Clinical trial NCT03603470: Total Hip Arthroplasty Instability and Lumbo-pelvic Kinematics: EOS Imaging Assessment of Variation in Spinal and Pelvic Parameters From Standing to Sitting
Official title: Total Hip Arthroplasty Instability and Lumbo-pelvic Kinematics: EOS Imaging Assessment of Variation in Spinal and Pelvic Parameters From Standing to Sitting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Sacral slope between standing to sitting difference between groups
timeFrame: Day 0
measure: Rate of type 1 pelvic kinematic disorder between groups
timeFrame: Day 0
Secondary outcomes:
measure: Lumbar lordosis between standing and seating between groups
timeFrame: Day 0
measure: Femoroacetabular flexion between standing and seating between groups
timeFrame: Day 0
measure: Lewinnek plane (Anterior pelvic plane) between standing and seating between groups
timeFrame: Day 0
measure: Pelvic version between standing and seating between groups
timeFrame: Day 0
measure: Classification of patients' pelvic kinematic disorder (Type 1 or 2)
timeFrame: Day 0
measure: Classification of patients according to pelvic incidence
timeFrame: Day 0
measure: Classification of patients according to sacral slope
timeFrame: Day 0
measure: Classification of patients according to sagittal imbalance
timeFrame: Day 0
measure: Evolution of acetabular positioning (anteversion and inclination in degree) from standing to sitting
timeFrame: Day 0
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU Lapeyronie de Montpellier
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
affiliation: CHU Nimes
name: Pascal Kouyoumdjian, MD
role: PRINCIPAL_INVESTIGATOR
References: