Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Validation of Consumer Activity Monitors in Postoperative Total Arthroplasty Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03958370
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Collaborator:
Virginia Mason Hospital/Medical Center
Information provided by (Responsible Party):
Benaroya Research Institute

Brief 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.

Condition or disease Intervention/treatment
Arthropathy of Knee Arthritis Knee Arthritis, Degenerative Other: Fitbit

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
Fitbit Other: Fitbit
Fitbit use during physical therapy session




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: David B Auyong, MD 206-223-6980 David.Auyong@virginiamason.org

Locations
Layout table for location information
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         
Sponsors and Collaborators
Benaroya Research Institute
Virginia Mason Hospital/Medical Center

Layout table for additonal information
Responsible Party: Benaroya Research Institute
ClinicalTrials.gov Identifier: NCT03958370     History of Changes
Other Study ID Numbers: IRB17-053
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Benaroya Research Institute:
Fitbit
Activity Monitor
Step Count
Total Knee Replacement
Arthroplasty

Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Joint Diseases
Osteoarthritis
Musculoskeletal Diseases
Rheumatic Diseases