A Safety Study on Posterior Pedicle Screw System | NCT05821920

Studies
A Safety Study on Posterior Pedicle Screw System

NCT05821920

Sponsor

Medacta International SA

Status

Unknown status

Last Update Posted

May 1, 2024Actual

Enrollment

44Estimated

Phase

Not provided

Conditions

Degenerative Disc Disease
Trauma Injury
Tumor

Interventions

MUST MINI system

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 28, 2021Actual

Primary Completion Date

Jun 28, 2023Actual

Completion Date

Jun 28, 2025Estimated

First Submitted Date

Apr 4, 2023

First Submission Date that Met QC Criteria

Apr 18, 2023

First Posted Date

Apr 20, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2024

Last Update Posted Date

May 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

44Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MUST MINI system	Device	cervical posterior fixation system

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Elisa Bonacina, PhD	Contact	+41 91 696 60 60		bonacina@medacta.ch

Overall Officials

Name	Affiliation	Role
Jens Lehmberg, Prof Med	München Klinik Bogenhausen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
München Klinik Bogenhausen	Recruiting	München			Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D055959	Intervertebral Disc Degeneration
D000081084	Accidental Injuries
D009369	Neoplasms

Ancestor Terms

ID	Term
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D014947	Wounds and Injuries

Browse Leaves

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Browse Branches

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