CompletedNot Applicable

Assessment of the Surgical Handling and Performance of the X-ray-based Tracking and Navigation System "Xin1 Humerus System" Evaluated From 10 Proximal Humerus Plate Fixations

Belgium11 participantsStarted 2017-04-04

Plain-language summary

Xin1 Humerus system is an X-ray-based tracking and navigation system designed to calculate the plate position and all required proximal screw lengths for proximal humerus plate fixation. The aim is to validate the system performance in a clinical context and test the surgical handling of the Xin1 marker in a hospital environment. 10 adults having sustained a proximal humerus fracture and are indicated for plate fixation osteosynthesis will be provided intraoperatively with the Xin1 marker. The system performance is evaluated retrospectively by post-processing the intraoperative X-ray images after surgery

Who can participate

Age range

18 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: * Age 18 years and older * Diagnosis of proximal humerus fracture * Indicated for plate fixation osteosynthesis * Informed consent obtained

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?

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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

Influence of plate fixation on the determined screw lengths derived from the Xin1 Humerus System

Timeframe: during surgery

Trial details

NCT IDNCT03427112

SponsorAO Research Institute Davos

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-03-06

View on ClinicalTrials.gov More Proximal Humeral Fracture trials