2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C
NCT ID: NCT04012996
Last Updated: 2025-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
390 participants
INTERVENTIONAL
2019-08-05
2028-05-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Investigational
Two-level prodisc C SK and/or prodisc C Vivo
prodisc C SK and/or Vivo
Subjects will be randomized in a 2:1 ratio either to the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group).
Control
Two-level Mobi-C device
Mobi-C Cervical Disc
Subjects will be randomized in a 2:1 ratio either to the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group).
Interventions
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prodisc C SK and/or Vivo
Subjects will be randomized in a 2:1 ratio either to the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group).
Mobi-C Cervical Disc
Subjects will be randomized in a 2:1 ratio either to the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group).
Eligibility Criteria
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Inclusion Criteria
2. 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:
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 to primary symptoms.
5. Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics)
Exclusion Criteria
2. Have previous trauma to the C3 to C7 levels resulting in significant bony or disco-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 (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.
6. Have known allergies to cobalt, chromium, molybdenum, titanium, nickel or polyethylene.
7. Have rheumatoid arthritis, lupus, or other autoimmune disease that affect the musculoskeletal 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, chemotherapeutic agents).
11. Have a current history of heavy smoking (more than one pack of cigarettes per day).
18 Years
69 Years
ALL
Yes
Sponsors
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Centinel Spine
INDUSTRY
Responsible Party
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Principal Investigators
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James Kuras
Role: STUDY_DIRECTOR
Centinel Spine
Locations
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Flagstaff Bone and Joint
Flagstaff, Arizona, United States
Todd Lanman, MD, Inc.
Beverly Hills, California, United States
Doctors Outpatient Center for Surgery
Los Angeles, California, United States
Sutter Health - Palo Alto Medical Foundation
Palo Alto, California, United States
Sutter Health
Sacramento, California, United States
HCA Healthcare
Lone Tree, Colorado, United States
Sky Ridge Medical Center Campus
Lone Tree, Colorado, United States
Center for Spine and Orthopedics, Scientific Education and Research Foundation
Thornton, Colorado, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
St. Vincent's Neurosurgery
Jacksonville, Florida, United States
Kennedy-White Orthopaedic Center
Sarasota, Florida, United States
University of South Florida
Tampa, 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
University of Maryland Medical Center
Baltimore, Maryland, 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
M3-Emerging Medical Resarch
Durham, North Carolina, United States
SVCMC Solon Medical - Northern Ohio Surgery Center
Beachwood, Ohio, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
DFW Center for Spinal Disorders
Fort Worth, Texas, United States
Texas Back Institute
Plano, Texas, United States
Texas Spine Care Center
San Antonio, Texas, United States
The Disc Replacement Center
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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VAL-P-0022
Identifier Type: -
Identifier Source: org_study_id
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