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

Hip Fractures Clinical Trial

— HIPEOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03603470
• Other study ID #: AOIGCSMERRI/2017/PK-01
• Status: Completed
• Phase: N/A
• Start date: July 6, 2018
• Est. completion date: February 1, 2019

Study information

• Verified date: August 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 history of instability.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hip Fractures

Intervention

Other:
• EOS imagery
Whole body EOS imaging in seated and standing position

Locations

Country	Name	City	State
France	CHU Lapeyronie de Montpellier	Montpellier
France	CHU Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sacral slope between standing to sitting difference between groups	Sacral slope between standing to sitting difference between groups	Day 0
Primary	Rate of type 1 pelvic kinematic disorder between groups	Measured by sacral slope difference from standing to seated position < 12°.	Day 0
Secondary	Lumbar lordosis between standing and seating between groups	degree	Day 0
Secondary	Femoroacetabular flexion between standing and seating between groups	degree	Day 0
Secondary	Lewinnek plane (Anterior pelvic plane) between standing and seating between groups	degree	Day 0
Secondary	Pelvic version between standing and seating between groups	degree	Day 0
Secondary	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
Secondary	Classification of patients according to pelvic incidence	Presence/absence	Day 0
Secondary	Classification of patients according to sacral slope	Presence/absence	Day 0
Secondary	Classification of patients according to sagittal imbalance	Presence/absence of: Sagittal Vertical Axis > 50 mm; Spino-Sacral Angle < 127°	Day 0
Secondary	Evolution of acetabular positioning (anteversion and inclination in degree) from standing to sitting	Degree	Day 0