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Recruiting

NCT Number: NCT05653687

Total Hip Arthroplasty: Fluoroscopy vs Freehand

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.

Recruiting

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ente Ospedaliero Cantonale

Lugano, Canton Ticino, 6900, Switzerland

Location status: Recruiting

Location contact

Alessandro Bensa, Dr.

CONTACT

[email protected]

0918117029

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Intraoperative fluoroscopy

Device

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 outcomes

  1. Acetabular component anteversion

    Time frame: 2 months post-operative

    Acetabular component anteversion will be measured on post-operative control antero-posterior pelvis view X-ray performed as per clinical practice using the PACS software according to the method described by Lewinnek et al. This method is based on the following equation to measure radiographic anteversion β.

    β = arcsin(S/L)

    Where S is the length of the short axis and L is the length of long axis of the ellipse. The ellipse is formed by the outer ring of the acetabulum component on the anteroposterior pelvis view X-ray.

Sponsors and collaborators

Lead sponsor

Ente Ospedaliero Cantonale, Bellinzona

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2022
Registry last updated
Aug 8, 2025

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.