Validation of Consumer Activity Monitors in Postoperative Total Arthroplasty Patients
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|ClinicalTrials.gov Identifier: NCT03958370|
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
|Condition or disease||Intervention/treatment|
|Arthropathy of Knee Arthritis Knee Arthritis, Degenerative||Other: Fitbit|
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 :||Observational|
|Estimated Enrollment :||70 participants|
|Official Title:||Validation of Consumer Activity Monitors in Postoperative Total Arthroplasty Patients|
|Actual Study Start Date :||January 8, 2019|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Fitbit use during physical therapy session
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958370
|Contact: David B Auyong, MD||206-223-6980||David.Auyong@virginiamason.org|
|United States, Washington|
|Virginia Mason Medical Center||Recruiting|
|Seattle, Washington, United States, 98101|
|Contact: David B Auyong, MD 206-223-6980 David.Auyong@virginiamason.org|
|Sub-Investigator: David B Auyong, MD|
|Principal Investigator: Shin-e Lin, MD|