A Safety Study on Posterior Pedicle Screw System

Recruiting

• Conditions: Degenerative Disc Disease; Trauma Injury; Tumor

• Registration Number: NCT05821920
• Lead Sponsor: Medacta International SA

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.

Study Timeline

• Study Start: 2021-06-28
• Status Verified: 2023-04
• Study First Submitted: 2023-04-04
• Study First Submitted QC: 2023-04-18
• Study First Posted: 2023-04-20
• Primary Completion: 2023-06-28
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-01
• Study Completion: 2025-06-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of MUST MINI system safety	24 months	collection of adverse event

Secondary Outcome Measures

Name	Time	Method
Clinical outcomes	preop, 6 weeks, 6 months, 12 months	VAS pain scale measure the pain intensity with a scale from 0 ('no pain') to 10 ('pain as bad as it could possibly be').
Cervical spine functionality	Immediate postop, 6 weeks, 12 months	Sandard functional x-ray is performed in order to measure the segmental range of motion in the lumbar spine during flexion-extension with the purpose of gathering additional data for the diagnosis of instability.
Bone fusion at index level	12 month	For each level a CT examination will be performed in order to define if bone fusion is or not. The presence or absence of bridging trabecular bone across the segment can identify is reported.

Trial Locations

Locations (1)

München Klinik Bogenhausen; 🇩🇪 München, Germany