Total Hip Prosthesis Assisted by Computer (NAVEOS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01613989
First received: June 5, 2012
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention
Clinic Hip Osteoarthrosis
Procedure: Prosthetic hip surgery, operated under manual control
Procedure: Prosthetic hip surgery operated under navigation based on EOS imaging

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Total Hip Prosthesis Assisted by Computer Based on Pre-operative EOS Imaging

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Post-operative dislocation [ Time Frame: at 1 year of the occurrence of at least 1 episode of dislocation post-operatively ] [ Designated as safety issue: No ]
    propotion of Post-operative dislocation : Comparison 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 ] [ Designated as safety issue: No ]
    mean of Functional Score of Harris and the score PMA

  • Quality of live score [ Time Frame: at 3 month,6 month,and 12 months ] [ Designated as safety issue: Yes ]
    . 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 [ Time Frame: comparison at one year ] [ Designated as safety issue: No ]
    Early sign of radiographic unsealing : comparison at one year 2 blinded operators Measure : expressed as a mean

  • Average surgical Time [ Time Frame: at inclusion ] [ Designated as safety issue: No ]

Enrollment: 78
Study Start Date: June 2012
Estimated Study Completion Date: November 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment 1
Reference group, installation of hip prothesis following standard procedure
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 2
:treatment group,installation of hip prosthesis with assistance by computer based on imaging EOS
Procedure: 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

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

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01613989

Locations
France
Unité d'orthopédie-traumatologie, membre supérieur CHU Pellegrin
CHU de Bordeaux, Bordeaux, France, 33000
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Anselme BILLAUD University Hospital Bordeaux, France
Study Chair: Anntoine BENARD University Hospital Bordeaux, France
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01613989     History of Changes
Other Study ID Numbers: CHUBX 2011/07
Study First Received: June 5, 2012
Last Updated: August 20, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Hip arthroplasty
navigation

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 30, 2014