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Recruiting NCT05653687

Total Hip Arthroplasty: Fluoroscopy vs Freehand

No phase Interventional Intraoperative Fluoroscopy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intraoperative fluoroscopy.
Who it may be relevant to
Registry conditions: Intraoperative Fluoroscopy. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Randomized, Monocentric Investigator-initiated Clinical Investigation Comparing Fluoroscopy Versus Freehand in Total Hip Arthroplasty

Overview

The aim of the study is to compare total hip arthroplasty intervention executed with or without the use of intraoperative fluoroscopy in terms of positioning of the hip prosthesis. The comparison will be made on post-operative follow-up X-ray performed as per clinical practice, in order to verify if intraoperative fluoroscopy provides better prosthesis components positioning or not.

Interventions

  • Device Intraoperative fluoroscopy
    Fluoroscopy is a medical procedure that makes a real-time video of the movements inside a part of the body by passing x-rays through the body over a period of time.

Primary outcome measures

  • Acetabular component anteversion [Time frame: 2 months post-operative]

Eligibility criteria

Inclusion criteria

  • Patients undergoing unilateral primary THA through DAA
  • Patients aged 18-90 years old.
  • Patients with a BMI >18 and <35.
  • Patients able to provide informed consent.
  • Informed consent as documented by signature.

Exclusion criteria

  • Revision THA.
  • Women who are pregnant or breast feeding.
  • Presence of other clinically significant concomitant disease states (ASA IV).
  • Previous enrolment into the current study.
  • Enrolment of the investigator, his/her family members, employees and other dependent persons.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Switzerland · 1 center
  • Ente Ospedaliero Cantonale — Lugano

Identifiers

NCT: NCT05653687 · ORL-ORT-036

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