RecruitingNot Applicable

A Study to Verify if the Surgery for the Proximal Femur Fracture Can be Improved With the Help of a Navigation System

Switzerland96 participantsStarted 2020-09-28

Plain-language summary

The ADAPT system is a software that calculate a virtual 3D reconstruction of the femoral head without additional radiation. It automatically detects the used implant and its position relative to the femoral head, helping the surgeon to achieve an optimal proximal screw positioning in the femoral head. The investigators want to verify if with the addition of the ADAPT system the investigators can improve screw placement and reduce surgery time and radiation exposure.

Who can participate

Age range

50 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

TAD (tip to apex) index at the post-operative X-Ray control prior discharge

Timeframe: immediately after the surgery

Trial details

NCT IDNCT04494672

SponsorChristian Candrian

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-01

Contact for this trial

Christian Candrian, MD

0041918117029 RicercaOrtopedia.ORL@eoc.ch

View on ClinicalTrials.gov More Femoral Fracture trials