NCT03478189

Brief Summary

The acetabulum fracture result from a trauma with high energy at the young adult or from a trauma of low energy at the old osteoporotic patient. Anatomic reduction is known to be necessary to give functional result to patient.However, it's technically difficult because of the pelvic bone conformation. The presence of dome impaction makes the surgery more difficult. Per operatory scanner associated to 3D navigation is proved his value-added in spinal surgery.The aim of the study is show that this association permit a technical improvement for the surgeon in the precision of fracture reduction.and restore the articular congruence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 8, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

1.3 years

First QC Date

March 19, 2018

Last Update Submit

February 4, 2020

Conditions

Acetabular FractureAcetabular Surgery

Outcome Measures

Primary Outcomes (1)

  • dome impaction reduction measurement

    dome impaction reduction measurement on scanner per operatory and post operatory

    day1

Interventions

use of O-arm surgical imagingPROCEDURE

during acetabular fracture surgery , use of O-arm surgical imaging with

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patient hospitalized in GHPSJ from april 2016 and october 2017

You may qualify if:

  • age\> 18
  • surgery for acetabular fracture within 30 days
  • with dome impaction

You may not qualify if:

  • disability of inferior limb

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Study Officials

  • Guillaume RIOUALLON, MD

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 19, 2018

First Posted

March 27, 2018

Study Start

September 8, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2019

Last Updated

February 5, 2020

Record last verified: 2020-02

Locations

FR(1)