Hip OsteoarthritisPreHIPEOSNCT05615701
Image Quality of EOSedge for Radiographic Evaluation of Hip Implant
A study testing EOSedge imaging in people with Hip Osteoarthritis and Hip Prosthesis Infection, run by University Hospital, Montpellier at 1 site in France.
Trial summary
EOSedge is a precise, low dose imaging system that delivers full body, high-quality images covering the full set of musculoskeletal and orthopedic exams. The objective of the study is to evaluate the quality of the focused pelvis/hip X-ray images on EOSedge compared to those performed on DR (current practice) to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Osteoarthritis, Hip Prosthesis Infection
- What is being tested?
- EOSedge imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteFrance
- Study dates
- 16 Nov 2022to 5 May 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient 18 years of age or older
- Came to the imaging department to perform a preoperative assessment for hip replacement or revision
Who cannot join
- Patient under guardianship or curatorship
- Patient participating in an interventional study
- Patient unable to read and/or write
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Image Quality of the EOSedge Radiographic System Versus a Standard Digital Radiographic (DR) System for Preoperative Assessment for Hip Replacement or Revision Surgery
EOSedge is a precise, low dose imaging system that delivers full body, high-quality images covering the full set of musculoskeletal and orthopedic exams.
The objective of the study is to evaluate the quality of the focused pelvis/hip X-ray images on EOSedge compared to those performed on DR (current practice) to perform a preoperative radiographic evaluation of hip implant, A sufficient image quality on focused X-ray images performed on EOSedge would allow (1) to avoid the passage on two different radiographic systems (saving time) (2) to reduce the patient's x-ray radiation dose
- Conditions
- Hip Osteoarthritis, Hip Prosthesis Infection
- Being tested
- EOSedge imaging
- Keywords
- EOS, Radiography, Hip, Hip replacement, Image quality
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOSedge imagingDiagnostic test
Hip X-ray evaluation in an EOSedge imaging for preoperative assessment for hip replacement or revision surgery
| Study group | Role | What they receive |
|---|---|---|
| EOSedge imaging | Other | Single arm study : All subjects include in the study underwent micro-dose EOS x-ray and digital radiography for radiographic evaluation of hip implant Receives: Diagnostic Test: EOSedge imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of Image quality
Each criteria is quantitative and combined to obtain a final quantitative score :
- Perfect reproduction = 2 / Moderate reproduction = 1 / Poor or uninterpretable reproduction = 0
- Artifacts ? = no or absence of periprosthetic material = 1; YES = 0
- X-ray image acceptable ? = Fully acceptable = 2; Acceptable only under limited clinical conditions = 1; Unacceptable (indicate why) = 0; OUTOCOME = FINAL SCORE
- European C, Directorate-General for R, Innovation, Carmichael J, Moores B, Maccia C. Guide européen relatif aux critères de qualité des clichés de radiodiagnostic: Publications Office, 2000.
- Kogon PL, Lumsden R. How do you critique your radiographs? The Journal of the Canadian Chiropractic Association. 1993; 37(4):230-232.
- Cook JV, Kyriou JC, Pettet A, Fitzgerald MC, Shah K, Pablot SM. Key factors in the optimization of paediatric X-ray practice. The British journal of radiology. 2001; 74(887):1032-1040.
Measured: Day 0
Secondary outcomes (2)
Dosimetry
The X-ray exposure dose induced by standard radiography and EOSedge will be compared.
The radiation delivered to the patient during standard and EOSedge radiography will be quantified according to the dose × area product (DAP) [Gy.cm2] (dose * area product), for each exposure
Measured: Day 0
Dosimetry
The X-ray exposure dose induced by standard radiography and EOSedge will be compared.
The radiation delivered to the patient during standard and EOSedge radiography will be quantified according to the entry dose [mGy]
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start16 Nov 2022
- Primary completion5 May 2023
- Study completion5 May 2023
Why it stopped: Sufficient number of subjects included for analyzes
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 Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine c-cyteval@chu-montpellier.fr, MD, PhD, Principal investigator, Departement of Medical Imaging - Montpellier University hospital LAPEYRONIE Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615701
- Sponsor's protocol ID
- RECHMPL22_0298
- Acronym
- PreHIPEOS
- Status last verified
- Sep 2023
- First submitted
- 27 Oct 2022
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Parret C, Herman F, Cyteval C, Pastor M. EOSedge vs. standard digital radiography: image quality and dose exposure in hip-focused scanning. Arch Orthop Trauma Surg. 2024 Aug;144(8):3841-3849. doi: 10.1007/s00402-024-05478-0. Epub 2024 Aug 17.
