Status:
COMPLETED
Continuous Monitoring of Physiology and Self-reported Pain Score Amongst Post-surgical Knee Patients
Lead Sponsor:
Biofourmis Singapore Pte Ltd.
Collaborating Sponsors:
Mundipharma Research Limited
Conditions:
Knee Arthroplasty
Eligibility:
All Genders
21-80 years
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 s...
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 mo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 2 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 17 2020
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT03789630
Start Date
February 2 2019
End Date
August 17 2020
Last Update
October 27 2022
Active Locations (1)
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1
Singapore General Hospital (SGH)
Singapore, Singapore, 169865