Prodisc C SK & Vivo vs. Mobi-C for Cervical Disc Disease

(SMART Trial)

Not currently recruiting at 40 trial locations

Overseen By Brooks Osburn, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centinel Spine

Must not be taking: Steroids, Immunosuppressants, Chemotherapy

Disqualifiers: Osteoporosis, Autoimmune diseases, Obesity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate post-surgery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates two new treatments, prodisc C SK and prodisc C Vivo, for individuals with symptomatic cervical disc disease (SCDD). The aim is to compare these treatments with an existing one, Mobi-C, a cervical disc prosthesis. It targets those experiencing neck pain or nerve issues from the neck to the arms, who have not found relief through treatments like physical therapy or medication. Individuals who continue to experience symptoms despite these non-surgical methods may be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity for patients to explore new treatment options that could potentially provide relief where other methods have not.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, if you are taking medications that interfere with bone or soft tissue healing, like high-dose steroids, immunosuppressants, or chemotherapy agents, you may not be eligible to participate.

What prior data suggests that these devices are safe for treating cervical disc disease?

Research has shown that prodisc C SK and prodisc C Vivo are promising treatments for cervical disc disease. Studies found that 93.9% of patients using these devices experienced significant improvement in neck function, indicating that the treatments are generally well-tolerated.

The FDA has also approved these devices for replacing two cervical discs, suggesting their safety, as the FDA requires thorough testing before approving medical devices.

Overall, the evidence indicates that prodisc C SK and prodisc C Vivo are safe for patients and have a high success rate in improving neck function. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about prodisc C SK and prodisc C Vivo for cervical disc disease because these devices represent a new generation of artificial cervical discs. Unlike traditional surgical options like fusion, which can limit neck mobility, these devices aim to maintain more natural movement between vertebrae. They offer a potential advantage in preserving the range of motion and reducing stress on adjacent discs, which might lower the risk of future surgeries. Additionally, their design allows for two-level implantation, which is a promising feature for patients with more extensive cervical disc issues.

What evidence suggests that this trial's treatments could be effective for cervical disc disease?

Research has shown that the prodisc C SK and prodisc C Vivo systems, studied in this trial, effectively treat cervical disc disease. Studies have found these devices to be highly successful for patients requiring two-level disc replacement. They have proven to be as safe and effective as other similar devices available. Additionally, the FDA has approved the prodisc C Vivo and prodisc C SK for use in two-level procedures, underscoring their reliability. In this trial, participants will receive either the prodisc C SK and/or prodisc C Vivo or the Mobi-C device, which serves as the control. Overall, these treatments offer a promising option for people with symptoms of cervical disc disease. ^{1 3 5 6 7}

Who Is on the Research Team?

James Kuras

Principal Investigator

Centinel Spine

Are You a Good Fit for This Trial?

This trial is for adults aged 18-69 with cervical disc disease causing neck pain, weakness, or numbness that hasn't improved with treatments like rest or physical therapy. It's not for those who are very overweight, have had certain spine surgeries before, smoke heavily, have osteoporosis, metal allergies, immobile spinal segments, autoimmune diseases affecting the musculoskeletal system or take medication that affects healing.

Inclusion Criteria

I have nerve pain or weakness in my neck affecting my arms or hands.

My symptoms match the findings on my imaging tests.

I have neck pain due to issues in my cervical spine at two levels between C3 and C7.

Exclusion Criteria

I have had a serious neck injury between the C3 and C7 vertebrae.

I am not on high-dose steroids, immunosuppressants, or chemotherapy drugs.

Have a Body Mass Index (BMI) > 40 kg/m2

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the two-level prodisc C SK or prodisc C Vivo device, or the two-level Mobi-C device

Immediate post-surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment, including subject questionnaires, X-rays, and neurological assessments

24 months

Regular visits as specified in the protocol

Long-term follow-up

Participants continue to be monitored for up to 5 years to assess long-term safety and effectiveness

Additional 36 months

What Are the Treatments Tested in This Trial?

Interventions

• Mobi-C Cervical Disc
• prodisc C SK
• prodisc C Vivo

Trial Overview The study compares two types of artificial cervical discs (prodisc C SK and Vivo) against a similar approved device (Mobi-C). Participants will be randomly assigned to receive one of these devices in a surgery meant to alleviate symptoms from degenerative disc conditions in the neck.

