NCT05821920

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 20, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2025

Completed
Last Updated

May 1, 2024

Status Verified

April 1, 2023

Enrollment Period

2 years

First QC Date

April 4, 2023

Last Update Submit

April 30, 2024

Conditions

Degenerative Disc DiseaseTrauma InjuryTumor

Outcome Measures

Primary Outcomes (1)

  • Assessment of MUST MINI system safety

    collection of adverse event

    24 months

Secondary Outcomes (6)

  • Clinical outcomes

    preop, 6 weeks, 6 months, 12 months

  • Clinical outcomes

    preop, 6 weeks, 6 months, 12 months

  • Clinical outcomes

    preop, 6 weeks, 6 months, 12 months

  • Clinical outcomes

    preop, 6 weeks, 6 months, 12 months

  • Bone fusion at index level

    12 month

  • +1 more secondary outcomes

Interventions

MUST MINI systemDEVICE

cervical posterior fixation system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • Patients \<18 years,
  • Patients who are pregnant or intend to become pregnant during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

München Klinik Bogenhausen

München, Germany

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc DegenerationAccidental InjuriesNeoplasms

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesWounds and Injuries

Study Officials

  • Jens Lehmberg, Prof Med

    München Klinik Bogenhausen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa Bonacina, PhD

CONTACT

+41 91 696 60 60bonacina@medacta.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2023

First Posted

April 20, 2023

Study Start

June 28, 2021

Primary Completion

June 28, 2023

Study Completion

June 28, 2025

Last Updated

May 1, 2024

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)