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

Recruiting at 30 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two surgical implants, BAGUERA®C and Mobi-C®, for treating cervical disc disease, a condition causing neck and arm pain due to nerve issues in the spine. The research aims to determine which implant is more effective for individuals with symptoms like neck or arm pain that have not improved with other treatments. Ideal candidates for this trial are those with persistent neck or arm pain who have not found relief from therapies or medications. As an unphased trial, this study provides an opportunity to contribute to understanding which implant may offer better relief for future patients.

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 prior data suggests that these cervical disc implants are safe for treating cervical disc disease?

Research has shown that the BAGUERA®C Cervical Disc Prosthesis is safe for treating cervical disc disease. Studies have found it to be effective, with few complications over ten years. One study found no major issues with the implant, highlighting its safety. This suggests that the BAGUERA®C is well-tolerated and poses minimal risk for those considering it as a treatment option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BAGUERA®C Cervical Disc Prosthesis because it offers a new approach to treating cervical disc disease. Unlike traditional fusion surgeries, which limit neck movement, BAGUERA®C is designed to preserve motion in the neck, potentially leading to a more natural range of movement post-surgery. Additionally, this prosthesis aims to reduce wear on adjacent discs, potentially lowering the risk of future surgeries. These features could make BAGUERA®C a promising alternative to current options like the Mobi-C® implant, setting it apart in the field of cervical disc treatments.

What evidence suggests that these implants are 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 promising, with studies over 10 years demonstrating excellent safety and function with few complications. Patients in these studies experienced significant improvements in the natural curve of their necks. This prosthesis is designed to maintain neck movement while reducing pain. Overall, the BAGUERA®C is considered a reliable choice for replacing cervical discs. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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 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

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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. 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 ... In terms of sagittal balance parameters, cervical lordosis significantly improved at the final follow-up compared to preoperative values (95% CI ...

5. europepmc.org europepmc.org/article/med/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.

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 ...