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TerminatedNCT02931266Updated May 6, 2023

PASS MIS® Post-market Clinical Follow-up

An observational study in Spinal Fractures, sponsored by Medicrea International. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-06.

Sponsored by Medicrea International · Observational

Why this study was terminated
Lack of inclusions
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Spinal Fractures

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03

In context

Spinal Fractures

164 studies on the registry are indexed under Spinal Fractures; 29 are open to participants now.

This study's enrollment of 5 is below the median of 130 across 57 observational studies indexed under Spinal Fractures.

Browse Spinal Fractures studies →

Lead sponsor

Medicrea International is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5 participants (actual)
Patient registry
No

Interventions

  • DevicePASS MIS®

    Posterior mini-invasive osteosynthesis

06

What researchers measure

Primary outcomes

  1. Spinal stability

    To evaluate though X-rays, the efficacy of the device to promote the stability of the instrumented segments.

    Time frame: 12 months postoperatively

  2. Spinal fusion

    Radiological assessment of bony fusion

    Time frame: 12 months postoperatively

Secondary outcomes

  1. Adverse events

    To quantify and describe adverse events

    Time frame: During surgery, 1-6 months, 12 months, 24 months postoperatively

  2. Disability

    To assess patients' disability through ODI questionnaire

    Time frame: 1-6 months, 12 months, 24 months postoperatively

  3. Patient satisfaction index

    To assess patient satisfaction after surgery using a questionnaire

    Time frame: 1-6 months, 12 months, 24 months postoperatively

  4. Pain

    To assess patient's pain using visual analogue scale

    Time frame: 1-6 months, 12 months, 24 months postoperatively

07

Study locations

1 site
  • Hopital la Timone
    Marseille, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02931266
Lead sponsor
Medicrea International
Responsible party
Sponsor
First posted
Oct 13, 2016
Start date
Sep 2016
Primary completion
Jan 2018
Completion
Jan 2018
Last update
May 6, 2023

Study contacts

Stephane Fuentes, MD
principal investigator · Hopital la Timone, Marseille

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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