Arthropathy of KneeNCT03958370
Validation of Consumer Activity Monitors in Postoperative Total Arthroplasty Patients
An observational study of Arthropathy of Knee and Arthritis Knee, run by Benaroya Research Institute at 1 site in United States.
Trial summary
Mobilization and rehabilitation are essential components of a successful functional recovery following total hip and knee arthroplasties. Currently, we have no good measure of how mobile patients are after their surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Arthropathy of Knee, Arthritis Knee, Arthritis, Degenerative
- What is being tested?
- Fitbit
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2019to 31 Dec 2019
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any person who is over 18 years old, a procedural candidate (having a total arthroplasty surgery at Virginia Mason Medical Center), and can understand English sufficiently to consent for the study can be included
Who may be able to join
- primary unilateral total knee arthroplasty
- ASA class I-IV
- expected to ambulate with PT on postoperative day 1 or 2
- no history of chronic opioid or alcohol use
- no history of delirium
- ability to read and understand English
- patient agreement
Who cannot join
- patient refusal,
- bilateral arthroplasty patients,
- patients who are non- ambulatory preoperatively (e.g. wheelchair bound),
- patients who are not expected to ambulate with PT either due to intraoperative or postoperative complications,
- patients with contact precautions
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Virginia Mason Medical Center
Seattle, Washington, 98101
David B Auyong, MD, 206-223-6980, David.Auyong@virginiamason.org
David B Auyong, MD
About this study
Mobilization and rehabilitation are essential components of a successful functional recovery following total hip and knee arthroplasties. Currently, we have no good measure of how mobile patients are after their surgery. Recent technological advances in personal activity monitors, such as the Fitbit, might provide medical providers and patients the opportunity to more objectively monitor their postoperative mobility and recovery course. However, these consumer activity monitors have yet to be validated in terms of their accuracy and utility for monitoring mobility in the immediate postoperative setting in arthroplasty patients. Our goal is to validate one of the most popular consumer activity monitors, the Fitbit Zip, in the postoperative total joint arthroplasty patient population.
Read the detailed description
Early mobilization following total hip and knee arthroplasty surgeries is important in decreasing the risk of complications such as deep venous thrombosis, pulmonary embolus, pneumonia, and urinary retention. It is also generally accepted that early mobilization may help prevent late complications such as joint stiffness or arthrofibrosis. Aside from these complications, patient satisfaction and length of hospital stay both seem to be correlated with early mobilization with poor mobility negatively impacting both outcomes. Therefore, it is important for clinicians to ensure that patients are adequately mobilizing in the immediate postoperative period to promote a successful recovery after total hip or knee arthroplasty.
Consumer activity monitors are generally manufactured to be used in a relatively healthy, ambulatory population. Their accuracy has been validated in multiple studies in healthy subjects in a variety controlled settings. Based on these validity studies, it is clear that some of these consumer activity monitors have worse accuracy in certain situations, such as slower-paced walking or in people using assistive devices for ambulation, such as canes. The limitations of these devices in these settings could be problematic for monitoring post-arthroplasty patients since all these patients ambulate slowly, with an altered gait, and with a walker. No studies to date have looked at the accuracy of consumer activity monitors in the immediate postoperative arthroplasty population.
The consumer activity monitor market is rapidly evolving and changing, so much so that monitors used just last year might be obsolete this year. Therefore, rather than examining the accuracy of one device versus another, it is more applicable to determine what location is most accurate for placement of these monitors to help providers counsel patients on proper use postoperatively.
Our goal for this study is to validate and to determine the best location for placement of the Fitbit Zip in the postoperative total joint arthroplasty patient population.
- Conditions
- Arthropathy of Knee, Arthritis Knee, Arthritis, Degenerative
- Being tested
- Fitbit
- Keywords
- Fitbit, Activity Monitor, Step Count, Total Knee Replacement, Arthroplasty
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitbitOther
Fitbit use during physical therapy session
| Study group | Role | What they receive |
|---|---|---|
| Fitbit | Not described Receives: Other: Fitbit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Step Count Obtained from Fitbit
Comparing Fitbit step counts to observer counted steps during physical therapy sessions during inpatient stay
Measured: Postoperative day 0-2
Secondary outcomes (1)
Correlation of Step Count to Distance and Time Ambulated
See if Fitbit counts are more or less accurate depending on distance and time ambulated
Measured: Postoperative day 0-2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start8 Jan 2019
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthropathy of KneeStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benaroya Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Mason Hospital/Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958370
- Sponsor's protocol ID
- IRB17-053
- Status last verified
- May 2019
- First submitted
- 20 May 2019
- Last updated
- 22 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Consumer Activity Monitors in Postoperative Total Arthroplasty Patients
- ClinicalTrials.gov ID
- NCT03958370
- Acronym / sponsor ID
- IRB17-053
- Conditions
- Arthropathy of Knee, Arthritis Knee, Arthritis, Degenerative
- Keywords
- Fitbit, Activity Monitor, Step Count, Total Knee Replacement, Arthroplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Benaroya Research InstituteUniversity, hospital or other
- Collaborators
- Virginia Mason Hospital/Medical Center
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 22 May 2019 (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.
