Mobi-C + Fusion for Cervical Disc Degeneration

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: ZimVie

Must not be taking: Corticosteroids

Disqualifiers: Infection, Trauma, Osteoporosis, Diabetes, others

No Placebo Group

Trial Summary

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.

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}

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.

Trial 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 (Device)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of California-Davis Sacramento, CA

Michigan Orthopaedic Surgeons Southfield, MI

Who Is Running the Clinical Trial?

ZimVie Lead Sponsor

Highridge Medical Lead Sponsor

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] In order to evaluate the effectiveness of the Mobi-C implant in cervical disc degeneration, a randomised study was conducted, comparing the Mobi-C prosthesis arthroplasty with anterior cervical disc fusion (ACDF) in patients with single level cervical spondylosis.

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

[Preliminary clinical study on artificial cervical disc replacement by Mobi-C prosthesis]. [2011] To study the clinical application of Mobi-C prosthesis in treatment of anterior cervical discectomy and artificial disc replacement (ADR).

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] To examine the short-term efficacy and imaging results of using the Mobi-C in cervical hybrid surgery on 2-level cervical spondylolisthesis. To observe post-operative changes in the flexion-extension centre of rotation (FE-COR) and anterior bone loss (ABL) of the anterior cervical disc replacement (ACDR) segment.

4. China pubmed.ncbi.nlm.nih.gov

[The application of cervical arthroplasty with Mobi-C for treatment of cervical spondylotic radiculopathy]. [2018] To investigate the clinical effectiveness of cervical arthroplasty with Mobi-C prosthesis for treatment of cervical spondylotic radiculopathy.

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

Preliminary Clinical Outcome of One-level Mobi-C Total Disc Replacement in Japanese Population. [2022] Label="INTRODUCTION" NlmCategory="BACKGROUND">In 2018, the first Mobi-CⓇ total disk replacement (TDR) case was performed in Japan. In this study, we examined the preliminary clinical outcome of Mobi-CⓇ for degenerative cervical spine disease.

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

Analysis of segmental cervical spine vertebral motion after prodisc-C cervical disc replacement. [2022] Retrospective study of patients enrolled in a prospective randomized Food and Drug Administration trial with single level cervical disc replacement (CDR) with the ProDisc-C (Synthes, Paoli, PA).

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

Adverse events recording and reporting in clinical trials of cervical total disk replacement. [2022] Adverse events reporting in pivotal trials of new technologies, such as cervical total disk replacement, are essential to determine safety. Important questions concerning the adequacy of reporting about such new technologies in peer-reviewed publications have prompted this analysis to assess the safety of cervical disk replacement compared with fusion as presented in peer-reviewed publications and FDA summary reports. Identifying differences among these reports highlight the poor quality of adverse event reporting in the peer-reviewed literature. Nine peer-reviewed studies and five FDA summary reports documented excellent safety for both cervical fusion and disk arthroplasty. No differences in rates of adverse events were found to exist between the two treatments. The methods of recording and the actual reporting of adverse events were poor in peer-reviewed manuscripts, whereas they were comprehensive but difficult to clinically apply in the FDA summaries. Recommendations to improve documentation and reporting of adverse events are presented.

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] Although the Mobi-C artificial disc and the ROI-C cervical cage have been widely used in the treatment of cervical degenerative disc diseases (CDDD), few reports addressed the features of combined application of both devices. This study is aimed at comparing the clinical and radiological outcomes of treating contiguous two-level CDDD using Mobi-C and ROI-C combined in a hybrid surgery (HS) with anterior cervical discectomy and fusion (ACDF) using ROI-C. We reviewed ninety-one patients who underwent HS (n = 48) or ACDF (n = 43) surgery for symptomatic contiguous two-level CDDD. >2 years' clinical and radiological outcomes were reviewed and evaluated retrospectively. At the last follow-up, significant improvement in the mean VAS, JOA, and NDI scores was found both in the HS and ACDF groups (p 0.05). The global range of motion (ROM) in the HS group was significantly larger than that in the ACDF group (p