Continuous Monitoring of Physiology and Self-reported Pain Score Amongst Post-surgical Knee Patients
NCT ID: NCT03789630
Last Updated: 2022-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
55 participants
OBSERVATIONAL
2019-02-02
2020-08-17
Brief Summary
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Detailed Description
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This study will recruit 55 patients aged 21 to 80 years who will be undergoing knee replacement, Anterior Cruciate Ligament(ACL), Knee Arthroscopy and Foot \& Ankle related surgery. All study participants will be followed for an estimated total of 30 days(+6/-2 days, if visit schedule is fall on weekend), beginning four days before surgery, the entire period as an in-patient (four to five days), and 20-days post-discharge.
The changes in multivariate physiological biomarkers will be used to generate a Pain Index, and the Pain Index will be assessed against patient reported Numerical Rating Scale (NRS) pain.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Monitoring arm
Monitoring subjects undergoing total knee replacement surgery using the wearable biosensor to continuously monitor physiology biomarkers.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
80 Years
ALL
No
Sponsors
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Mundipharma Research Limited
INDUSTRY
Biofourmis Singapore Pte Ltd.
INDUSTRY
Responsible Party
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Locations
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Singapore General Hospital (SGH)
Singapore, , Singapore
Countries
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Other Identifiers
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CT002
Identifier Type: -
Identifier Source: org_study_id
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