BAGUERA®C vs Mobi-C for Cervical Disc Disease

Not currently 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: 13

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two devices for individuals with cervical disc disease, which can cause neck pain and nerve issues. The study evaluates the effectiveness of the BAGUERA®C Cervical Disc Prosthesis against the Mobi-C® Cervical Disc Prosthesis, both designed to replace damaged discs in the neck. Participants will have symptoms like neck and arm pain that have not improved with other treatments, and researchers will monitor them over several years to assess their response to the surgery. The trial suits those with specific neck problems affecting two levels in the cervical spine who have not undergone prior neck surgeries at those levels. As an unphased trial, it offers patients the chance to contribute to important 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, such as high-dose steroids or certain immunosuppressants, you may not be eligible to participate.

What prior data suggests that these cervical disc replacement devices are safe for treating cervical disc disease?

Research has shown that the BAGUERA®C Cervical Disc Prosthesis is safe for treating cervical disc disease. After 10 years of use, studies indicate excellent safety results with very few complications, meaning most people handle it well with minimal issues.

Initial findings also suggest that the BAGUERA®C device is a safe option for those with symptoms of cervical disc disease, as no serious problems related to the implant were observed. Overall, the BAGUERA®C appears to be a well-tolerated choice for those considering disc replacement surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the BAGUERA®C Cervical Disc Prosthesis because it offers a novel approach to treating cervical disc disease. Unlike traditional fusion surgeries, which limit neck mobility by fusing bones together, BAGUERA®C aims to preserve natural movement by replacing the damaged disc with a prosthetic one. This means patients could maintain more normal neck motion and potentially recover faster. Additionally, the prosthesis is designed for placement at two contiguous levels, which could provide broader relief for individuals suffering from multi-level disc issues.

What evidence suggests that this trial's treatments could be effective for cervical disc disease?

This trial will compare the BAGUERA®C Cervical Disc Prosthesis with the Mobi-C Cervical Disc for treating cervical disc disease. Research has shown that the BAGUERA®C Cervical Disc Prosthesis is safe and effective over 10 years, with few complications. Studies have found that patients experience significant improvement after receiving this type of cervical disc replacement. The treatment recently received FDA approval, enhancing confidence in its effectiveness. These findings suggest that the BAGUERA®C could be a promising option for individuals with cervical disc disease symptoms. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

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).

- Disc herniation on CT or MRI.

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37422768/

Cervical disc arthroplasty with the Baguera C prosthesis After 10 years, cervical arthroplasty with the Baguera C prosthesis presents excellent safety and functional results and low complications.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04520776?term=spineart%20baguera%20one&viewType=Table&rank=1

A Clinical Trial Comparing the BAGUERA C to ... The proposed investigation is a multi-center, prospective, randomized, controlled comparison of the BAGUERA ®C to the control, a similar, legally marketed ...

3. spineart.com spineart.com/wp-content/uploads/2019/05/baguerac-2y-fup_aob_2018.pdf

Clinical results of cervical disc replacement with the ... This is the first publication investigating the effectiveness of single or double-level total disc replacement (TDR) with a semi-constrained cervical disc ...

4. thespinemarketgroup.com thespinemarketgroup.com/2025-update-cervical-disc-prostheses-global-status-trends-which-ones-survived-whos-leading-and-what-are-the-real-options-in-2025/

(UPDATED 2025): Cervical Disc Prostheses – Global ... March 2024: Spineart secures FDA approval for the Baguera C® Cervical Disc. KEY DRIVERS OF THE MARKET. Growing aging population driving the ...

5. thejns.org thejns.org/spine/view/journals/j-neurosurg-spine/43/2/article-p195.xml

Long-term results of cervical disc arthroplasty: a single-center ... Cervical disc arthroplasty with the Baguera C prosthesis: clinical and radiological results of a 10-year follow-up study. Eur Spine J. 2023 ...

6. link.springer.com link.springer.com/article/10.1007/s00586-023-07833-y

Cervical disc arthroplasty with the Baguera C prosthesis After 10 years, cervical arthroplasty with the Baguera®C prosthesis presents excellent safety and functional results and low complications.

7. thespinejournalonline.com thespinejournalonline.com/article/S1529-9430(14)01257-1/fulltext

Treatment of Symptomatic Degenerative Disc Disease with ... Total disc replacement using the BagueraC® device for the treatment of symptomatic cervical degenerative disc disease is a safe procedure with a low ...