Treatment of Acetabulum Fracture With O'ARM Surgical Imaging

September 4, 2017 updated by: Groupe Hospitalier Paris Saint Joseph

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile-de-France
      • Paris, Ile-de-France, France, 75014
        • Groupe hospitalier Paris saint Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • No exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
case
Other: use of O'ARM imaging system
use of O'ARM imaging system
control
Other: use of O'ARM imaging system
use of O'ARM imaging system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Height of incongruity
Time Frame: Day 1
Reduction of the articular surface of the acetabulum
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

June 15, 2017

Study Registration Dates

First Submitted

January 31, 2017

First Submitted That Met QC Criteria

February 1, 2017

First Posted (Estimate)

February 2, 2017

Study Record Updates

Last Update Posted (Actual)

September 6, 2017

Last Update Submitted That Met QC Criteria

September 4, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COTYLE_O'ARM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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