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

NCT03603470 | Completed

• 1 other identifier: AOIGCSMERRI/2017/PK-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Lumbar lordosis between standing and seating between groups

  Day 0

• Femoroacetabular flexion between standing and seating between groups

  Day 0

• Lewinnek plane (Anterior pelvic plane) between standing and seating between groups

  Day 0

• Pelvic version between standing and seating between groups

  Day 0

• Classification of patients' pelvic kinematic disorder (Type 1 or 2)

  Day 0

Study Arms (2)

Patients with previous prothesis instability

OTHER

Other: EOS imagery

Patients without prothesis instability

OTHER

Other: EOS imagery

Interventions

EOS imagery OTHER

Whole body EOS imaging in seated and standing position

Patients with previous prothesis instability; Patients without prothesis instability

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

CHU Lapeyronie de Montpellier

Montpellier, 34295, France

Location

CHU Nimes

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Pascal Kouyoumdjian, MD

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 27, 2018
• Study Start: July 6, 2018
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: August 4, 2020

Record last verified: 2020-08

Locations

FR (2)