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Completed

NCT Number: NCT01613989

Total Hip Prosthesis Assisted by Computer

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

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Key information

Conditions

Clinic Hip Osteoarthrosis

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unité d'orthopédie-traumatologie, membre supérieur CHU Pellegrin

Bordeaux, 33000, France

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prosthetic hip surgery, operated under manual control

Procedure

: Hip replacement is performed in supine side position. Cup is positioned under manual control with the aid of a manual ancillary.

Prosthetic hip surgery operated under navigation based on EOS imaging

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Average surgical Time

    Time frame: at inclusion

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: NAVEOS

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 7, 2012
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.