Total Hip Arthroplasty: Fluoroscopy vs Freehand
ConditionIntraoperative Fluoroscopy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorEnte Ospedaliero Cantonale, Bellinzona
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Intraoperative fluoroscopy
DeviceFluoroscopy 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.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: FluoroscopyExperimental treatment 1 intervention
Group B: FreehandNo intervention 0 interventions
Trial outcomes
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.
Time frame
2 months post-operativeSponsors and contacts
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Source ClinicalTrials.gov