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Total Hip Arthroplasty: Fluoroscopy vs Freehand

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05653687
Enrollment
84
Registered
2022-12-16
Start date
2023-05-22
Completion date
2028-03-01
Last updated
2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraoperative Fluoroscopy

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.

Interventions

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.

Sponsors

Ente Ospedaliero Cantonale, Bellinzona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Acetabular component anteversion2 months post-operativeAcetabular 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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026