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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
Sponsor:
Collaborator:
Virginia Mason Hospital/Medical Center
Information provided by (Responsible Party):
Benaroya Research Institute

Tracking Information
First Submitted Date May 20, 2019
First Posted Date May 22, 2019
Last Update Posted Date May 22, 2019
Actual Study Start Date January 8, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 20, 2019)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 20, 2019)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Validation of Consumer Activity Monitors in Postoperative Total Arthroplasty Patients
Official Title Validation of Consumer Activity Monitors in Postoperative Total Arthroplasty Patients
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.
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 Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Arthropathy of Knee
  • Arthritis Knee
  • Arthritis, Degenerative
Intervention Other: Fitbit
Fitbit use during physical therapy session
Study Groups/Cohorts Fitbit
Intervention: Other: Fitbit
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 20, 2019)
70
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: David B Auyong, MD 206-223-6980 David.Auyong@virginiamason.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03958370
Other Study ID Numbers IRB17-053
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Benaroya Research Institute
Study Sponsor Benaroya Research Institute
Collaborators Virginia Mason Hospital/Medical Center
Investigators Not Provided
PRS Account Benaroya Research Institute
Verification Date May 2019