A Safety Study on Posterior Pedicle Screw System (MUST MINI PMS)

Medacta

Status: Enrolling

Conditions: Degenerative Disc Disease; Trauma Injury; Tumor

Treatments: Device: MUST MINI system

Study type: Observational

Funder types: Industry

Identifiers

NCT05821920

P05.008.01

Details and patient eligibility

About

The goal of this study is to assess the MUST MINI system safety in patient who will undergo a posterior cervical spine fusion intervention. Patients will be invited to partecipate during preoperative visit and follow the postoperative visits according to the standard practice.

Full description

Patient who will undergo a posterior cervical spine fusion intervention, will be invited during preoperative visit to take part to the study.

The study is an observational multicentric study with an enrolment period of 12 months with the aim to assess the safety of MUST MINI system.

All adverse events will be collected for all study duration, classified as device and not device related. Screw failure rate is calculated considering screw loosening, breakage, lost-reduction events.

Standard radiological investigations are previewed at preoperative visit, before discharge and at 6 weeks and 12 months follow-up after surgery visits; the risk of any further exposure to radiation other than it's routine use in a diagnostic manner within the follow-up period can be excluded.

A final visit at 12 months level index fusion will be evaluated clinically as well as radiographically, with a confirmation CT scan as per standard of care. Screw placement accuracy will be evaluated during this visit.

A functional cervical x-ray is considered also during last follow-up (12 months after surgery) in order to assess cervical spine functionality.

Enrollment: 44 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.