Clinical trial NCT01613989: Total Hip Prosthesis Assisted by Computer
Official title: Total Hip Prosthesis Assisted by Computer Based on Pre-operative EOS Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinic Hip Osteoarthrosis
Keywords: Hip arthroplasty
navigation
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2012-06-07
Enrollment: 78
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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)

Eligibility criteria: 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

Primary outcomes:
measure: Positioning of the cup in the 'security zone'. Comparison performed in immediate post-operative
timeFrame: 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
timeFrame: at 1 year of the occurrence of at least 1 episode of dislocation post-operatively
measure: Functional Score of Harris and the score PMA
timeFrame: at 3 month,6 month, and 12 months
measure: Quality of live score
timeFrame: at 3 month,6 month,and 12 months
measure: Early sign of radiographic unsealing
timeFrame: comparison at one year
measure: Average surgical Time
timeFrame: at inclusion
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Unité d'orthopédie-traumatologie, membre supérieur CHU Pellegrin
Study officials:
affiliation: University Hospital Bordeaux, France
name: Anselme BILLAUD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Bordeaux, France
name: Anntoine BENARD
role: STUDY_CHAIR
References: