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Comparing two types of cervical disc replacements for neck pain relief

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)

Not applicable Interventional Centinel Spine · NCT04012996

This study is testing two new types of cervical disc replacements to see if they can help people with neck pain feel better compared to a standard device.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment390 (estimated)
Ages18 Years to 69 Years
SexAll
SponsorCentinel Spine Industry-sponsored
Locations33 sites (Flagstaff, Arizona and 32 other locations)
Trial IDNCT04012996 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multi-center, prospective, randomized, controlled comparison of two investigational cervical disc replacement devices, prodisc C SK and prodisc C Vivo, against a control device, Mobi-C, in patients suffering from symptomatic cervical disc disease (SCDD). Participants, aged 18 to 69, who have not responded to conservative treatments, will be randomly assigned to receive one of the two investigational devices or the control device. The study aims to demonstrate that the investigational devices are at least as safe and effective as the control device. Patients will be monitored for a minimum of 2 years and up to 5 years, with assessments including questionnaires, X-rays, and neurological evaluations.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 69 with radiculopathy or myelopathy due to symptomatic cervical disc disease at two contiguous levels from C3 to C7.

Not a fit: Patients with prior cervical surgeries, significant vertebral immobility, or osteoporosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could provide patients with a more effective treatment option for symptomatic cervical disc disease.

How similar studies have performed: Other studies have shown success with cervical disc replacements, indicating that this approach is supported by prior research.

Eligibility criteria

Show full inclusion / exclusion criteria 
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).

Where this trial is running

Flagstaff, Arizona and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Symptomatic Cervical Disc Diseasesymptomatic cervical disc diseaseSCDDneck painradiculopathymyelopathycervical spine painneck surgery
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.