Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06242002
Status:
RECRUITING
Last Update Posted:
2024-02-05
First Post:
2024-01-25
Brief Title:
Early Post-operative Monitoring by Sensor of Patients Undergoing Forefoot Surgery
Sponsor:
Clinique de lEurope a Amiens
Organization:
Clinique de lEurope a Amiens
Study Overview
Official Title:
Early Post-operative Monitoring by Sensor of Patients Undergoing Forefoot Surgery
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Currently patients undergoing forefoot surgery often do so in an outpatient setting and thus spend less and less time in the healthcare establishment in contact with the nursing staff being increasingly left to themselves at home The development of telemedicine with real-time information transfer can enable the monitoring of acute or chronic pathologies thus allowing a link between the patient and the healthcare network for more personalized monitoring
Post-operative pain following forefoot surgery is now well controlled allowing greater patient autonomy despite post-operative footwear However the patients autonomy locomotor and mobilization capacity are not known
The investigators therefore propose monitoring the first 7 post-operative days using a sensor in patients who have undergone forefoot surgery This 7-day period corresponds to the critical period of foot surgery with resumption of post-operative support lifting of loco-regional anesthesia and return home This monitoring will be done from discharge from the service until the first post-operative visit The monitoring will be prospective with non-invasive measurements via an electronic sensor already used for sporting activities notably long-distance running This will be a clinical practice study with no modification to monitoring or current practices 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 recorded parameters will be the number of steps local temperature and GPS position of the patient The data will be transmitted via an independent cellular network and to a secure space username and password accessible online
The main objective will be to evaluate the feasibility of post-operative monitoring using this tool The secondary objectives will be to evaluate the reliability of the tool to evaluate the transmission of the GPS signal and to collect the data
Following this study the investigators hope to be able to provide patients with real-time monitoring via alerts received on the smartphone eg icing instructions via the temperature sensor instructions to reduce locomotor activity etc
Post-operative pain following forefoot surgery is now well controlled allowing greater patient autonomy despite post-operative footwear However the patients autonomy locomotor and mobilization capacity are not known
The investigators therefore propose monitoring the first 7 post-operative days using a sensor in patients who have undergone forefoot surgery This 7-day period corresponds to the critical period of foot surgery with resumption of post-operative support lifting of loco-regional anesthesia and return home This monitoring will be done from discharge from the service until the first post-operative visit The monitoring will be prospective with non-invasive measurements via an electronic sensor already used for sporting activities notably long-distance running This will be a clinical practice study with no modification to monitoring or current practices 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 recorded parameters will be the number of steps local temperature and GPS position of the patient The data will be transmitted via an independent cellular network and to a secure space username and password accessible online
The main objective will be to evaluate the feasibility of post-operative monitoring using this tool The secondary objectives will be to evaluate the reliability of the tool to evaluate the transmission of the GPS signal and to collect the data
Following this study the investigators hope to be able to provide patients with real-time monitoring via alerts received on the smartphone eg icing instructions via the temperature sensor instructions to reduce locomotor activity etc
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None