Early Post-operative Monitoring by Sensor of Patients Undergoing Forefoot Surgery (NCT06242002) | Clinical Trial Compass
CompletedNot Applicable
Early Post-operative Monitoring by Sensor of Patients Undergoing Forefoot Surgery
France30 participantsStarted 2024-01-19
Plain-language summary
The goal of this clinical trial is to evaluate the monitoring using a sensor in patients who have undergone forefoot surgery, during the first 7 post-operative days.
The monitoring tool has a Global Positioning System (GPS) beacon, a 3-axis accelerometer and a temperature sensor, as well as an "emergency call" button.
The main objective it aims to answer are:
* to evaluate the feasibility of post-operative monitoring using this tool
* to evaluate the reliability of the tool
The investigators hope to determine if using this tool can be able to provide patients a "connected" personalized real-time monitoring for follow-up.
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:
* Patients undergoing forefoot surgery
* Patient having given informed consent
Exclusion Criteria:
* Patient deprived of his liberty or under guardianship
* Patient undergoing surgery other than the forefoot (hallux and lateral toes)
* Patient unable to undergo protocol monitoring for psychological, social, family, geographic or linguistic reasons
* Patient with an underlying or concomitant pathology incompatible with inclusion in the trial, whether psychiatric or somatic
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.