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

NCT06242002 | Completed

• 1 other identifier: 2023-A02074-41
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Foot Injury

Keywords

foot; surgery; sensor; post-surgical follow-up

Outcome Measures

Primary Outcomes (3)

• Step count

  Collecting step count data on the server

  Every 4 hours during 7 days

• local temperature

  Collecting local temperature data on the server

  Every 4 hours during 7 days

• 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 Outcomes (1)

• Patient's satisfaction : questionnaire

  day 8

Study Arms (1)

Experimental group

EXPERIMENTAL

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.

Procedure: Set up of sensor

Interventions

Set up of sensor PROCEDURE

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

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing forefoot surgery
• Patient having given informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique de lEurope a Amiens: lead

Study Sites (1)

Clinique de l'Europe à Amiens

Amiens, 80090, France

Location

MeSH Terms

Conditions

Foot Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 5, 2024
• Study Start: January 19, 2024
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)