A Randomized, Monocentric Investigator-initiated Clinical Investigation Comparing Fluoroscopy Versus Freehand in Total Hip Arthroplasty
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Intraoperative Fluoroscopy
- Sponsor
- Ente Ospedaliero Cantonale, Bellinzona
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Acetabular component anteversion
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
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.
Investigators
Christian Candrian
Principal Investigator
Ente Ospedaliero Cantonale, Bellinzona
Eligibility Criteria
Inclusion Criteria
- •Patients undergoing unilateral primary THA through DAA
- •Patients aged 18-90 years old.
- •Patients with a BMI \>18 and \<
- •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.
Outcomes
Primary Outcomes
Acetabular component anteversion
Time Frame: 2 months post-operative
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.