Safety assessment of a new spinal screw system for cervical fusion
Prospective Multicentric Clinical Study to Assess Safety of MUST MINI Posterior Cervical System.
This study is testing a new spinal screw system to see if it's safe for people having surgery to fuse their cervical spine.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medacta International SA Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (München) |
| Trial ID | NCT05821920 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety of the MUST MINI system in patients undergoing posterior cervical spine fusion. Participants will be invited during their preoperative visit and will be monitored for adverse events throughout the study duration. The study will involve standard radiological assessments at various intervals, including preoperative, postoperative, and at 6 weeks and 12 months follow-up. The accuracy of screw placement and overall cervical spine functionality will also be evaluated at the final visit.
Who should consider this trial
Good fit: Ideal candidates include adults with degenerative disc disease or those requiring posterior fixation due to trauma or tumors, with a BMI of 35 kg/m2 or less.
Not a fit: Patients under 18 years old or those who are pregnant or planning to become pregnant during the study will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of spinal fusion procedures for patients with degenerative disc disease, trauma, or tumors.
How similar studies have performed: While this study focuses on a specific new system, similar observational studies have shown promise in assessing the safety of spinal interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * those affected by degenerative disc disease needing a posterior surgical instrumented treatment aimed at segmental fusion, * those who will undergo posterior fixation due to traumatic lesion or tumor, * Patients with BMI ≤ 35 kg/m2, * those who signed the consent form to participate to the study. Exclusion Criteria: * Patients \<18 years, * Patients who are pregnant or intend to become pregnant during the study.
Where this trial is running
München
- München Klinik Bogenhausen — München, Germany (Recruiting)
Study contacts
- Principal investigator: Jens Lehmberg, Prof Med — München Klinik Bogenhausen
- Study coordinator: Elisa Bonacina, PhD
- Email: bonacina@medacta.ch
- Phone: +41 91 696 60 60
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.