Total Hip Prosthesis Assisted by Computer
- Conditions
- Clinic Hip Osteoarthrosis
- Interventions
- Procedure: Prosthetic hip surgery, operated under manual controlProcedure: Prosthetic hip surgery operated under navigation based on EOS imaging
- Registration Number
- NCT01613989
- Lead Sponsor
- University Hospital, Bordeaux
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment 1 Prosthetic hip surgery, operated under manual control Reference group, installation of hip prothesis following standard procedure Treatment 2 Prosthetic hip surgery operated under navigation based on EOS imaging :treatment group,installation of hip prosthesis with assistance by computer based on imaging EOS
- Primary Outcome Measures
Name Time Method Positioning of the cup in the 'security zone'. Comparison performed in immediate post-operative The measure of the positioning of the cup will be carried out on the control scanner post-operatively at 3 months
- Secondary Outcome Measures
Name Time Method Average surgical Time at inclusion Post-operative dislocation 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
Quality of live score 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
Early sign of radiographic unsealing comparison at one year Early sign of radiographic unsealing : comparison at one year 2 blinded operators Measure : expressed as a mean
Functional Score of Harris and the score PMA at 3 month,6 month, and 12 months mean of Functional Score of Harris and the score PMA
Trial Locations
- Locations (1)
Unité d'orthopédie-traumatologie, membre supérieur CHU Pellegrin
🇫🇷Bordeaux, France