BAGUERA®C vs. Mobi-C® Implants for Cervical Disc Disease

Recruiting at 29 trial locations

Overseen By Lauren Nevins

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Spineart USA

Must not be taking: Steroids, Immunosuppressants, Chemotherapy

Disqualifiers: Infection, Osteoporosis, Diabetes, Cancer, others

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

Compensation: Varies

Number of Visits: 2

284 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares the BAGUERA®C Cervical Disc Prosthesis to another similar device in patients with neck pain due to damaged discs. The artificial disc aims to relieve pain and restore neck movement. Patients will be monitored before and after surgery for an extended period. The BAGUERA®C Cervical Disc Prosthesis is part of a broader category of cervical disc replacements, which have been studied for their long-term outcomes and effectiveness in treating degenerative cervical disc disease.

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 high-dose steroids or certain other drugs, you may not be eligible to participate.

What data supports the effectiveness of the treatment BAGUERA®C Cervical Disc Prosthesis and Mobi-C® Cervical Disc for Cervical Disc Disease?

Research shows that both BAGUERA®C and Mobi-C® implants are effective for cervical disc replacement, with studies indicating long-term safety and mobility for BAGUERA®C over 10 years, and Mobi-C® showing effectiveness in treating cervical disc degeneration and spondylosis over at least five years. ^{1 2 3 4 5}

Is the BAGUERA®C and Mobi-C® implant generally safe for humans?

The BAGUERA®C prosthesis has been evaluated for safety over a 10-year period, and the Mobi-C® implant has been studied for safety in various trials, including a 4-year follow-up study, indicating that both implants have been assessed for long-term safety in humans. ^{2 3 4 5 6}

How does the BAGUERA®C treatment differ from other treatments for cervical disc disease?

The BAGUERA®C cervical disc prosthesis is unique because it focuses on maintaining mobility in the neck by replacing the damaged disc with an artificial one, unlike traditional treatments that may involve fusing the vertebrae together, which limits movement. This approach aims to preserve natural neck motion and reduce the risk of adjacent segment degeneration over time. ^{2 3 4 5 7}

Eligibility Criteria

This trial is for adults aged 22-69 with cervical disc disease causing neck/arm pain, weakness, or abnormal sensations. Participants must have tried non-surgical treatments without success and be fit for surgery. Exclusions include prior surgeries at the affected level, infections, severe diabetes, obesity (BMI > 40), osteoporosis/osteopenia, autoimmune diseases affecting muscles/bones, and allergies to certain metals.

Inclusion Criteria

My muscle strength has decreased by at least one level.

A decrease in height on a radiograph, CT scan, or MRI scan compared to a normal adjacent disc.

My doctor has approved me for surgery.

Exclusion Criteria

I take 5 mg or more of oral steroids every day.

Belong to a vulnerable population (e.g., prisoner, wards of the court or developmentally disabled).

You have allergies to certain metals like titanium, vanadium, aluminum, cobalt, chromium, molybdenum, or polyethylene.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Evaluation

Participants are evaluated pre-operatively to assess baseline conditions

1 week

1 visit (in-person)

Surgery

Surgical placement of the BAGUERA®C or Mobi-C® Cervical Disc

1 day

1 visit (in-person)

Post-operative Follow-up

Participants are monitored post-surgery at discharge, 6 weeks, 3, 6, 12, and 24 months, and then annually until 7 years

7 years

Multiple visits (in-person)

Treatment Details

Interventions

• BAGUERA®C Cervical Disc Prosthesis
• Mobi-C® Cervical Disc

Trial Overview The study compares two types of cervical disc prostheses: BAGUERA®C and Mobi-C®, in patients with symptomatic cervical disc disease. It's a randomized controlled trial where subjects are assigned to either device in a 2:1 ratio and followed up from surgery through seven years post-operation.

Participant Groups

Group I: BAGUERA®C Experimental Treatment 1 Intervention

surgical placement of the BAGUERA®C Cervical Disc Prosthesis

Group II: Mobi-C® Active Control 1 Intervention

surgical placement of the Mobi-C® Cervical Disc

Who Is Running the Clinical Trial?

Spineart USA

Lead Sponsor

Trials

2

Recruited

580+

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 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]

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 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. Germany pubmed.ncbi.nlm.nih.gov

Cervical disc arthroplasty with the Baguera C prosthesis: clinical and radiological results of a 10-year follow-up study. [2023]

3. China pubmed.ncbi.nlm.nih.gov

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

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Early clinical experience with the mobi-C disc prosthesis. [2022]

5. 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]

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

Two-level total disc replacement with Mobi-C cervical artificial disc versus anterior discectomy and fusion: a prospective, randomized, controlled multicenter clinical trial with 4-year follow-up results. [2022]

7. 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]