Total Hip Prosthesis Assisted by Computer (NAVEOS)

May 11, 2026 updated by: University Hospital, Bordeaux

Total Hip Prosthesis Assisted by Computer Based on Pre-operative EOS Imaging

Computer assistance in prosthetic hip surgery is able to improve the accuracy of the surgery: Associating hip navigation and EOSTM imaging pre-operatively could simplify the procedure of hip navigation in lateral decubitus while maintaining the accuracy of the technique

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hip navigation based on preoperative EOS(TM) imaging could help to improve the accuracy of cup positioning like other computer assisted hip surgery, but it would also simplify the procedure in lateral decubitus. Indeed, the registration of the controlateral antero superior iliac spine and the pubis is not necessary with this technique. The target population of the study is the one affected with primitive hip osteoarthritis for which an indication of prosthesis of total hip has been chosen Expected Result: Simplification of the procedure of navigation of the cup. Decrease in the number of cups positioned out of the "security zone" compared to the standard manual technique of cup positioning. A result of 50% of good positioning is expected with the manual technique versus 80% with the technique of navigation based on EOS(TM).

MAIN OBJECTIVE: Compare the surgical treatment of total hip prosthesis without assistance by computer and total hip prosthesis with navigation based on imaging EOSTM pre-operative Comparative clinical trial of superiority, randomized in single blind, in 2 parallel groups: -Group 1: Installation of hip prosthesis without assistance by computer -Group 2: Installation of hip prosthesis with assistance by computer based on imaging EOS(TM)

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

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
    • Bordeaux
      • Bordeaux, Bordeaux, France, 33000
        • Unité d'orthopédie-traumatologie, membre supérieur CHU Pellegrin

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

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Nosologic criteria :
  • Primitive clinic hip osteoarthrosis
  • secondary secondary clinic hip osteoarthrosis : osteonecrosis of femoral head posttraumatic
  • Primitive radiological hip osteoarthrosis,
  • Indication of total hip prosthesis
  • Free informed and written consent, dated and signed by the patient and the investigator before any examination required by the research
  • Subject affiliated or beneficiary of the social security
  • Man or woman aged from 40 to 90 years

Exclusion Criteria:

  • The navigation based on EOSTM imaging. requires the visualization on the EOSTM. pre-operative radiography of 6 radiological bone markers. The non-viewing of these markers is a criterion for exclusion of the study.
  • anaesthetic contraindication
  • pregnant women
  • Persons under the control of justice

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment 1
Reference group, installation of hip prothesis following standard procedure
Procedure: Prosthetic hip surgery, operated under manual control
: Hip replacement is performed in supine side position. Cup is positioned under manual control with the aid of a manual ancillary.
Active Comparator: Treatment 2
:treatment group,installation of hip prosthesis with assistance by computer based on imaging EOS
Procedure: Prosthetic hip surgery operated under navigation based on EOS imaging
The patient will be installed in supine side position. The cup will be navigated with the technique based on EOS imaging. This technique requires the registration of the homolateral antero superior iliac spine and the homolateral postero superior iliac spine only. It does not require the registration of the pubis or any other controlateral points which are poorly accessible in the supine side position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Positioning of the cup in the 'security zone'. Comparison performed in immediate post-operative
Time Frame: The measure of the positioning of the cup will be carried out on the control scanner post-operatively at 3 months
The measure of the positioning of the cup will be carried out on the control scanner post-operatively at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative dislocation
Time Frame: at 1 year of the occurrence of at least 1 episode of dislocation post-operatively
propotion of Post-operative dislocation : Comparison at 1 year of the occurrence of at least 1 episode of dislocation post-operatively
at 1 year of the occurrence of at least 1 episode of dislocation post-operatively
Functional Score of Harris and the score PMA
Time Frame: at 3 month,6 month, and 12 months
mean of Functional Score of Harris and the score PMA
at 3 month,6 month, and 12 months
Quality of live score
Time Frame: at 3 month,6 month,and 12 months
. Quality of live score: Womac score, SF12,Oxford Score: comparison at 3 month,6 month,one year Measure : expressed as a mean
at 3 month,6 month,and 12 months
Early sign of radiographic unsealing
Time Frame: comparison at one year
Early sign of radiographic unsealing : comparison at one year 2 blinded operators Measure : expressed as a mean
comparison at one year
Average surgical Time
Time Frame: at inclusion
at inclusion

Collaborators and Investigators

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

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Anselme BILLAUD, University Hospital Bordeaux, France
  • Study Chair: Anntoine BENARD, University Hospital Bordeaux, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 12, 2012

Primary Completion (Actual)

November 6, 2014

Study Completion (Actual)

November 6, 2014

Study Registration Dates

First Submitted

June 5, 2012

First Submitted That Met QC Criteria

June 5, 2012

First Posted (Estimated)

June 7, 2012

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2011/07
  • 2011-A01080-41 (Other Identifier: ANSM)

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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