A Safety Study on Posterior Pedicle Screw System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-28

Study Completion Date

2025-06-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Degenerative Disc Disease Trauma Injury Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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MUST MINI system

cervical posterior fixation system

Intervention Type DEVICE

Eligibility Criteria

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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.