida
🇺🇸Tampa, Florida, United States