Comparing hip surgery with and without fluoroscopy
A Randomized, Monocentric Investigator-initiated Clinical Investigation Comparing Fluoroscopy Versus Freehand in Total Hip Arthroplasty
NA · Ente Ospedaliero Cantonale, Bellinzona · NCT05653687
This study is testing whether using a special imaging technique during hip surgery leads to better placement of the hip implant and improved recovery for patients compared to the traditional method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Ente Ospedaliero Cantonale, Bellinzona (other) |
| Locations | 1 site (Lugano, Canton Ticino) |
| Trial ID | NCT05653687 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the outcomes of total hip arthroplasty performed with intraoperative fluoroscopy versus the traditional freehand method. The focus is on evaluating the positioning of the hip prosthesis by analyzing post-operative X-rays. By assessing the accuracy of prosthesis placement, the study seeks to determine if fluoroscopy enhances surgical precision and improves patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients aged 18-90 undergoing unilateral primary total hip arthroplasty.
Not a fit: Patients undergoing revision hip arthroplasty or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved accuracy in hip prosthesis placement, potentially reducing complications and enhancing recovery for patients.
How similar studies have performed: Previous studies have shown that intraoperative imaging techniques can improve surgical outcomes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Lugano, Canton Ticino
- Ente Ospedaliero Cantonale — Lugano, Canton Ticino, Switzerland (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Intraoperative Fluoroscopy