How Is the Trial Designed?

Group I: Investigational Experimental Treatment 1 Intervention

Two-level prodisc C SK and/or prodisc C Vivo

Group II: Control Active Control 1 Intervention

Two-level Mobi-C device

prodisc C SK is already approved in United States, European Union for the following indications:

Approved in United States as prodisc C SK for:

• Symptomatic cervical disc disease (SCDD)

Approved in European Union as prodisc C SK for:

• Symptomatic cervical disc disease (SCDD)

Who Is Running the Clinical Trial?

Centinel Spine

Lead Sponsor

Trials

2

Recruited

590+

Published Research Related to This Trial

Cervical arthroplasty using the Mobi-C prosthesis significantly improved clinical symptoms in patients with cervical spondylotic radiculopathy, with neck pain decreasing from an average of 4.6 to 2.0 and arm pain from 6.5 to 1.3 on the visual analogue scale after surgery.

The procedure also resulted in an increase in disc space height from 6.5 mm to 7.7 mm, while maintaining range of motion, although long-term follow-up and further studies are needed to confirm these findings and ensure proper patient selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The application of cervical arthroplasty with Mobi-C for treatment of cervical spondylotic radiculopathy]. Jin, DD., Yan, HB., Zhang, ZM., et al.[2018]

In a study of 100 patients with cervical spondylosis, the Mobi-C cervical artificial disc replacement (CADR) showed better improvements in sensory and motor function compared to anterior cervical decompression and fusion (ACDF), indicating its efficacy in restoring spinal function.

Both surgical methods had good healing outcomes with no serious complications, but CADR demonstrated advantages in recovering cervical curvature and maintaining movement, although it cannot completely replace ACDF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Case control study on Mobi-C cervical artificial disc replacement and anterior cervical decompression MC+fusion for the treatment of cervical spondylosis]. Li, SW., Tan, YL., Li, J., et al.[2019]

In a two-year study of 39 patients with a ProDisc-C cervical artificial disc replacement, significant improvements were observed in neck disability (NDI) and pain levels, with a 42.5% reduction in NDI and a 53.7% reduction in neck pain after two years.

The ProDisc-C implant not only increased the range of motion at the treated segment but also showed potential complications like artificial disc kyphosis and heterotopic ossifications, highlighting the importance of proper surgical technique and patient selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[ProDisc-C mobile replacement of an intervertebral disc. A prospective mono-centric two-year study]. Stulík, J., Kryl, J., Sebesta, P., et al.[2022]

The Mobi-C implant demonstrated a significantly lower incidence of further surgeries compared to anterior cervical disc fusion (ACDF), with only 1 out of 51 Mobi-C patients requiring re-operation versus 7 out of 48 ACDF patients.

Both Mobi-C and ACDF surgeries effectively improved clinical symptoms in patients with cervical disc degeneration, but the Mobi-C implant allowed for greater range of motion in the treated segment, indicating it may offer functional advantages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of Mobi-C for treatment of single-level cervical disc spondylosis: a randomised control trial with a minimum of five years of follow-up. Hou, Y., Nie, L., Pan, X., et al.[2022]

In a study of 42 patients undergoing cervical hybrid surgery with Mobi-C, significant improvements were observed in clinical outcomes such as the modified Japanese Orthopaedic Association (mJOA) score, Neck Disability Index (NDI), and visual analogue scale (VAS) scores post-surgery, indicating the efficacy of the intervention.

While there was some mild to moderate anterior bone loss (ABL) observed in the Mobi-C segments, no severe ABL occurred, and the changes in the flexion-extension center of rotation (FE-COR) did not negatively impact clinical outcomes, suggesting that Mobi-C is a safe option for cervical disc replacement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in the centre of rotation and the anterior bone loss of the vertebral body in Mobi-C artificial disc replacement segments after cervical hybrid surgery: a retrospective study. Ma, Y., Yu, X., Li, C., et al.[2023]

Artificial cervical disc replacement (Prodisc-C) and dynamic cervical implants provide effective clinical outcomes for cervical spondylosis, showing significant improvements in neck disability and pain scores after surgery, with no serious postoperative complications reported.

