RecruitingNot ApplicableNCT05653687

Total Hip Arthroplasty: Fluoroscopy vs Freehand

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


Sponsor

Ente Ospedaliero Cantonale, Bellinzona

Enrollment

84 participants

Start Date

May 22, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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.

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Interventions

DEVICEIntraoperative 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.


Locations(1)

Ente Ospedaliero Cantonale

Lugano, Canton Ticino, Switzerland

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NCT05653687