Clinical trial · Observational
A Safety Study on Posterior Pedicle Screw System
Prospective Multicentric Clinical Study to Assess Safety of MUST MINI Posterior Cervical System.
NCT05821920CI-TRIAL-00076635MUST MINI PMSunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Degenerative Disc Disease | — | UNRESOLVED | — |
| Trauma Injury | — | UNRESOLVED | — |
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MUST MINI system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Assessment of MUST MINI system safety
- timeFrame
- 24 months
- description
- collection of adverse event
Secondary outcomes (6)
- measure
- Clinical outcomes
- timeFrame
- preop, 6 weeks, 6 months, 12 months
- description
- 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).
- measure
- Clinical outcomes
- timeFrame
- preop, 6 weeks, 6 months, 12 months
- description
- NDI questionnaire. Patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. 0-4points (0-8%) no disability, 5-14points ( 10 - 28%) mild disability, 15-24points (30-48% ) moderate disability, 25-34points (50- 64%) severe disability, 35-50points (70-100%) complete disability
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.