Early Post-operative Monitoring by Sensor of Patients Undergoing Forefoot

Status Recruiting

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.

Clinical Trial 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.) . ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06242002
Study type	Interventional
Source	Clinique de lEurope a Amiens
Contact	Julien Beldame, MD
Phone	+336 74 44 08 56
Email	julien.beldame@gmail.com
Status	Recruiting
Phase	N/A
Start date	January 19, 2024
Completion date	December 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05444192` - Comparing Clinical Outcomes Using Two Insole Manufacture Techniques	N/A
Recruiting	`NCT05555459` - Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation	N/A
Completed	`NCT06086418` - Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery	Phase 4
Not yet recruiting	`NCT05762588` - JuggerKnot With Broadband PMCF Study
Terminated	`NCT02953067` - Study of Treatment of Lisfranc Injuries	N/A
Not yet recruiting	`NCT06352788` - From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices	N/A
Completed	`NCT02645097` - Ideal Anatomic Location for Saphenous Nerve Blocks: A Prospective Clinical Evaluation	N/A
Completed	`NCT05190159` - Monster Screw System Post-Market Clinical Follow-Up Study
Active, not recruiting	`NCT04967040` - Reconstruction of Ankle and Foot Defects	N/A
Terminated	`NCT02643524` - Weight Change With Controlled Ankle Movement (CAM) Walker Boot Use	N/A
Recruiting	`NCT06300671` - The Effect of Subtalar Joint Pronation Amount on Lower Extremity Alignment and Performance	N/A
Completed	`NCT05323773` - How is Calf Muscle Endurance Related to Ankle Injuries in TeamGym Athletes?
Not yet recruiting	`NCT06304324` - Dexmedetomidine vs Dexamethasone in Popliteal Nerve Block	Phase 4
Completed	`NCT05090059` - Myofascial Points Treatment With Focused Extracorporeal Shock Waves (ESW)	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms