Total Hip Prosthesis Assisted by Computer (NAVEOS)

University Hospital of Bordeaux

Status: Completed

Conditions: Clinic Hip Osteoarthrosis

Treatments: Procedure: Prosthetic hip surgery, operated under manual control; Procedure: Prosthetic hip surgery operated under navigation based on EOS imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT01613989

CHUBX 2011/07

Details and patient eligibility

About

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

Full 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)

Enrollment: 78 patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

78 participants in 2 patient groups

Treatment 1

Active Comparator group

Description:

Reference group, installation of hip prothesis following standard procedure

Treatment:

Procedure: Prosthetic hip surgery, operated under manual control

Treatment 2

Active Comparator group

Description:

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

Treatment:

Procedure: Prosthetic hip surgery operated under navigation based on EOS imaging