PubMed 39153100
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
- Image Quality of the EOSedge Radiographic System Versus a Standard Digital Radiographic (DR) System for Preoperative Assessment for Hip Replacement or Revision Surgery
- ClinicalTrials.gov ID
- NCT05615701
- Acronym / sponsor ID
- PreHIPEOS / RECHMPL22_0298
- Conditions
- Hip Osteoarthritis, Hip Prosthesis Infection
- Keywords
- EOS, Radiography, Hip, Hip replacement, Image quality
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sufficient number of subjects included for analyzes
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 14 Nov 2022 (actual)
- 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.
EOSedge is a precise, low dose imaging system that delivers full body, high-quality images covering the full set of musculoskeletal and orthopedic exams.
The objective of the study is to evaluate the quality of the focused pelvis/hip X-ray images on EOSedge compared to those performed on DR (current practice) to perform a preoperative radiographic evaluation of hip implant, A sufficient image quality on focused X-ray images performed on EOSedge would allow (1) to avoid the passage on two different radiographic systems (saving time) (2) to reduce the patient's x-ray radiation dose
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EOSedge imaging | Other | Diagnostic Test: EOSedge imagingSingle arm study : All subjects include in the study underwent micro-dose EOS x-ray and digital radiography for radiographic evaluation of hip implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient 18 years of age or older
- Came to the imaging department to perform a preoperative assessment for hip replacement or revision
Key exclusion criteria (3 listed)
- Patient under guardianship or curatorship
- Patient participating in an interventional study
- Patient unable to read and/or write
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 |
|---|---|---|
| EOSedge imagingHip X-ray evaluation in an EOSedge imaging for preoperative assessment for hip replacement or revision surgery | Diagnostic test | EOSedge imaging |
Primary outcome
Score of Image quality
Time frame: Day 0
Each criteria is quantitative and combined to obtain a final quantitative score : * Perfect reproduction = 2 / Moderate reproduction = 1 / Poor or uninterpretable reproduction = 0 * Artifacts ? = no or absence of periprosthetic material = 1; YES = 0 * X-ray image acceptable ? = Fully acceptable = 2; Acceptable only under limited clinical conditions = 1; Unacceptable (indicate why) = 0; OUTOCOME = FINAL SCORE 1. European C, Directorate-General for R, Innovation, Carmichael J, Moores B, Maccia C. Guide européen relatif aux critères de qualité des clichés de radiodiagnostic: Publications Office, 2000. 2. Kogon PL, Lumsden R. How do you critique your radiographs? The Journal of the Canadian Chiropractic Association. 1993; 37(4):230-232. 3. Cook JV, Kyriou JC, Pettet A, Fitzgerald MC, Shah K, Pablot SM. Key factors in the optimization of paediatric X-ray practice. The British journal of radiology. 2001; 74(887):1032-1040.
2 secondary outcomes
Dosimetry
Time frame: Day 0
Dosimetry
Time frame: Day 0
Results and safety
The study was stopped early (reason given: Sufficient number of subjects included for analyzes). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 39153100Parret C, Herman F, Cyteval C, Pastor M. EOSedge vs. standard digital radiography: image quality and dose exposure in hip-focused scanning. Arch Orthop Trauma Surg. 2024 Aug;144(8):3841-3849. doi: 10.1007/s00402-024-05478-0. Epub 2024 Aug 17.
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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.
Catherine c-cyteval@chu-montpellier.fr, MD, PhD principal investigator
Departement of Medical Imaging - Montpellier University hospital LAPEYRONIE Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EOSedge imaging in people with Hip Osteoarthritis and Hip Prosthesis Infection, run by University Hospital, Montpellier 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 2 inclusion and 3 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: stopped early, 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 was stopped early (reason given: Sufficient number of subjects included for analyzes). Results are not available in the source record.
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?
Score of Image quality (time frame: Day 0). 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 NCT05615701, 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.