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

NCT ID: NCT03603470

Last Updated: 2020-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-06
• Study Completion Date: 2019-02-01

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients with previous prothesis instability

Group Type: OTHER

EOS imagery

Intervention Type: OTHER

Whole body EOS imaging in seated and standing position

Patients without prothesis instability

Group Type: OTHER

EOS imagery

Intervention Type: OTHER

Whole body EOS imaging in seated and standing position

Interventions

EOS imagery

Whole body EOS imaging in seated and standing position

Intervention Type: OTHER

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
• Patient with obvious implant positioning error on an X-ray of the pelvis.
• Patient with dislocation of traumatic origin (significant kinetic trauma)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pascal Kouyoumdjian, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Nimes

Locations

CHU Lapeyronie de Montpellier

Montpellier, , France

CHU Nimes

Nîmes, , France

Countries

France

Other Identifiers

AOIGCSMERRI/2017/PK-01

Identifier Type: -

Identifier Source: org_study_id