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

C

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Conditions

Hip Fractures

Treatments

Other: EOS imagery

Study type

Interventional

Funder types

Other

Identifiers

NCT03603470
AOIGCSMERRI/2017/PK-01

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

Patients with previous prothesis instability
Other group
Treatment:
Other: EOS imagery
Patients without prothesis instability
Other group
Treatment:
Other: EOS imagery

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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