Knee ArthroplastyObservePAINNCT03789630
Continuous Monitoring of Physiology and Self-reported Pain Score Amongst Post-surgical Knee Patients
An observational study of Knee Arthroplasty, run by Biofourmis Singapore Pte Ltd. at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Knee Arthroplasty
- What is being tested?
- Continuous physiology monitoring in ambulatory setting pre and post surgery
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 1 siteSingapore
- Study dates
- 2 Feb 2019to 17 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 55 study participants, aged between 21 to 80 years, regardless of gender, who is undergoing total knee replacement surgery will be enrolled for the study upon receiving informed consent.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observation of In-home Continuous Monitoring of Human Physiology and Self-reported Pain Score Among Knee Replacement, Anterior Cruciate Ligament (ACL), Knee Arthroscopy & Foot & Ankle Related Surgery Patients
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.
Read the 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 mobile application used in this study.
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
- Knee Arthroplasty
- Being tested
- Continuous physiology monitoring in ambulatory setting pre and post surgery
- Keywords
- Knee Replacement, Wearable, Pain Score Quantification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous physiology monitoring in ambulatory setting pre and post surgeryDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Monitoring arm | Monitoring subjects undergoing total knee replacement surgery using the wearable biosensor to continuously monitor physiology biomarkers. Receives: Device: Continuous physiology monitoring in ambulatory setting pre and post surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Correlation (using binary pain classification)
Agreement between patient-reported NRS pain (classified into None-Mild and Moderate-Severe) and Pain Index, measured using Kappa statistic.
Measured: 30 days
Secondary outcomes (2)
Pain Correlation in Opioid Medication Subgroup
Agreement between patient-reported NRS pain and Pain Index in patients using opioid medication for post-surgical pain relief, measured using Kappa statistic.
Measured: 30 days
Pain Correlation (3 pain categories)
Agreement between patient-reported NRS pain (classified into None-Mild, Moderate and Severe) and Pain Index, measured using Kappa statistic.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start2 Feb 2019
- Primary completion17 Aug 2020
- Study completion17 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biofourmis Singapore Pte Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mundipharma Research Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789630
- Sponsor's protocol ID
- CT002
- Acronym
- ObservePAIN
- Status last verified
- Oct 2022
- First submitted
- 27 Dec 2018
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of In-home Continuous Monitoring of Human Physiology and Self-reported Pain Score Among Knee Replacement, Anterior Cruciate Ligament (ACL), Knee Arthroscopy & Foot & Ankle Related Surgery Patients
- ClinicalTrials.gov ID
- NCT03789630
- Acronym / sponsor ID
- ObservePAIN / CT002
- Conditions
- Knee Arthroplasty
- Keywords
- Knee Replacement, Wearable, Pain Score Quantification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Biofourmis Singapore Pte Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Mundipharma Research Limited
- Study start
- 2 Feb 2019 (actual)
- Primary completion
- 17 Aug 2020 (actual)
- Study completion
- 17 Aug 2020 (actual)
- First posted
- 28 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 mobile application used in this study.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monitoring arm | – | Device: Continuous physiology monitoring in ambulatory setting pre and post surgeryMonitoring subjects undergoing total knee replacement surgery using the wearable biosensor to continuously monitor physiology biomarkers. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 55 study participants, aged between 21 to 80 years, regardless of gender, who is undergoing total knee replacement surgery will be enrolled for the study upon receiving informed consent.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous physiology monitoring in ambulatory setting pre and post surgeryThis 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. | Device | Monitoring arm |
Primary outcome
Pain Correlation (using binary pain classification)
Time frame: 30 days
Agreement between patient-reported NRS pain (classified into None-Mild and Moderate-Severe) and Pain Index, measured using Kappa statistic.
2 secondary outcomes
Pain Correlation in Opioid Medication Subgroup
Time frame: 30 days
Pain Correlation (3 pain categories)
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Arthroplasty, run by Biofourmis Singapore Pte Ltd. at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Correlation (using binary pain classification) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.