NCT03789630

Continuous Monitoring of Physiology and Self-reported Pain Score Amongst Post-surgical Knee Patients

Observation of In-home Continuous Monitoring of Human Physiology and Self-reported Pain Score Among Knee Replacement, Anterior Cruciate Ligament (ACL), Knee Arthroscopy & Foot & Ankle Related Surgery Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 55 (actual)
• Sponsor: Biofourmis Singapore Pte Ltd. · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of this observational study is to assess whether patient reported pain levels correlate with a Pain Index derived from deviations in multivariate physiology biomarkers captured in real-world setting. This study will be conducted using a clinical-grade wearable sensor to continuously monitor patient's physiology (pain related biomarkers) and allow subject participant to actively report their pain score, symptoms and quality of life using a mobile-based application.

Detailed description

The designated clinical-grade wearable sensor used in this study is the Biovotion Everion MD (See Annex for product description), a Bluetooth-compatible device that will automatically sync with the mobile application used in this study. This study will recruit 55 patients aged 21 to 80 years who will be undergoing knee replacement, Anterior Cruciate Ligament(ACL), Knee Arthroscopy and Foot \& Ankle related surgery. All study participants will be followed for an estimated total of 30 days(+6/-2 days, if visit schedule is fall on weekend), beginning four days before surgery, the entire period as an in-patient (four to five days), and 20-days post-discharge. The changes in multivariate physiological biomarkers will be used to generate a Pain Index, and the Pain Index will be assessed against patient reported Numerical Rating Scale (NRS) pain.

Conditions

• Knee Arthroplasty

Interventions

Type	Name	Description
DEVICE	Continuous physiology monitoring in ambulatory setting pre and post surgery	This study will recruit 55 patients aged 21 to 80 years who will be undergoing total knee replacement surgery. All study participants undergoing total knee replacement surgery will be monitored using the wearable biosensor to continuously monitor physiology biomarkers. Participants will be followed for an estimated total of 39 days, beginning four days before surgery, the entire period during in-patient recovery (four to five days), and 30-days post-discharge at-home.

Timeline

• Start date: 2019-02-02
• Primary completion: 2020-08-17
• Completion: 2020-08-17
• First posted: 2018-12-28
• Last updated: 2022-10-27

Locations

1 site across 1 country: Singapore