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Total Hip Arthroplasty Instability and Lumbo-pelvic Kinematics: EOS Imaging Assessment of Variation in Spinal and Pelvic Parameters From Standing to Sitting

Total Hip Arthroplasty Instability and Lumbo-pelvic Kinematics: EOS Imaging Assessment of Variation in Spinal and Pelvic Parameters From Standing to Sitting

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03603470
Acronym
HIPEOS
Enrollment
80
Registered
2018-07-27
Start date
2018-07-06
Completion date
2019-02-01
Last updated
2020-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Fractures

Brief 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 history of instability.

Interventions

OTHEREOS imagery

Whole body EOS imaging in seated and standing position

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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 * 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)

Design outcomes

Primary

MeasureTime frameDescription
Sacral slope between standing to sitting difference between groupsDay 0Sacral slope between standing to sitting difference between groups
Rate of type 1 pelvic kinematic disorder between groupsDay 0Measured by sacral slope difference from standing to seated position \< 12°.

Secondary

MeasureTime frameDescription
Lewinnek plane (Anterior pelvic plane) between standing and seating between groupsDay 0degree
Pelvic version between standing and seating between groupsDay 0degree
Classification of patients' pelvic kinematic disorder (Type 1 or 2)Day 0Type 1 = Difference in sacral slope between standing and seated position \< 12° Type 2 = pelvic version \< 20° standing
Lumbar lordosis between standing and seating between groupsDay 0degree
Classification of patients according to sacral slopeDay 0Presence/absence
Classification of patients according to sagittal imbalanceDay 0Presence/absence of: Sagittal Vertical Axis \> 50 mm; Spino-Sacral Angle \< 127°
Evolution of acetabular positioning (anteversion and inclination in degree) from standing to sittingDay 0Degree
Classification of patients according to pelvic incidenceDay 0Presence/absence
Femoroacetabular flexion between standing and seating between groupsDay 0degree

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026