BAGUERA®C vs. Mobi-C® Implants for Cervical Disc Disease
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.12345
Is the BAGUERA®C and Mobi-C® implant generally safe for humans?
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.23457
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative Evaluation
Participants are evaluated pre-operatively to assess baseline conditions
Surgery
Surgical placement of the BAGUERA®C or Mobi-C® Cervical Disc
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
Treatment Details
Interventions
- BAGUERA®C Cervical Disc Prosthesis
- Mobi-C® Cervical Disc
Find a Clinic Near You
Who Is Running the Clinical Trial?
Spineart USA
Lead Sponsor