Hip FracturesHIPEOSNCT03603470
Total Hip Arthroplasty Instability and Lumbo-pelvic Kinematics: EOS Imaging Assessment of Variation in Spinal and Pelvic Parameters From Standing to Sitting
A study testing EOS imagery in people with Hip Fractures, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial summary
The authors hypothesize that a pelvic kinematic disorder, demonstrated by a significant decrease in sacral slope, is associated with the risk of instability of total hip prosthesis, the sacral slope being measured by an EOS imaging system during the transition to sitting in unstable patients versus patients with no… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hip Fractures
- What is being tested?
- EOS imagery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- 6 Jul 2018to 1 Feb 2019
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- The patient must be at least 18 years old and less than 85 years old
- Patient has a conventional first intention total hip arthroplasty (not dual mobility) by posterior approach
- "Case" patients have at least one previous episode of prosthetic dislocation repaired with surgery
- "Control" patients have no previous episode of prosthetic dislocation with more than 2 year since initial intervention
Who cannot join
- The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient is pregnant, parturient or breastfeeding
- Patient with lumbar instrumentation
Show all 12Show fewer
- Patient with severe dementia (Mini Mental State Examination < 10)
- Patient with American Society of Anesthesiologists score ≥ 4
- Patient experience multiple falls
- Patient requiring early revision surgery (<15 days postoperatively
- Patient with obvious implant positioning error on an X-ray of the pelvis.
- Patient with dislocation of traumatic origin (significant kinetic trauma)
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Lapeyronie de Montpellier
Montpellier, 34295
CHU Nimes
Nîmes, 30029
About this study
The authors hypothesize that a pelvic kinematic disorder, demonstrated by a significant decrease in sacral slope, is associated with the risk of instability of total hip prosthesis, the sacral slope being measured by an EOS imaging system during the transition to sitting in unstable patients versus patients with no history of instability.
- Conditions
- Hip Fractures
- Being tested
- EOS imagery
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOS imageryOther
Whole body EOS imaging in seated and standing position
| Study group | Role | What they receive |
|---|---|---|
| Patients with previous prothesis instability | Other | Not described Receives: Other: EOS imagery |
| Patients without prothesis instability | Other | Not described Receives: Other: EOS imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sacral slope between standing to sitting difference between groups
Sacral slope between standing to sitting difference between groups
Measured: Day 0
Rate of type 1 pelvic kinematic disorder between groups
Measured by sacral slope difference from standing to seated position < 12°.
Measured: Day 0
Secondary outcomes (9)
Lumbar lordosis between standing and seating between groups
degree
Measured: Day 0
Femoroacetabular flexion between standing and seating between groups
degree
Measured: Day 0
Lewinnek plane (Anterior pelvic plane) between standing and seating between groups
degree
Measured: Day 0
Pelvic version between standing and seating between groups
degree
Measured: Day 0
Classification of patients' pelvic kinematic disorder (Type 1 or 2)
Type 1 = Difference in sacral slope between standing and seated position < 12° Type 2 = pelvic version < 20° standing
Measured: Day 0
Classification of patients according to pelvic incidence
Presence/absence
Measured: Day 0
Classification of patients according to sacral slope
Presence/absence
Measured: Day 0
Classification of patients according to sagittal imbalance
Presence/absence of: Sagittal Vertical Axis > 50 mm; Spino-Sacral Angle < 127°
Measured: Day 0
Evolution of acetabular positioning (anteversion and inclination in degree) from standing to sitting
Degree
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 posted27 Jul 2018
- Study start6 Jul 2018
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal Kouyoumdjian, MD, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603470
- Sponsor's protocol ID
- AOIGCSMERRI/2017/PK-01
- Acronym
- HIPEOS
- Status last verified
- Aug 2020
- First submitted
- 2 Jul 2018
- Last updated
- 4 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Hip Arthroplasty Instability and Lumbo-pelvic Kinematics: EOS Imaging Assessment of Variation in Spinal and Pelvic Parameters From Standing to Sitting
- ClinicalTrials.gov ID
- NCT03603470
- Acronym / sponsor ID
- HIPEOS / AOIGCSMERRI/2017/PK-01
- Conditions
- Hip Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 6 Jul 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 27 Jul 2018 (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.
The authors hypothesize that a pelvic kinematic disorder, demonstrated by a significant decrease in sacral slope, is associated with the risk of instability of total hip prosthesis, the sacral slope being measured by an EOS imaging system during the transition to sitting in unstable patients versus patients with no history of instability.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with previous prothesis instability | Other | Other: EOS imagery |
| Patients without prothesis instability | Other | Other: EOS imagery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- The patient must be at least 18 years old and less than 85 years old
- Patient has a conventional first intention total hip arthroplasty (not dual mobility) by posterior approach
- "Case" patients have at least one previous episode of prosthetic dislocation repaired with surgery
Key exclusion criteria (12 listed)
- The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient is pregnant, parturient or breastfeeding
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 |
|---|---|---|
| EOS imageryWhole body EOS imaging in seated and standing position | Other | Patients with previous prothesis instability, Patients without prothesis instability |
Primary outcome
Sacral slope between standing to sitting difference between groups
Time frame: Day 0
Sacral slope between standing to sitting difference between groups
Rate of type 1 pelvic kinematic disorder between groups
Time frame: Day 0
Measured by sacral slope difference from standing to seated position < 12°.
9 secondary outcomes
Lumbar lordosis between standing and seating between groups
Time frame: Day 0
Femoroacetabular flexion between standing and seating between groups
Time frame: Day 0
Lewinnek plane (Anterior pelvic plane) between standing and seating between groups
Time frame: Day 0
Pelvic version between standing and seating between groups
Time frame: Day 0
Classification of patients' pelvic kinematic disorder (Type 1 or 2)
Time frame: Day 0
Classification of patients according to pelvic incidence
Time frame: Day 0
Classification of patients according to sacral slope
Time frame: Day 0
Classification of patients according to sagittal imbalance
Time frame: Day 0
Evolution of acetabular positioning (anteversion and inclination in degree) from standing to sitting
Time frame: Day 0
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 4 Aug 2020.
Related trials for Hip Fractures
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures
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.
Pascal Kouyoumdjian, MD principal investigator
CHU Nimes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EOS imagery in people with Hip Fractures, run by Centre Hospitalier Universitaire de Nīmes at 2 sites 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 6 inclusion and 12 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 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Sacral slope between standing to sitting difference between groups (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2020.