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

NCT ID: NCT06242002

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-19
• Study Completion Date: 2025-01-31

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.

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 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.) .

Conditions

Foot Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

For patients participating to the clinical trial, the sensor will be positioned at the end of the procedure, under the surgical dressing, at ankle level.

This dressing is a definitive dressing which is only removed during the post-operative consultation on day 8, during which the sensor will be removed.

During this 7 days, data from the sensor will be collected every 4 hours.

Group Type: EXPERIMENTAL

Set up of sensor

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinique de lEurope a Amiens

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique de l'Europe à Amiens

Amiens, , France

Countries

France

Other Identifiers

2023-A02074-41

Identifier Type: -

Identifier Source: org_study_id