NCT03040739

Brief Summary

Acetabulum fracture are high energy trauma in young people as it can be the result of a simple fall in elder people. This fracture generates an incongruity between acetabulum and femoral head. So surgery is recognized as the best treatment even if technically difficult because of the the complexity of anatomy.Navigation is widely used in orthopaedic surgery . The aim of the study is to evaluate the effect of peroperative navigation system on reduction of the acetabulum articular surface

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 8, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2017

Completed
Last Updated

September 6, 2017

Status Verified

September 1, 2017

Enrollment Period

6 months

First QC Date

January 31, 2017

Last Update Submit

September 4, 2017

Conditions

Acetabulum Fracture

Keywords

O'ARM

Outcome Measures

Primary Outcomes (1)

  • Height of incongruity

    Reduction of the articular surface of the acetabulum

    Day 1

Study Arms (2)

case

Other: use of O'ARM imaging system

control

Other: use of O'ARM imaging system

Interventions

use of O'ARM imaging systemOTHER

use of O'ARM imaging system

casecontrol

Eligibility Criteria

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

Every patients admitted in the service of orthopaedic surgery for fracture of the cotyle

You may qualify if:

  • Age \>18 years
  • acetabulum fracture dating less than a month

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 Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2017

First Posted

February 2, 2017

Study Start

July 8, 2016

Primary Completion

January 1, 2017

Study Completion

June 15, 2017

Last Updated

September 6, 2017

Record last verified: 2017-09

Locations

FR(1)