Degenerative Disc Disease, Trauma Injury, Tumor
Conditions
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.
Interventions
DEVICEMUST MINI system
cervical posterior fixation system
Sponsors
Medacta International SA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of MUST MINI system safety | 24 months | collection of adverse event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcomes | preop, 6 weeks, 6 months, 12 months | mJOA questionnaire, a 18-point investigator-administered scale separately addresses motor dysfunction of the upper extremity (MDUE) and motor dysfunction of the lower extremity (MDLE), sensory loss of the upper extremity, and sphincter dysfunction (SD). Severe myelopathy (0-11), moderate myelopathy (12-14), mild myelopahty (15-17). |
| 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. |
| 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. |
Countries
Germany
Contacts
Primary ContactElisa Bonacina, PhD
Outcome results
None listed