PASS MIS® Post-market Clinical Follow-up | NCT02931266

Studies
PASS MIS® Post-market Clinical Follow-up

NCT02931266

Sponsor

Medicrea International

Status

Terminated

Last Update Posted

May 6, 2023Actual

Enrollment

5Actual

Phase

Not provided

Conditions

Spinal Fractures

Interventions

PASS MIS®

Countries

France

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

May 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of inclusions

Expanded Access Info

Start Date

Sep 2016Actual

Primary Completion Date

Jan 2018Actual

Completion Date

Jan 2018Actual

First Submitted Date

Jun 27, 2016

First Submission Date that Met QC Criteria

Oct 10, 2016

First Posted Date

Oct 13, 2016Estimated

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

May 2, 2023

Last Update Posted Date

May 6, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Prospective, multicenter non comparative and observational study (post-market clinical follow-up).

Detailed Description

Patients operated with PASS MIS® manufactured by MEDICREA® INTERNATIONAL between July 2016 and July 2017.

The inclusion period will be 12 months and the follow-up 24 months

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

5Actual

Name	Type	Description	Arm Group Labels	Other Names
PASS MIS®	Device	Posterior mini-invasive osteosynthesis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Spinal stability	To evaluate though X-rays, the efficacy of the device to promote the stability of the instrumented segments.	12 months postoperatively
Spinal fusion	Radiological assessment of bony fusion	12 months postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Adverse events	To quantify and describe adverse events	During surgery, 1-6 months, 12 months, 24 months postoperatively
Disability	To assess patients' disability through ODI questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient which need to be operated to treat a fracture at the lumbar and/or thoracic spine with the PASS MIS® device from MEDICREA®
Patient > 18years
Patient with a mature skeleton
Patient able to understand the protocol and the planning visit
Patient able to complete a self-administered questionnaire
Patient who have signed the informed consent form

Exclusion Criteria:

Patient presenting other medical indication than thoracolumbar fracture
Patient unable or who refuse to sign an informed consent form
Patient unable to complete a self-administered questionnaire
Patient judged as non-compliant by the investigator or not able to come back for follow-up visits
Patient who need to receive or who received an open procedure
Patient who has been not implanted with the PASS MIS® system
Pregnant women or intending to get pregnant within the next 2 years after the surgery
Patient with contra-indications to do radiographies
Local infectious state
Allergy or intolerance to the materials, suspected or known
Any contra-indications present in the notice of the product

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

Patient suffering from thoraco-lumbar spinal fracture and receiving a posterior osteosynthesis through a mini-invasive approach

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Stephane Fuentes, MD	Hopital la Timone, Marseille	Principal Investigator

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

ID	Term
D013124	Spinal Injuries
D019567	Back Injuries
D014947	Wounds and Injuries
D050723	Fractures, Bone