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

Running, not enrolling · Not applicable

Conditions studied: Symptomatic Cervical Disc Disease

In brief

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).

Key facts

Study ID

NCT04012996

Run by

Centinel Spine

People needed

390

Starts

2019-08-05

Expected to finish

2028-05-13

Last updated by the study team

2025-07-30

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: accepted.

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).

Where it is running

• 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

Full record on ClinicalTrials.gov

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