Total Hip Prosthesis Assisted by Computer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-12

Study Completion Date

2014-11-06

Brief Summary

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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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Detailed Description

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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)

Conditions

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Clinic Hip Osteoarthrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Treatment 1

Reference group, installation of hip prothesis following standard procedure

Group Type ACTIVE_COMPARATOR

Prosthetic hip surgery, operated under manual control

Intervention Type PROCEDURE

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

Treatment 2

:treatment group,installation of hip prosthesis with assistance by computer based on imaging EOS

Group Type ACTIVE_COMPARATOR

Prosthetic hip surgery operated under navigation based on EOS imaging

Intervention Type 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

Interventions

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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.

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No