Mobi-C + Fusion for Cervical Disc Degeneration

Recruiting at 1 trial location

Overseen By Monica Barascout, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ZimVie

Must not be taking: Corticosteroids

Disqualifiers: Infection, Trauma, Osteoporosis, Diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

97 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking medications that interfere with bone or soft tissue healing, like long-term corticosteroids, you may need to stop them.

What data supports the effectiveness of the treatment Mobi-C for cervical disc degeneration?

Research shows that the Mobi-C implant is effective for treating cervical disc issues, such as spondylosis and radiculopathy, with studies indicating positive outcomes in both single-level and multi-level conditions. Patients have experienced improvements in symptoms and maintained spinal movement over several years. ^{1 2 3 4 5}

Is the Mobi-C implant safe for humans?

Research shows that the Mobi-C implant is generally safe for humans, with studies indicating no significant differences in adverse events (unwanted side effects) between Mobi-C and other treatments like cervical fusion. However, the quality of adverse event reporting in studies could be improved. ^{1 3 4 6 7}

How does the Mobi-C treatment differ from other treatments for cervical disc degeneration?

Mobi-C is unique because it is an artificial disc replacement that allows for more natural movement in the spine compared to traditional fusion surgery, which limits motion. This treatment is designed to maintain the range of motion in the neck, potentially reducing stress on adjacent discs and improving overall neck function. ^{1 2 3 5 8}

What is the purpose of this trial?

The study is a prospective, multi-center cohort study of patients with two-level DDD implanted with CDA adjacent to ACDF (hybrid construct). The overall success of the hybrid procedure will be compared to 2-level ACDF historical controls from the Mobi-C IDE trial. 97 patients will receive the hybrid surgery and will be followed for a minimum of 2 years.

Eligibility Criteria

This trial is for adults aged 22-69 with cervical degenerative disc disease at two levels from C3 to T1, experiencing arm pain or neurological issues with or without neck pain. Candidates must have specific spinal conditions confirmed by CT/MRI, be six weeks into symptom onset or show progressive symptoms despite non-operative treatment, and be able to follow the study protocol and attend follow-up visits within 150 miles of a treatment center.

Inclusion Criteria

I can follow the study plan and fill out necessary forms. I have given or can give my consent.

I live within 150 miles of the treatment center or have approval to participate.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo hybrid surgery with CDA and ACDF at the same time

6 weeks

In-hospital stay for surgery and initial recovery

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Regular follow-up visits for assessments and outcome measures

Long-term Follow-up

Extended monitoring for long-term outcomes and safety

Additional 12 months

Treatment Details

Interventions

• Mobi-C

Trial Overview The study tests a hybrid surgery combining one level Mobi-C (cervical disc arthroplasty) and one level fusion against historical data from traditional two-level fusion surgeries. It aims to assess the safety and effectiveness of this new approach in treating symptomatic degenerative disc disease over a minimum of two years in 97 patients.

Participant Groups

Group I: Primary Hybrid Construct Experimental Treatment 1 Intervention

Primary hybrid surgery is when patients undergo CDA and ACDF at the same time.

Who Is Running the Clinical Trial?

ZimVie

Lead Sponsor

Trials

27

Recruited

2,400+

Highridge Medical

Lead Sponsor

Trials

1

Recruited

100+

Findings from Research

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]

The Mobi-C prosthesis was successfully used in 20 patients with degenerative cervical disease, showing no perioperative complications and effective healing of all incisions.

Significant improvements were observed in cervical spinal function and quality of life, with COA scores increasing from 32.10 to 38.20, VAS scores decreasing from 5.10 to 3.20, and NDI scores improving from 39.20 to 29.40 after an average follow-up of 16.5 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preliminary clinical study on artificial cervical disc replacement by Mobi-C prosthesis]. Bao, D., Ma, Y., Chen, X., et al.[2011]

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]

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 24 patients who underwent Mobi-CⓇ total disk replacement for degenerative cervical spine disease, the procedure showed favorable short-term outcomes with significant improvements in neck and arm pain, as well as overall function, over a mean follow-up of 17.4 months.

The surgery had a low complication rate, with no serious intraoperative issues or need for revision surgery, and it resulted in a significant increase in the range of motion at the affected cervical level.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Clinical Outcome of One-level Mobi-C Total Disc Replacement in Japanese Population. Ishii, K., Isogai, N., Daimon, K., 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]

A review of nine peer-reviewed studies and five FDA summary reports found that both cervical total disk replacement and fusion have excellent safety profiles, with no significant differences in adverse event rates between the two treatments.

The analysis revealed that adverse event reporting in peer-reviewed literature is often inadequate, highlighting the need for improved documentation practices compared to the more comprehensive but less clinically applicable FDA summaries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events recording and reporting in clinical trials of cervical total disk replacement. Anderson, PA., Hart, RA.[2022]

In a study of 91 patients with contiguous two-level cervical degenerative disc disease, both hybrid surgery (HS) using Mobi-C and ROI-C and anterior cervical discectomy and fusion (ACDF) showed significant clinical improvement, but the differences in outcomes between the two methods were not statistically significant.

Hybrid surgery provided a greater range of motion compared to ACDF, suggesting it may be a beneficial alternative for selected patients, although some bone resorption and heterotopic ossification were observed post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of 2-year follow-up results of the hybrid surgery using Mobi-C combined with ROI-C and anterior cervical discectomy and fusion for the treatment of contiguous two-level cervical degenerative disc diseases. Xiong, Y., Yang, YD., Yu, X., et al.[2020]

References

1. 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]

2. China pubmed.ncbi.nlm.nih.gov

[Preliminary clinical study on artificial cervical disc replacement by Mobi-C prosthesis]. [2011]

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

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

5. Japan pubmed.ncbi.nlm.nih.gov

Preliminary Clinical Outcome of One-level Mobi-C Total Disc Replacement in Japanese Population. [2022]

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

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

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

Adverse events recording and reporting in clinical trials of cervical total disk replacement. [2022]

8. Scotland pubmed.ncbi.nlm.nih.gov

Comparison of 2-year follow-up results of the hybrid surgery using Mobi-C combined with ROI-C and anterior cervical discectomy and fusion for the treatment of contiguous two-level cervical degenerative disc diseases. [2020]