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Trial Title:
A Safety Study on Posterior Pedicle Screw System
NCT ID:
NCT05821920
Condition:
Degenerative Disc Disease
Trauma Injury
Tumor
Conditions: Official terms:
Intervertebral Disc Degeneration
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
MUST MINI system
Description:
cervical posterior fixation system
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.
Criteria for eligibility:
Study pop:
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
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
München Klinik Bogenhausen
Address:
City:
München
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Jens Lehmberg, Prof Dr
Phone:
089/9270-2021
Email:
neurochirugie@muenchen-klinik.de
Start date:
June 28, 2021
Completion date:
June 28, 2025
Lead sponsor:
Agency:
Medacta International SA
Agency class:
Industry
Source:
Medacta International SA
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05821920
