BAGUERA®C vs Mobi-C for Cervical Disc Disease

Recruiting at 28 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: 13

300 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new neck disc replacement device called BAGUERA®C on patients with neck disc problems. The device aims to replace damaged discs, helping to restore normal movement and reduce pain.

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, such as high-dose steroids or certain immunosuppressants, 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 the BAGUERA®C prosthesis has been evaluated for safety and mobility over 10 years, and the Mobi-C prosthesis has been studied for its effectiveness in treating cervical disc issues, showing positive clinical results. ^{1 2 3 4 5}

Is the BAGUERA®C or Mobi-C cervical disc prosthesis safe for humans?

The BAGUERA®C prosthesis has been evaluated for safety over a 10-year period, and the Mobi-C prosthesis has been studied for safety in both single-level and two-level cervical disc replacements with follow-ups of up to five years, indicating they are generally safe for human use. ^{1 2 3 6 7}

What makes the BAGUERA®C treatment unique 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, which can help preserve natural movement and reduce long-term complications compared to traditional fusion surgery. ^{1 2 3 4 5}

Eligibility Criteria

Adults aged 22-69 with cervical disc disease at two levels from C3 to C7, experiencing neck or arm pain and other symptoms despite non-operative treatment. Must have certain radiographic signs of degeneration or herniation, be medically cleared for surgery, and able to follow the study protocol. Excludes those with severe bone diseases, prior cervical surgeries, infections, certain allergies, autoimmune diseases affecting musculoskeletal system, obesity (BMI > 40), heavy nicotine use or substance abuse.

Inclusion Criteria

I have neck or arm pain, weakness, unusual sensations, or reflex problems due to a spine condition.

- NDI Score of ≥ 30% (raw score of ≥15/50).

I am between 22 and 69 years old and fully grown.

Exclusion Criteria

My severe back pain is due to facet joint problems confirmed by tests.

I have had a serious neck injury between the C3 and C7 vertebrae.

Severe Obesity, as defined by National Institutes of Health (NIH) Clinical Guidelines Body Mass Index (BMI) > 40).

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 and Initial Recovery

Surgical placement of the cervical disc prosthesis and initial recovery

1 week

1 visit (in-person)

Post-operative Follow-up

Participants are monitored at 6 weeks, 3, 6, 12, and 24 months post-surgery

24 months

6 visits (in-person)

Long-term Follow-up

Annual follow-up visits to monitor long-term outcomes up to 7 years post-surgery

5 years

5 visits (in-person)

Treatment Details

Interventions

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

Trial Overview The trial is comparing BAGUERA®C Cervical Disc Prosthesis with Mobi-C® Cervical Disc in treating symptomatic cervical disc disease. Participants are randomly assigned in a 2:1 ratio to either the investigational device (BAGUERA®C) or control device (Mobi-C®). They will be monitored from pre-surgery up until seven years post-surgery.

Participant Groups

Group I: BAGUERA®C Experimental Treatment 1 Intervention

surgical placement of the BAGUERA®C Cervical Disc Prosthesis at 2 contiguous levels

Group II: Mobi-C® Active Control 1 Intervention

surgical placement of the Mobi-C® Cervical Disc at 2 contiguous levels

Who Is Running the Clinical Trial?

Spineart USA

Lead Sponsor

Trials

2

Recruited

580+

Findings from Research

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]

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 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]

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]

References

1. 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]

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

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

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

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

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

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

5. 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]

6. 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]

7. 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]