Continuous Monitoring of Physiology and Self-reported Pain Score Amongst Post-surgical Knee Patients (NCT03789630) | Clinical Trial Compass
CompletedNot Applicable
Continuous Monitoring of Physiology and Self-reported Pain Score Amongst Post-surgical Knee Patients
Singapore55 participantsStarted 2019-02-02
Plain-language 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.
Who can participate
Age range21 Years – 80 Years
SexALL
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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