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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new procedure for individuals with cervical degenerative disc disease (DDD), which can cause neck and arm pain. The study tests a hybrid surgery that combines two existing procedures: Mobi-C (an artificial disc replacement) and ACDF (a spinal fusion technique). The goal is to determine if this hybrid approach is more effective than the traditional two-level ACDF method. It suits those who have tried various non-surgical treatments without success and continue to experience symptoms affecting daily life. Researchers will follow participants for at least two years to assess the procedure's success. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future treatment options.

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 prior data suggests that this hybrid procedure is safe?

A previous study demonstrated that Mobi-C is a safe option for treating wear and tear in the neck's discs. Over ten years, patients who underwent this procedure experienced few serious side effects. Research shows that the Mobi-C device performs well and is easily accepted by the body for individuals with one or two problematic discs in their neck.

Long-term studies suggest that Mobi-C does not cause major issues, and most patients did not require additional surgery. The safety record for Mobi-C is strong, making it a reliable choice for many patients. While no treatment is without risk, Mobi-C has consistently proven safe and effective for those with neck disc problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Mobi-C for cervical disc degeneration because it offers a unique approach that combines Cervical Disc Arthroplasty (CDA) with Anterior Cervical Discectomy and Fusion (ACDF) in a single surgery. Unlike traditional options that typically involve either replacing the disc or fusing the vertebrae, this hybrid construct allows for motion preservation at one level while stabilizing another, potentially leading to better outcomes and quicker recovery. This innovative method could provide patients with improved neck mobility and reduced stress on adjacent spinal segments compared to standard fusion surgeries alone.

What evidence suggests that the Mobi-C hybrid construct is effective for cervical disc degeneration?

Research shows that the Mobi-C cervical disc prosthesis effectively treats worn-out discs in the neck. Studies found that over 95% of patients who underwent neck surgery with Mobi-C were "very satisfied" after seven years. Even after ten years, patients reported significant improvements in their condition. The Mobi-C treatment also resulted in fewer additional surgeries and less neck pain compared to some other treatments. These long-term results suggest that Mobi-C is a dependable choice for people with disc problems in their neck. Participants in this trial will undergo a primary hybrid surgery, combining cervical disc arthroplasty (CDA) with anterior cervical discectomy and fusion (ACDF), to evaluate the effectiveness of this approach. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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 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]

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]

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]

Citations

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pmc.ncbi.nlm.nih.gov

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Overall, greater than 95% of patients (from both groups) who underwent TDR and 88% of patients who underwent ACDF were “very satisfied” at seven years. The ...

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cervicaldisc.com

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What are the 10 year clinical results?

Overall results through 10 years were comparable to 7-year outcomes, demonstrating that CDA with Mobi-C continues to be a safe and effective surgical treatment.

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tandfonline.com

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Full article: Device profile of the Mobi-C artificial cervical disc

They concluded that Mobi-C had fewer subsequent surgical interventions, lower neck pain scores, lower incidences of adjacent segment degeneration at superior ...

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ijssurgery.com

ijssurgery.com/content/10/10

Prospective, Randomized Comparison of One-level Mobi- ...

... degenerative disc disease (DDD). Patients were randomized ... total disc replacement, Cervical Spine, anterior cervical fusion, degenerative disc disease ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1040738323000059

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Inclusion criteria usually include one or two level cervical degenerative disc disease (DDD) ... However, it is important to note that the data presented here ...