NCT03365427

Brief Summary

This study is designed to estimate the effect of an application on rehabilitation for osteoarthritis patients after total knee arthroplasty.

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
200

participants targeted

Target at 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 7, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 7, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

December 7, 2017

Status Verified

December 1, 2017

Enrollment Period

1.5 years

First QC Date

December 2, 2017

Last Update Submit

December 2, 2017

Conditions

Keywords

rehabilitationapplication on smart phones

Outcome Measures

Primary Outcomes (1)

  • The change of knee pain

    To use the Visual analogue scale (VAS) to estimate the pain of the affected knee. Its score ranges from 0 to 10, and higher score means more severe pain.

    before operation, 2 and 6 weeks after operation

Secondary Outcomes (2)

  • The change of the range of motion of affected knee

    before operation, 2 and 6 weeks after operation

  • The change of the symptoms of the affected knee

    before operation, 2 and 6 weeks after operation

Study Arms (2)

Application Group

EXPERIMENTAL

People in this arm will be introduced to an APP on smart phone, and receive lessons on how to use it on their own phones. The APP will be installed and prepare to use before surgery. People will be asked and monitored on-line to regularly use the APP.

Other: APP

Convention Group

NO INTERVENTION

People in this arm receive exactly the same treatment and lessons on post-operative rehabilitation except the reach of the APP.

Interventions

APPOTHER

An APP designed for patients experienced TKA, including on-line lessons on the action, frequency, intensity of rehabilitation exercises, and reporting system monitored by stuff from surgery team.

Application Group

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed as knee osteoarthritis with bearing X-ray
  • Education level of middle school and above
  • Prepared to take single-knee primary TKA

You may not qualify if:

  • Severe varus/valgus (over 10 degree) of affected knee before surgery
  • Stiffness of affected knee before surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Jianhao Lin, MD

    arthritis clinic and research center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The clinical professor of arthritis clinic and research center

Study Record Dates

First Submitted

December 2, 2017

First Posted

December 7, 2017

Study Start

January 7, 2018

Primary Completion

July 1, 2019

Study Completion

October 1, 2019

Last Updated

December 7, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share