Early Post-operative Monitoring by Sensor of Patients Undergoing Forefoot Surgery

Foot Injury Clinical Trial

Official title:

Early Post-operative Monitoring by Sensor of Patients Undergoing Forefoot Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06242002
• Other study ID #: 2023-A02074-41
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2024
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Clinique de lEurope a Amiens
• Contact: Julien Beldame, MD
• Phone: +336 74 44 08 56
• Email: julien.beldame[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 patient's 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 (e.g. icing instructions via the temperature sensor, instructions to reduce locomotor activity, etc.) .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Foot Injuries
• Foot Injury

Intervention

Procedure:
• Set up of sensor
Surgery is performed as usual for patients needing this medical procedure. At the end, the sensor is set up under the surgical dressing.

Locations

Country	Name	City	State
France	Clinique de l'Europe à Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Clinique de lEurope a Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Step count	Collecting step count data on the server	Every 4 hours during 7 days
Primary	local temperature	Collecting local temperature data on the server	Every 4 hours during 7 days
Primary	distance traveled (kilometers)	Collecting data on the distance traveled by the patient on the server, (in kilometers). Distance is measured by the global positioning system beacon of the sensor.	Every 4 hours during 7 days
Secondary	Patient's satisfaction : questionnaire	Patients satisfaction will be evaluated by a questionnaire with 5 items. 4 items are "yes-no" questions, and the last one is a Likert scale of 5 levels (from "not at all satisfied" to "very satisfied").	day 8