Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-01-09 @ 11:56 PM
Study NCT ID:
NCT05821920
Status:
UNKNOWN
Last Update Posted:
2024-05-01
First Post:
2023-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety Study on Posterior Pedicle Screw System
Sponsor:
Medacta International SA
Organization:
Study Overview
Official Title:
Prospective Multicentric Clinical Study to Assess Safety of MUST MINI Posterior Cervical System.
Status:
UNKNOWN
Status Verified Date:
2023-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MUST MINI PMS
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: