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

NCT03789630 | Completed

• 1 other identifier: CT002
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Arthroplasty

Keywords

Knee Replacement; Wearable; Pain Score Quantification

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain Correlation in Opioid Medication Subgroup

  30 days

• Pain Correlation (3 pain categories)

  30 days

Study Arms (1)

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

Interventions

Continuous physiology monitoring in ambulatory setting pre and post surgery DEVICE

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.

Monitoring arm

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Biofourmis Singapore Pte Ltd.: lead
• Mundipharma Research Limited: collaborator

Study Sites (1)

Singapore General Hospital (SGH)

Singapore, 169865, Singapore

Location

MeSH Terms

Interventions

Postoperative Period

Intervention Hierarchy (Ancestors)

Perioperative Period; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: December 28, 2018
• Study Start: February 2, 2019
• Primary Completion: August 17, 2020
• Study Completion: August 17, 2020
• Last Updated: October 27, 2022

Record last verified: 2022-10

Locations

SG (1)