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

(SMART Trial)

Recruiting at 37 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

390 Participants Needed

Trial Summary

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 data supports the idea that Prodisc C SK & Vivo vs. Mobi-C for Cervical Disc Disease is an effective treatment?

The available research shows that both Prodisc C and Mobi-C are effective treatments for cervical disc disease. Studies have shown that Mobi-C is effective for treating cervical spondylotic radiculopathy and single-level cervical disc spondylosis, with positive outcomes when compared to traditional surgery methods like anterior cervical disc fusion (ACDF). Similarly, Prodisc-C has shown good long-term results in treating cervical spondylosis, with studies indicating positive clinical outcomes over a 10-year follow-up period. These findings suggest that both treatments can be effective options for managing cervical disc disease. ^{1 2 3 4 5}

What safety data exists for Prodisc C and Mobi-C in treating cervical disc disease?

The safety data for Prodisc C and Mobi-C in treating cervical disc disease includes several studies. One study analyzed segmental cervical spine vertebral motion after Prodisc-C replacement, indicating it was part of an FDA trial. Another study presented a two-year follow-up on patients with a mobile ProDisc-C implant, suggesting it as an alternative to cervical spine fusion. Additionally, a study evaluated the effectiveness of single segmental cervical disc replacement with ProDisc-C, focusing on changes in the center of rotation. For Mobi-C, a study examined its use in cervical hybrid surgery, observing changes in the center of rotation and anterior bone loss. Another study investigated the clinical effectiveness of Mobi-C for cervical spondylotic radiculopathy. These studies provide insights into the safety and efficacy of these treatments. ^{1 3 6 7 8}

Is the treatment Prodisc C SK, Prodisc C Vivo a promising treatment for Cervical Disc Disease?

Yes, Prodisc C SK and Prodisc C Vivo are promising treatments for Cervical Disc Disease. They are designed to replace damaged discs in the neck, helping to maintain movement and reduce pain, which can improve the quality of life for patients. ^{1 2 3 6 9}

What is the purpose of this trial?

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).

Research Team

James Kuras

Principal Investigator

Centinel Spine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

References

1. China pubmed.ncbi.nlm.nih.gov

[The application of cervical arthroplasty with Mobi-C for treatment of cervical spondylotic radiculopathy]. [2018]

2. England 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. [2022]

3. Germany 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. [2023]

4. China 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]. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

Single-level cervical arthroplasty with ProDisc-C artificial disc: 10-year follow-up results in one centre. [2021]

6. Czech Republic pubmed.ncbi.nlm.nih.gov

[ProDisc-C mobile replacement of an intervertebral disc. A prospective mono-centric two-year study]. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Analysis of segmental cervical spine vertebral motion after prodisc-C cervical disc replacement. [2022]

8. China pubmed.ncbi.nlm.nih.gov

[LOCATION CHANGE OF ROTATION CENTER AFTER SINGLE SEGMENTAL CERVICAL DISC REPLACEMENT WITH ProDisc-C]. [2018]

9. China 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]. [2019]