Total Hip Arthroplasty: Fluoroscopy vs Freehand

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

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.

Study Overview

• Status: Recruiting
• Conditions: Intraoperative Fluoroscopy
• Intervention / Treatment: Device: Intraoperative fluoroscopy

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Ticino
    • Lugano, Ticino, Switzerland, 6900
      • Recruiting
      • Ente Ospedaliero Cantonale
      • Contact: Alessandro Bensa, Dr.; Phone Number: 0918117029; Email: alessandro.bensa@eoc.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluoroscopy	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.
No Intervention: Freehand

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acetabular component anteversion	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.	2 months post-operative

Collaborators and Investigators

• Sponsor: Ente Ospedaliero Cantonale, Bellinzona

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2023
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: December 14, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: ORL-ORT-036

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No