A Safety Study on Posterior Pedicle Screw System

Degenerative Disc Disease Clinical Trial

— MUST MINI PMS  

Official title:

Prospective Multicentric Clinical Study to Assess Safety of MUST MINI Posterior Cervical System.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05821920
• Other study ID #: P05.008.01
• Status: Recruiting
• Start date: June 28, 2021
• Est. completion date: June 28, 2025

Study information

• Verified date: April 2023
• Source: Medacta International SA
• Contact: Elisa Bonacina, PhD
• Phone: +41 91 696 60 60
• Email: bonacina[@]medacta.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: June 28, 2025
• Est. primary completion date: June 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Trauma Injury
• Tumor

Intervention

Device:
• MUST MINI system
cervical posterior fixation system

Locations

Country	Name	City	State
Germany	München Klinik Bogenhausen	München

Sponsors (1)

Lead Sponsor	Collaborator
Medacta International SA

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of MUST MINI system safety	collection of adverse event	24 months
Secondary	Clinical outcomes	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).	preop, 6 weeks, 6 months, 12 months
Secondary	Clinical outcomes	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	preop, 6 weeks, 6 months, 12 months
Secondary	Clinical outcomes	EQ-5D questionnaire consists of two section, descriptive and a visual analog scale to describe the own health status. The score is calculated by assigning a numerical value to each response level (i.e., 1 for "no problems", 5 for "extreme problems"/"unable to") and summing these values across the five items, resulting in a score from 5 to 25.	preop, 6 weeks, 6 months, 12 months
Secondary	Clinical outcomes	VAS pain scale measure the pain intensity with a scale from 0 ('no pain') to 10 ('pain as bad as it could possibly be').	preop, 6 weeks, 6 months, 12 months
Secondary	Bone fusion at index level	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.	12 month
Secondary	Cervical spine functionality	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.	Immediate postop, 6 weeks, 12 months