Recruiting

Observational Study

Sponsor:

Benaroya Research Institute

Code:

NCT03958370

Conditions

Arthropathy of Knee

Arthritis Knee

Arthritis, Degenerative

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Fitbit

Study Details

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

Study ID

NCT03958370

Start date

Jan 8, 2019

Status verified date

May, 2019

Completion date

Dec 31, 2019

Anticipated

Primary completion date

Dec 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

70 participants

Anticipated

Interventions and Outcome Measures

Arms

Fitbit

Interventions

Fitbit

Fitbit use during physical therapy session

Primary outcome measure

  • Accuracy of Step Count Obtained from Fitbit [ Time Frame: Postoperative day 0-2 ]

Central Contacts and Locations

Central contacts

David B Auyong, MD

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

Locations

Virginia Mason Medical Center

Recruiting

Seattle, Washington, United States, 98101

Contacts

David B Auyong, MD

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

Principal Investigator:

Shin-e Lin, MD

More Information

Sponsor

Benaroya Research Institute

Last update posted

May 22, 2019

Last verified

May, 2019

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Benaroya Research Institute on 2019-05-22.