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

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 Overview

• Status: Completed
• Conditions: Hip Fractures
• Intervention / Treatment: Other: EOS imagery

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • CHU Lapeyronie de Montpellier
  • Nîmes, France, 30029
    • CHU Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients with previous prothesis instability	Other: EOS imagery; Whole body EOS imaging in seated and standing position
Other: Patients without prothesis instability	Other: EOS imagery; Whole body EOS imaging in seated and standing position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sacral slope between standing to sitting difference between groups	Sacral slope between standing to sitting difference between groups	Day 0
Rate of type 1 pelvic kinematic disorder between groups	Measured by sacral slope difference from standing to seated position < 12°.	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lumbar lordosis between standing and seating between groups	degree	Day 0
Femoroacetabular flexion between standing and seating between groups	degree	Day 0
Lewinnek plane (Anterior pelvic plane) between standing and seating between groups	degree	Day 0
Pelvic version between standing and seating between groups	degree	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	Day 0
Classification of patients according to pelvic incidence	Presence/absence	Day 0
Classification of patients according to sacral slope	Presence/absence	Day 0
Classification of patients according to sagittal imbalance	Presence/absence of: Sagittal Vertical Axis > 50 mm; Spino-Sacral Angle < 127°	Day 0
Evolution of acetabular positioning (anteversion and inclination in degree) from standing to sitting	Degree	Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Pascal Kouyoumdjian, MD, CHU Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2018
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: July 2, 2018
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): August 4, 2020
• Last Update Submitted That Met QC Criteria: August 3, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures
• Other Study ID Numbers: AOIGCSMERRI/2017/PK-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No