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 range

21 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain Correlation (using binary pain classification)

Timeframe: 30 days

Trial details

NCT IDNCT03789630

SponsorBiofourmis Singapore Pte Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-08-17

View on ClinicalTrials.gov More Knee Arthroplasty trials