Validation of Consumer Activity Monitors in Postoperative Total Arthroplasty Patients

NCT03958370 | Unknown

• 1 other identifier: IRB17-053
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthropathy of Knee; Arthritis Knee; Arthritis, Degenerative

Keywords

Fitbit; Activity Monitor; Step Count; Total Knee Replacement; Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation of Step Count to Distance and Time Ambulated

  Postoperative day 0-2

Study Arms (1)

Fitbit

Other: Fitbit

Interventions

Fitbit OTHER

Fitbit use during physical therapy session

Fitbit

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Benaroya Research Institute: lead
• Virginia Mason Hospital/Medical Center: collaborator

Study Sites (1)

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

David B Auyong, MD

CONTACT

206-223-6980; David.Auyong@virginiamason.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: May 22, 2019
• Study Start: January 8, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: May 22, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)