2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C
SMART
A Multi-Center, Prospective, Randomized Controlled Trial Comparing the Safety and Effectiveness of Prodisc® C SK and Prodisc® C Vivo to Mobi-C® Cervical Disc in the Treatment of Two-Level Symptomatic Cervical Disc Disease (SCDD)
1 other identifier
interventional
390
1 country
30
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2019
Longer than P75 for not_applicable
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2019
CompletedFirst Posted
Study publicly available on registry
July 9, 2019
CompletedStudy Start
First participant enrolled
August 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 13, 2028
ExpectedJuly 30, 2025
July 1, 2025
6.1 years
July 5, 2019
July 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Includes assessments such as NDI and neurological improvement.
24 months
Study Arms (2)
Investigational
EXPERIMENTALTwo-level prodisc C SK and/or prodisc C Vivo
Control
ACTIVE COMPARATORTwo-level Mobi-C device
Interventions
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).
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
You may qualify if:
- 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)
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centinel Spinelead
Study Sites (30)
Flagstaff Bone and Joint
Flagstaff, Arizona, 86001, United States
Todd Lanman, MD, Inc.
Beverly Hills, California, 90210, United States
Doctors Outpatient Center for Surgery
Los Angeles, California, 90048, United States
Sutter Health - Palo Alto Medical Foundation
Palo Alto, California, 94301, United States
Sutter Health
Sacramento, California, 95816, United States
HCA Healthcare
Lone Tree, Colorado, 80124, United States
Sky Ridge Medical Center Campus
Lone Tree, Colorado, 80124, United States
Center for Spine and Orthopedics, Scientific Education and Research Foundation
Thornton, Colorado, 80229, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
St. Vincent's Neurosurgery
Jacksonville, Florida, 32204, United States
Kennedy-White Orthopaedic Center
Sarasota, Florida, 34232, United States
University of South Florida
Tampa, Florida, 33606, United States
Florida Orthopaedic Institute
Temple Terrace, Florida, 33637, United States
Indiana Spine Group
Carmel, Indiana, 46032, United States
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, 42003, United States
Spine Institute of Louisiana
Shreveport, Louisiana, 71101, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
University Spine Center
Wayne, New Jersey, 07470, United States
NYU Langone Orthopedic Hospital
New York, New York, 10003, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Northwell Health, Lenox Hill Hospital
New York, New York, 10075, United States
Axis Neurosurgery and Spine
Williamsville, New York, 14221, United States
M3-Emerging Medical Resarch
Durham, North Carolina, 27704, United States
SVCMC Solon Medical - Northern Ohio Surgery Center
Beachwood, Ohio, 44122, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
DFW Center for Spinal Disorders
Fort Worth, Texas, 76132, United States
Texas Back Institute
Plano, Texas, 75093, United States
Texas Spine Care Center
San Antonio, Texas, 78231, United States
The Disc Replacement Center
Salt Lake City, Utah, 84088, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
James Kuras
Centinel Spine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Patient is blinded to their treatment randomization until after surgery.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2019
First Posted
July 9, 2019
Study Start
August 5, 2019
Primary Completion
August 31, 2025
Study Completion (Estimated)
May 13, 2028
Last Updated
July 30, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share