Overview

This trial is active, not recruiting.

Condition clinic hip osteoarthrosis
Treatments prosthetic hip surgery, operated under manual control, prosthetic hip surgery operated under navigation based on eos imaging
Sponsor University Hospital, Bordeaux
Start date June 2012
End date November 2013
Trial size 78 participants
Trial identifier NCT01613989, CHUBX 2011/07

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
Reference group, installation of hip prothesis following standard 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 group,installation of hip prosthesis with assistance by computer based on imaging EOS
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

Primary Outcomes

Measure
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

Measure
Post-operative dislocation
time frame: 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
Quality of live score
time frame: at 3 month,6 month,and 12 months
Early sign of radiographic unsealing
time frame: comparison at one year
Average surgical Time
time frame: at inclusion

Eligibility Criteria

Male or female participants from 40 years up to 90 years old.

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

Additional Information

Official title Total Hip Prosthesis Assisted by Computer Based on Pre-operative EOS Imaging
Principal investigator Anselme BILLAUD
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)
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by University Hospital, Bordeaux.