Clinical trial NCT05821920: A Safety Study on Posterior Pedicle Screw System
Official title: Prospective Multicentric Clinical Study to Assess Safety of MUST MINI Posterior Cervical System.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Degenerative Disc Disease
Trauma Injury
Tumor
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2023-04-20
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who will undergo a posterior cervical spine fusion with MUST MINI system and respecting the inclusion criteria will be invited to participate to the study during the preoperative visit

Brief summary: 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Assessment of MUST MINI system safety
timeFrame: 24 months
Secondary outcomes:
measure: Clinical outcomes
timeFrame: preop, 6 weeks, 6 months, 12 months
measure: Clinical outcomes
timeFrame: preop, 6 weeks, 6 months, 12 months
measure: Clinical outcomes
timeFrame: preop, 6 weeks, 6 months, 12 months
measure: Clinical outcomes
timeFrame: preop, 6 weeks, 6 months, 12 months
measure: Bone fusion at index level
timeFrame: 12 month
measure: Cervical spine functionality
timeFrame: Immediate postop, 6 weeks, 12 months
Other outcomes:
Locations:
city: München
country: Germany
facility: München Klinik Bogenhausen
Study officials:
affiliation: München Klinik Bogenhausen
name: Jens Lehmberg, Prof Med
role: PRINCIPAL_INVESTIGATOR
References: