Improving surgery for proximal femur fractures using a navigation system

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.