NCT03368287

Brief Summary

This study aims to estimated the change of the steps of daily life of osteoarthritis patients before and in 6 weeks, 3 months, 6 months, 1 year after the total knee arthroplasty (TKA) through a kind of activity tracker: Fitbit ONE.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 11, 2017

Completed
21 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

December 11, 2017

Status Verified

December 1, 2017

Enrollment Period

1.1 years

First QC Date

November 25, 2017

Last Update Submit

December 5, 2017

Conditions

Keywords

Total Knee Arthroplastystepsrehabilitationactivity tracker

Outcome Measures

Primary Outcomes (1)

  • The change of steps of daily life

    steps

    before operation and 6 weeks, 3 months, 6 months, 1 year after operation

Secondary Outcomes (2)

  • The change of pain score

    before operation and 6 weeks, 3 months, 6 months, 1 year after operation

  • The change of knee joint symptoms.

    before operation and 6 weeks, 3 months, 6 months, 1 year after operation

Study Arms (1)

activity tracker

EXPERIMENTAL

In this study, Fitbit One, the activity tracker, will be used for every participants to evaluate the daily steps before and after surgery for one year

Device: Fitbit One, the activity tracker

Interventions

Activity tracker, Fitbit One, will be used for a week to evaluate the steps of daily life before the surgery and at the time of follow up.

activity tracker

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ready to receive single-side TKA

You may not qualify if:

  • contraindication of surgery
  • self-reported diseases that cause lower limb disability (for example, cerebrovascular disease especially stroke)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Patel S, Park H, Bonato P, Chan L, Rodgers M. A review of wearable sensors and systems with application in rehabilitation. J Neuroeng Rehabil. 2012 Apr 20;9:21. doi: 10.1186/1743-0003-9-21.

    PMID: 22520559BACKGROUND
  • Kooiman TJ, Dontje ML, Sprenger SR, Krijnen WP, van der Schans CP, de Groot M. Reliability and validity of ten consumer activity trackers. BMC Sports Sci Med Rehabil. 2015 Oct 12;7:24. doi: 10.1186/s13102-015-0018-5. eCollection 2015.

    PMID: 26464801BACKGROUND
  • Cook DJ, Thompson JE, Prinsen SK, Dearani JA, Deschamps C. Functional recovery in the elderly after major surgery: assessment of mobility recovery using wireless technology. Ann Thorac Surg. 2013 Sep;96(3):1057-61. doi: 10.1016/j.athoracsur.2013.05.092.

    PMID: 23992697BACKGROUND

Study Officials

  • Jianhao Lin, MD

    arthritic clinic and research center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The clinical professor of arthritis clinic and research center

Study Record Dates

First Submitted

November 25, 2017

First Posted

December 11, 2017

Study Start

January 1, 2018

Primary Completion

January 30, 2019

Study Completion

January 31, 2019

Last Updated

December 11, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share