Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03958370
Other study ID # IRB17-053
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 8, 2019
Est. completion date December 31, 2019

Study information

Verified date May 2019
Source Benaroya Research Institute
Contact David B Auyong, MD
Phone 206-223-6980
Email David.Auyong@virginiamason.org
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design


Intervention

Other:
Fitbit
Fitbit use during physical therapy session

Locations

Country Name City State
United States Virginia Mason Medical Center Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
Benaroya Research Institute Virginia Mason Hospital/Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Accuracy of Step Count Obtained from Fitbit Comparing Fitbit step counts to observer counted steps during physical therapy sessions during inpatient stay Postoperative day 0-2
Secondary Correlation of Step Count to Distance and Time Ambulated See if Fitbit counts are more or less accurate depending on distance and time ambulated Postoperative day 0-2
See also
  Status Clinical Trial Phase
Terminated NCT03940651 - Cardiac and Renal Biomarkers in Arthroplasty Surgery Phase 4
Completed NCT05593341 - Opioid Education in Total Knee Arthroplasty N/A
Not yet recruiting NCT05290818 - Total Versus Robotic Assisted Unicompartmental Knee Replacement N/A
Withdrawn NCT04099355 - Investigating the Effect of Dronabinol on Post-surgical Pain Early Phase 1
Recruiting NCT04924205 - A Comparison Of Primary TKA Rehabilitation Using A Smart Orthotic Versus Outpatient Physical Therapy N/A
Completed NCT05399043 - Experience of Use and Biopsychosocial Effects of Robotic and Virtual Reality Devices in Neuromotor Rehabilitation N/A
Terminated NCT03185117 - Opioid Consumption After Hospital Discharge in Orthopedic Surgery
Completed NCT04118023 - 7T MRI to Evaluate Cartilage Defects in the Knee
Terminated NCT03260699 - Economic and Functional Impact of Peri-Operative Bracing for Primary Total Knee Arthroplasty (TKA) N/A
Recruiting NCT03283878 - Antibiotic Prophylaxis in Patients Undergoing Elective TKA- Multi-center Trial Phase 4
Completed NCT03133481 - Adductor Canal Block Versus Femoral Nerve Block for Total Knee Arthroplasty Phase 3
Active, not recruiting NCT04684160 - Comparison of Joint Awareness Between Fixed-bearing and Mobile-bearing Total Knee Arthroplasty Using Titanium-nitride Coated Posterior-stabilized Prostheses N/A
Completed NCT03282201 - A Survey on Blood Transfusions in Major Artrhoplasty Operations
Recruiting NCT06259032 - Comparative Effect of Mechanical and Functional Alignment in Bilateral Total Knee Arthroplasty on Ankle Alignment N/A
Completed NCT02928562 - The Impaction of Exercise Training on Bone Mineral Density in Patients After Total Knee Arthroplasty N/A
Completed NCT04481711 - Total Knee Arthroplasty and Clinical Findings N/A
Recruiting NCT01135160 - Evaluation of Weight Bearing After Total Hip and Knee Replacement
Completed NCT03921034 - IPACK Nerve Block for Total Knee Arthroplasty Phase 4
Active, not recruiting NCT05248815 - Muscle Strength and Total Knee Replacement
Not yet recruiting NCT06024161 - Weight Change and the Risk of Chronic Pain Following Hip and Knee Arthroplasties