Improving surgery for proximal femur fractures using a navigation system
Improving Intramedullary Nailing of Proximal Femoral Fractures Through a Navigation Assisted Technique: a Double Blinded Randomized Control Trial
This study is testing a new navigation system during surgery for hip fractures to see if it can make the surgery safer and more accurate for people aged 50 to 85.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | Ente Ospedaliero Cantonale, Bellinzona Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Lugano) |
| Trial ID | NCT04494672 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the ADAPT system, a software that creates a virtual 3D reconstruction of the femoral head, in improving the surgical outcomes of intramedullary nailing for proximal femur fractures. The study is a randomized controlled trial with two arms: one group will undergo surgery with the ADAPT system, while the other will have the standard procedure without it. The trial aims to assess whether the ADAPT system can enhance screw placement accuracy, reduce surgery time, and minimize radiation exposure. A total of 96 patients aged 50-85 with specific fracture classifications will be enrolled at the Ospedale Regionale di Lugano.
Who should consider this trial
Good fit: Ideal candidates are patients aged 50-85 undergoing unilateral primary intramedullary nailing for specific types of proximal femur fractures.
Not a fit: Patients with significant concomitant diseases or those unable to comply with study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more efficient surgeries for patients with proximal femur fractures.
How similar studies have performed: Previous studies exploring similar navigation systems have shown promise, although they were underpowered, making this trial a critical step in validating the approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing unilateral primary intramedullary nailing at the Ospedale Regionale di Lugano. * Patients aged 50-85 years old. * Patients with a BMI \>18 and \<35. * Patients able to provide informed consent and follow all the study procedures as indicated by the protocol. * Radiological evidence of proximal fracture of the femur, AO classified as 31 A1.3, 31 A2.1, 31 A2.2, 31 A2.3, 31 A3.1, 31 A3.2, 31 A3.3. Exclusion Criteria: * Other clinically significant concomitant disease states (e.g. renal failure, major hepatic dysfunction, life-threatening cardiovascular disease, etc..). * Known or suspected non-compliance, drug or alcohol abuse. * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant. * 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
- Christian Candrian — Lugano, Switzerland (Recruiting)
Study contacts
- Principal investigator: Christian Candrian, MD — Ente Ospedaliero Cantonale, Bellinzona
- Study coordinator: Christian Candrian, MD
- Email: RicercaOrtopedia.ORL@eoc.ch
- Phone: 0041918117029
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.