A Safety Study on Posterior Pedicle Screw System (MUST MINI PMS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Degenerative Disc Disease; Trauma Injury; Tumor
• Intervention / Treatment: Device: MUST MINI system

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.

• Study Type: Observational
• Enrollment (Estimated): 44

Contacts and Locations

• Study Contact: Name: Elisa Bonacina, PhD; Phone Number: +41 91 696 60 60; Email: bonacina@medacta.ch

Study Locations

• Germany
  • München, Germany
    • Recruiting
    • Munchen Klinik Bogenhausen
    • Contact: Jens Lehmberg, Prof Dr; Phone Number: 089/9270-2021; Email: neurochirugie@muenchen-klinik.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of MUST MINI system safety	collection of adverse event	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Medacta International SA
• Investigators: Principal Investigator: Jens Lehmberg, Prof Med, Munchen Klinik Bogenhausen

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2021
• Primary Completion (Actual): June 28, 2023
• Study Completion (Estimated): June 28, 2025

Study Registration Dates

• First Submitted: April 4, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: P05.008.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes