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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A01080-41 | Other Identifier | ANSM |
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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
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1 | Active Comparator | Reference group, installation of hip prothesis following standard procedure |
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| Treatment 2 | Active Comparator | :treatment group,installation of hip prosthesis with assistance by computer based on imaging EOS |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative dislocation | propotion of Post-operative dislocation : Comparison at 1 year of the occurrence of at least 1 episode of dislocation post-operatively | at 1 year of the occurrence of at least 1 episode of dislocation post-operatively |
| Functional Score of Harris and the score PMA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anselme BILLAUD | University Hospital Bordeaux, France | Principal Investigator |
| Anntoine BENARD | University Hospital Bordeaux, France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unité d'orthopédie-traumatologie, membre supérieur CHU Pellegrin | Bordeaux | Bordeaux | 33000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27052934 | Result | Verdier N, Billaud A, Masquefa T, Pallaro J, Fabre T, Tournier C. EOS-based cup navigation: Randomised controlled trial in 78 total hip arthroplasties. Orthop Traumatol Surg Res. 2016 Jun;102(4):417-21. doi: 10.1016/j.otsr.2016.02.006. Epub 2016 Apr 1. |
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| 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 |
|
mean of Functional Score of Harris and the score PMA |
| at 3 month,6 month, and 12 months |
| Quality of live score | . Quality of live score: Womac score, SF12,Oxford Score: comparison at 3 month,6 month,one year Measure : expressed as a mean | at 3 month,6 month,and 12 months |
| Early sign of radiographic unsealing | Early sign of radiographic unsealing : comparison at one year 2 blinded operators Measure : expressed as a mean | comparison at one year |
| Average surgical Time | at inclusion |