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

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

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.

Study Overview

• Status: Completed
• Conditions: Knee Arthroplasty
• Intervention / Treatment: Device: Continuous physiology monitoring in ambulatory setting pre and post surgery

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.

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 169865
    • Singapore General Hospital (SGH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

55 study participants, aged between 21 to 80 years, regardless of gender, who is undergoing total knee replacement surgery will be enrolled for the study upon receiving informed consent.

Description

Inclusion Criteria:

• Men and women aged 21 to 80 years
• Patients undergoing knee replacement surgery ( Total Knee Replacement (TKR), Unicompartmental Knee arthroplasty (UKA), Bilateral knee replacemenent, Patello-Femoral-Joint (PFJ) Knee replacement), Anterior Cruciate Ligament(ACL), Knee Arthroscopy and Foot & Ankle related surgery such as bunions, hammer toes, metatarsal, ankle fusion, triple fusion, ankle replacement, achilles tendon & tibialis posterior disorder
• Ability to provide informed consent
• Able to commit to using the app and inputting data as needed during the study duration
• Has access to an iPhone (minimum requirement iPhone 5S)

Exclusion Criteria:

• Previous myocardial infarction (MI)
• Known coronary artery disease - prior coronary revascularization
• Previous stroke. Stroke is defined as new focal neurological deficit perspective more than 24 hours.
• More than ongoing use of 2 or more anti-hypertensive agents.
• Expected life expectancy less than 1 year.
• Asthma or chronic lung disease requiring long-term medications or oxygen
• Mental illness that in the clinical judgment of the investigator will affect participation in the study e.g. dementia
• Inability to comply with the study protocol
• Any other acute or chronic medical or physical condition deemed by the investigator to affect study outcomes

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Monitoring arm; Monitoring subjects undergoing total knee replacement surgery using the wearable biosensor to continuously monitor physiology biomarkers.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Correlation (using binary pain classification)	Agreement between patient-reported NRS pain (classified into None-Mild and Moderate-Severe) and Pain Index, measured using Kappa statistic.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Correlation in Opioid Medication Subgroup	Agreement between patient-reported NRS pain and Pain Index in patients using opioid medication for post-surgical pain relief, measured using Kappa statistic.	30 days
Pain Correlation (3 pain categories)	Agreement between patient-reported NRS pain (classified into None-Mild, Moderate and Severe) and Pain Index, measured using Kappa statistic.	30 days

Collaborators and Investigators

• Sponsor: Biofourmis Singapore Pte Ltd.
• Collaborators: Mundipharma Research Limited

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 2, 2019
• Primary Completion (ACTUAL): August 17, 2020
• Study Completion (ACTUAL): August 17, 2020

Study Registration Dates

• First Submitted: December 27, 2018
• First Submitted That Met QC Criteria: December 27, 2018
• First Posted (ACTUAL): December 28, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Knee Replacement; Wearable; Pain Score Quantification
• Other Study ID Numbers: CT002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No