Total Hip Arthroplasty: Fluoroscopy vs Freehand
A Randomized, Monocentric Investigator-initiated Clinical Investigation Comparing Fluoroscopy Versus Freehand in Total Hip Arthroplasty
1 other identifier
interventional
84
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2022
CompletedFirst Posted
Study publicly available on registry
December 16, 2022
CompletedStudy Start
First participant enrolled
May 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedAugust 8, 2025
August 1, 2025
2.8 years
December 6, 2022
August 5, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Fluoroscopy
EXPERIMENTALFreehand
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ente Ospedaliero Cantonale
Lugano, Canton Ticino, 6900, Switzerland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 6, 2022
First Posted
December 16, 2022
Study Start
May 22, 2023
Primary Completion
March 1, 2026
Study Completion
March 1, 2026
Last Updated
August 8, 2025
Record last verified: 2025-08