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

NCT03789630 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2022-10-27

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Mundipharma Research Limited

    collaborator INDUSTRY

  • Biofourmis Singapore Pte Ltd.

    lead INDUSTRY

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-02
Primary Completion
2020-08-17
Completion
2020-08-17

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03789630 on ClinicalTrials.gov