Both non-fusion techniques (Prodisc-C and dynamic cervical implants) maintain cervical motion and stability better than traditional anterior cervical discectomy and fusion (ACDF), potentially reducing the risk of degeneration in adjacent segments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical outcome of mid-term follow-up of anterior cervical non-fusion surgery versus anterior cervical discectomy and fusion for cervical spondylosis]. Guan, L., Wang, WL., Hai, Y., et al.[2018]

In a study of 164 patients who underwent single-level cervical disc replacement (CDR) with the ProDisc-C, it was found that the C4/C5 level had the highest range of motion (ROM) before surgery but lost some sagittal ROM postoperatively, while other levels gained ROM.

After surgery, there were no significant differences in ROM between the cervical levels, indicating that CDR can effectively restore motion across different segments, although the long-term impact on patients' daily lives needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of segmental cervical spine vertebral motion after prodisc-C cervical disc replacement. Park, JJ., Quirno, M., Cunningham, MR., et al.[2022]

The study of 23 patients who underwent single segmental cervical disc replacement with ProDisc-C showed significant improvements in clinical outcomes, with increased Japanese Orthopaedic Association (JOA) scores and decreased Neck Disability Index (NDI) scores after surgery.

The procedure effectively maintained cervical range of motion and increased intervertebral height, while the center of rotation (COR) shifted forward, indicating a change in biomechanics that may influence postoperative segmental motion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[LOCATION CHANGE OF ROTATION CENTER AFTER SINGLE SEGMENTAL CERVICAL DISC REPLACEMENT WITH ProDisc-C]. Lou, J., Liu, H., Rong, X., et al.[2018]

In a study of 27 patients who underwent ProDisc-C cervical arthroplasty, the procedure showed acceptable long-term clinical outcomes over a mean follow-up of 123 months, although the range of motion decreased from 8.9° to 6.6° due to heterotopic ossification in 74% of cases.

Three patients required reoperations due to adjacent segment disease, indicating that while ProDisc-C arthroplasty is effective, there are potential complications that may arise over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-level cervical arthroplasty with ProDisc-C artificial disc: 10-year follow-up results in one centre. Zhao, Y., Zhou, F., Sun, Y., et al.[2021]

Citations

1. centinelspine.com centinelspine.com/launch_prodisc_C_Vivo-SK_2lvl.php

cervical total disc replacement The prodisc C Vivo & prodisc C SK Cervical TDR system achieved the highest overall composite clinical success rate at two-levels compared to any approved ...

2. thespinemarketgroup.com thespinemarketgroup.com/2025-update-cervical-disc-prostheses-global-status-trends-which-ones-survived-whos-leading-and-what-are-the-real-options-in-2025/

(UPDATED 2025): Cervical Disc Prostheses – Global ... In addition, Centinel Spine® received two-level FDA approval for its prodisc® C Vivo and prodisc® C SK Match-the-Disc™ cervical total disc ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04012996

2-level Cervical Disc Replacement Comparing Prodisc C ... The clinical trial is to demonstrate that prodisc C SK and prodisc C Vivo are at least as safe and effective as a similar, currently marketed cervical disc ...

4. centinelspine.com centinelspine.com/prodisc_c_vivo.php

Centinel Spine prodisc C Vivo Centinel Spine continues its leadership in total disc replacement—now the only company with a cervical disc portfolio that allows matching the disc to the needs ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35325298/

ProDisc-C versus anterior cervical discectomy and fusion ... Cervical TDR with ProDisc-C is feasible, safe, and effective for treatment of SCDD in Asians. No clear non-inferiority was demonstrated between ProDisc-C and ...

6. prnewswire.com prnewswire.com/news-releases/centinel-spine-receives-two-level-fda-approval-for-prodisc-c-vivo-and-prodisc-c-sk-match-the-disc-cervical-total-disc-replacement-devices-302582526.html

Centinel Spine® Receives Two-Level FDA Approval for ... 93.9% of prodisc C Vivo and prodisc C SK patients achieved a meaningful (15 point) improvement in Neck Disability Index (NDI) vs. 90.1% for the ...

7. centinelspine.com centinelspine.com/camp_totalsolution.php?utm_source=OTW&utm_medium=socialmedia_ad&utm_campaign=TotalSolution_TotalConfidence_11-21

Centinel Spine | For prodisc® Motion-Preservation/Disc ... prodisc is a Total Disc Replacement (TDR) technology platform that offers a surgical treatment proven to maintain spinal balance and motion.