2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C (SMART)
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ClinicalTrials.gov Identifier: NCT04012996 |
Recruitment Status :
Recruiting
First Posted : July 9, 2019
Last Update Posted : October 28, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Symptomatic Cervical Disc Disease | Device: prodisc C SK and/or Vivo Device: Mobi-C Cervical Disc | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 390 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | multi-center, prospective, randomized, controlled comparison |
Masking: | Single (Participant) |
Masking Description: | Patient is blinded to their treatment randomization until after surgery. |
Primary Purpose: | Treatment |
Official Title: | 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) |
Actual Study Start Date : | August 5, 2019 |
Estimated Primary Completion Date : | January 2023 |
Estimated Study Completion Date : | February 2028 |

Arm | Intervention/treatment |
---|---|
Experimental: Investigational
Two-level prodisc C SK and/or prodisc C Vivo
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Device: 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). |
Active Comparator: Control
Two-level Mobi-C device
|
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). |
- 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) [ Time Frame: 24 months ]Includes assessments such as NDI and neurological improvement.

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Ages Eligible for Study: | 18 Years to 69 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04012996
Contact: James Kuras | 484.887.8873 | j.kuras@centinelspine.com | |
Contact: Megan Jensen | m.jensen@centinelspine.com |

Study Director: | James Kuras | Centinel Spine |
Responsible Party: | Centinel Spine |
ClinicalTrials.gov Identifier: | NCT04012996 |
Other Study ID Numbers: |
VAL-P-0022 |
First Posted: | July 9, 2019 Key Record Dates |
Last Update Posted: | October 28, 2022 |
Last Verified: | October 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
symptomatic cervical disc disease SCDD neck pain radiculopathy myelopathy cervical spine pain neck surgery |
cervical surgery arm numbness hand numbness arm tingling hand tingling arm weakness |
Intervertebral Disc Displacement Intervertebral Disc Degeneration Spinal Diseases Bone Diseases Musculoskeletal Diseases Hernia Pathological Conditions, Anatomical Meloxicam Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |