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Total Hip Arthroplasty: Fluoroscopy vs Freehand

E

Ente Ospedaliero Cantonale, Bellinzona

Status

Enrolling

Conditions

Intraoperative Fluoroscopy

Treatments

Device: Intraoperative fluoroscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT05653687
ORL-ORT-036

Details and patient eligibility

About

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.

Enrollment

84 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

84 participants in 2 patient groups

Fluoroscopy
Experimental group
Treatment:
Device: Intraoperative fluoroscopy
Freehand
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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