- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03958370
Validation of Consumer Activity Monitors in Postoperative Total Arthroplasty Patients
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: David B Auyong, MD
- Phone Number: 206-223-6980
- Email: David.Auyong@virginiamason.org
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98101
- Recruiting
- Virginia Mason Medical Center
-
Contact:
- David B Auyong, MD
- Phone Number: 206-223-6980
- Email: David.Auyong@virginiamason.org
-
Sub-Investigator:
- David B Auyong, MD
-
Principal Investigator:
- Shin-e Lin, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Fitbit
|
Fitbit use during physical therapy session
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Postoperative day 0-2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation of Step Count to Distance and Time Ambulated
Time Frame: Postoperative day 0-2
|
See if Fitbit counts are more or less accurate depending on distance and time ambulated
|
Postoperative day 0-2
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB17-053
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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