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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06242002
Enrollment
30
Registered
2024-02-05
Start date
2024-01-19
Completion date
2025-01-31
Last updated
2025-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Foot Injury

Keywords

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

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.) .

Interventions

PROCEDURESet 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.

Sponsors

Clinique de lEurope a Amiens
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Step countEvery 4 hours during 7 daysCollecting step count data on the server
local temperatureEvery 4 hours during 7 daysCollecting local temperature data on the server
distance traveled (kilometers)Every 4 hours during 7 daysCollecting 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.

Secondary

MeasureTime frameDescription
Patient's satisfaction : questionnaireday 8Patients 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).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026