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Clinical Trials in the USA / NCT04012996
Active, not recruiting Not applicable

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

NCT04012996 · tracked via the Priya Life Science USA tracker
Sponsor
Centinel Spine
Phase
Not applicable
Started
2019-08-05
Last updated
2025-07-30

Condition(s) studied

Symptomatic Cervical Disc Disease

Investigational drug(s) / intervention(s)

prodisc C SK and/or VivoMobi-C Cervical Disc

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).

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

Sex
ALL
Min age
18 Years
Max age
69 Years
Healthy volunteers
Accepted
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 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: 1. 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. 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).

Primary outcome measure(s)

Trial sites (30)

FacilityCityRegionStatus
Flagstaff Bone and Joint Flagstaff Arizona
Todd Lanman, MD, Inc. Beverly Hills California
Doctors Outpatient Center for Surgery Los Angeles California
Sutter Health - Palo Alto Medical Foundation Palo Alto California
Sutter Health Sacramento California
HCA Healthcare Lone Tree Colorado
Sky Ridge Medical Center Campus Lone Tree Colorado
Center for Spine and Orthopedics, Scientific Education and Research Foundation Thornton Colorado
Georgetown University Hospital Washington D.C. District of Columbia
St. Vincent's Neurosurgery Jacksonville Florida
Kennedy-White Orthopaedic Center Sarasota Florida
University of South Florida Tampa Florida
Florida Orthopaedic Institute Temple Terrace Florida
Indiana Spine Group Carmel Indiana
Orthopaedic Institute of Western Kentucky Paducah Kentucky
Spine Institute of Louisiana Shreveport Louisiana
University of Maryland Medical Center Baltimore Maryland
William Beaumont Hospital Royal Oak Michigan
University Spine Center Wayne New Jersey
NYU Langone Orthopedic Hospital New York New York
Hospital for Special Surgery New York New York
Northwell Health, Lenox Hill Hospital New York New York
Axis Neurosurgery and Spine Williamsville New York
M3-Emerging Medical Resarch Durham North Carolina
SVCMC Solon Medical - Northern Ohio Surgery Center Beachwood Ohio
Penn State Milton S. Hershey Medical Center Hershey Pennsylvania
DFW Center for Spinal Disorders Fort Worth Texas
Texas Back Institute Plano Texas
Texas Spine Care Center San Antonio Texas
The Disc Replacement Center Salt Lake City Utah
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04012996 on ClinicalTrials.gov ↗ ← All trials in the USA