Skip to main content
OpenTrials
Completed

NCT Number: NCT03603470

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Lapeyronie de Montpellier, Montpellier, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

EOS imagery

Other

Whole body EOS imaging in seated and standing position

Primary outcomes

  1. Sacral slope between standing to sitting difference between groups

    Time frame: Day 0

    Sacral slope between standing to sitting difference between groups

  2. 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

  1. Lumbar lordosis between standing and seating between groups

    Time frame: Day 0

    degree

  2. Femoroacetabular flexion between standing and seating between groups

    Time frame: Day 0

    degree

  3. Lewinnek plane (Anterior pelvic plane) between standing and seating between groups

    Time frame: Day 0

    degree

  4. Pelvic version between standing and seating between groups

    Time frame: Day 0

    degree

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

    Time frame: Day 0

    Type 1 = Difference in sacral slope between standing and seated position < 12° Type 2 = pelvic version < 20° standing

  6. Classification of patients according to pelvic incidence

    Time frame: Day 0

    Presence/absence

  7. Classification of patients according to sacral slope

    Time frame: Day 0

    Presence/absence

  8. Classification of patients according to sagittal imbalance

    Time frame: Day 0

    Presence/absence of: Sagittal Vertical Axis > 50 mm; Spino-Sacral Angle < 127°

  9. Evolution of acetabular positioning (anteversion and inclination in degree) from standing to sitting

    Time frame: Day 0

    Degree

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: HIPEOS

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 27, 2018
Registry last updated
Aug 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.