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

Centre Hospitalier Universitaire de Nīmes2 sites in 1 country80 target enrollmentJuly 6, 2018

ConditionsHip Fractures

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hip Fractures
Sponsor: Centre Hospitalier Universitaire de Nīmes
Enrollment: 80
Locations: 2
Primary Endpoint: Sacral slope between standing to sitting difference between groups
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 6, 2018

End Date

February 1, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire de Nīmes

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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°.

Secondary Outcomes

Lumbar lordosis between standing and seating between groups(Day 0)
Lewinnek plane (Anterior pelvic plane) between standing and seating between groups(Day 0)
Classification of patients' pelvic kinematic disorder (Type 1 or 2)(Day 0)
Femoroacetabular flexion between standing and seating between groups(Day 0)
Pelvic version between standing and seating between groups(Day 0)
Classification of patients according to pelvic incidence(Day 0)
Classification of patients according to sagittal imbalance(Day 0)
Classification of patients according to sacral slope(Day 0)
Evolution of acetabular positioning (anteversion and inclination in degree) from standing to sitting(Day 0)