Clinic Hip OsteoarthrosisNAVEOSNCT01613989
Total Hip Prosthesis Assisted by Computer
A study testing Prosthetic hip surgery operated under navigation based on EOS imaging in people with Clinic Hip Osteoarthrosis, run by University Hospital, Bordeaux at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Clinic Hip Osteoarthrosis
- What is being tested?
- Prosthetic hip surgery operated under navigation based on EOS imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteFrance
- Study dates
- 12 Apr 2012to 6 Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site
Unité d'orthopédie-traumatologie, membre supérieur CHU Pellegrin
Bordeaux, Bordeaux, 33000
About this study
Official title: Total Hip Prosthesis Assisted by Computer Based on Pre-operative EOS Imaging
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
Read the 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)
- Conditions
- Clinic Hip Osteoarthrosis
- Being tested
- Prosthetic hip surgery, operated under manual control, Prosthetic hip surgery operated under navigation based on EOS imaging
- Keywords
- Hip arthroplasty, navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosthetic hip surgery, operated under manual controlProcedure or surgery
: Hip replacement is performed in supine side position. Cup is positioned under manual control with the aid of a manual ancillary.
Prosthetic hip surgery operated under navigation based on EOS imagingProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Active comparator | Reference group, installation of hip prothesis following standard procedure Receives: Procedure: Prosthetic hip surgery, operated under manual control |
| Treatment 2 | Active comparator | :treatment group,installation of hip prosthesis with assistance by computer based on imaging EOS Receives: Procedure: Prosthetic hip surgery operated under navigation based on EOS imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positioning of the cup in the 'security zone'. Comparison performed in immediate post-operative
Measured: The measure of the positioning of the cup will be carried out on the control scanner post-operatively at 3 months
Secondary outcomes (5)
Post-operative dislocation
propotion of Post-operative dislocation : Comparison at 1 year of the occurrence of at least 1 episode of dislocation post-operatively
Measured: at 1 year of the occurrence of at least 1 episode of dislocation post-operatively
Functional Score of Harris and the score PMA
mean of Functional Score of Harris and the score PMA
Measured: 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
Measured: 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
Measured: comparison at one year
Average surgical Time
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study start12 Apr 2012
- Primary completion6 Nov 2014
- Study completion6 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clinic Hip OsteoarthrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anselme BILLAUD, Principal investigator, University Hospital Bordeaux, FranceAnntoine BENARD, Study chair, University Hospital Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613989
- Sponsor's protocol ID
- CHUBX 2011/07
- Other IDs
- 2011-A01080-41
- Acronym
- NAVEOS
- Status last verified
- May 2022
- First submitted
- 5 Jun 2012
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27052934
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Hip Prosthesis Assisted by Computer Based on Pre-operative EOS Imaging
- ClinicalTrials.gov ID
- NCT01613989
- Acronym / sponsor ID
- NAVEOS / CHUBX 2011/07
- Conditions
- Clinic Hip Osteoarthrosis
- Keywords
- Hip arthroplasty, navigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 12 Apr 2012 (actual)
- Primary completion
- 6 Nov 2014 (actual)
- Study completion
- 6 Nov 2014 (actual)
- First posted
- 7 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Active comparator | Procedure: Prosthetic hip surgery, operated under manual controlReference group, installation of hip prothesis following standard procedure |
| Treatment 2 | Active comparator | Procedure: Prosthetic hip surgery operated under navigation based on EOS imaging:treatment group,installation of hip prosthesis with assistance by computer based on imaging EOS |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Treatment 1 |
| Prosthetic hip surgery operated under navigation based on EOS imagingThe 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 | Procedure or surgery | Treatment 2 |
Primary outcome
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
5 secondary outcomes
Post-operative dislocation
Time frame: 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
Quality of live score
Time frame: at 3 month,6 month,and 12 months
Early sign of radiographic unsealing
Time frame: comparison at one year
Average surgical Time
Time frame: at inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 27052934Verdier 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anselme BILLAUD principal investigator
University Hospital Bordeaux, France
Anntoine BENARD study chair
University Hospital Bordeaux, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prosthetic hip surgery operated under navigation based on EOS imaging in people with Clinic Hip Osteoarthrosis, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01613989, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.