Mobilization and rehabilitation are essential components of a successful functional recovery following total hip and knee arthroplasties. Currently, we have no good measure of how mobile patients are after their surgery. Recent technological advances in personal activity monitors, such as the Fitbit, might provide medical providers and patients the opportunity to more objectively monitor their postoperative mobility and recovery course. However, these consumer activity monitors have yet to be validated in terms of their accuracy and utility for monitoring mobility in the immediate postoperative setting in arthroplasty patients. Our goal is to validate one of the most popular consumer activity monitors, the Fitbit Zip, in the postoperative total joint arthroplasty patient population.
Detailed description
Early mobilization following total hip and knee arthroplasty surgeries is important in decreasing the risk of complications such as deep venous thrombosis, pulmonary embolus, pneumonia, and urinary retention. It is also generally accepted that early mobilization may help prevent late complications such as joint stiffness or arthrofibrosis. Aside from these complications, patient satisfaction and length of hospital stay both seem to be correlated with early mobilization with poor mobility negatively impacting both outcomes. Therefore, it is important for clinicians to ensure that patients are adequately mobilizing in the immediate postoperative period to promote a successful recovery after total hip or knee arthroplasty.
Consumer activity monitors are generally manufactured to be used in a relatively healthy, ambulatory population. Their accuracy has been validated in multiple studies in healthy subjects in a variety controlled settings. Based on these validity studies, it is clear that some of these consumer activity monitors have worse accuracy in certain situations, such as slower-paced walking or in people using assistive devices for ambulation, such as canes. The limitations of these devices in these settings could be problematic for monitoring post-arthroplasty patients since all these patients ambulate slowly, with an altered gait, and with a walker. No studies to date have looked at the accuracy of consumer activity monitors in the immediate postoperative arthroplasty population.
The consumer activity monitor market is rapidly evolving and changing, so much so that monitors used just last year might be obsolete this year. Therefore, rather than examining the accuracy of one device versus another, it is more applicable to determine what location is most accurate for placement of these monitors to help providers counsel patients on proper use postoperatively.
Our goal for this study is to validate and to determine the best location for placement of the Fitbit Zip in the postoperative total joint arthroplasty patient population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fitbit | – | Other: Fitbit |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any person who is over 18 years old, a procedural candidate (having a total arthroplasty surgery at Virginia Mason Medical Center), and can understand English sufficiently to consent for the study can be included
Key inclusion criteria (7 listed)
- primary unilateral total knee arthroplasty
- ASA class I-IV
- expected to ambulate with PT on postoperative day 1 or 2
- no history of chronic opioid or alcohol use
- no history of delirium
Key exclusion criteria (5 listed)
- patient refusal,
- bilateral arthroplasty patients,
- patients who are non- ambulatory preoperatively (e.g. wheelchair bound),
- patients who are not expected to ambulate with PT either due to intraoperative or postoperative complications,
- patients with contact precautions
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 |
|---|---|---|
| FitbitFitbit use during physical therapy session | Other | Fitbit |
Primary outcome
Accuracy of Step Count Obtained from Fitbit
Time frame: Postoperative day 0-2
Comparing Fitbit step counts to observer counted steps during physical therapy sessions during inpatient stay
1 secondary outcome
Correlation of Step Count to Distance and Time Ambulated
Time frame: Postoperative day 0-2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2019.
- Individual participant dataSharing planned: No
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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.
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 Arthropathy of Knee and Arthritis Knee, run by Benaroya Research Institute at 1 site in United States.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 May 2019. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David B Auyong, MD (206-223-6980, David.Auyong@virginiamason.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Step Count Obtained from Fitbit (time frame: Postoperative day 0-2). 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 22 May 2019.