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Post-operative Rehabilitation of Total Knee Arthroplasty With Applications on Smart Phone

Primary Purpose

Osteoarthritis, Knee, Arthropathy of Knee

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
APP
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring rehabilitation, application on smart phones

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Application Group

    Convention Group

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    The change of the range of motion of affected knee
    Use a goniometer to mesrange of motion of affected knee
    The change of the symptoms of the affected knee
    To use the knee society score to estimate the symptoms of the affected knee.Its score ranges from 0 to 100, and higher score means more severe symptoms.

    Full Information

    First Posted
    December 2, 2017
    Last Updated
    December 2, 2017
    Sponsor
    Peking University People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03365427
    Brief Title
    Post-operative Rehabilitation of Total Knee Arthroplasty With Applications on Smart Phone
    Official Title
    Effect of Applications on Smart Phone on Post-operative Rehabilitation of Total Knee Arthroplasty: A Randomized Clinical Trail
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 7, 2018 (Anticipated)
    Primary Completion Date
    July 1, 2019 (Anticipated)
    Study Completion Date
    October 1, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking University People's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study is designed to estimate the effect of an application on rehabilitation for osteoarthritis patients after total knee arthroplasty.
    Detailed Description
    Apart from surgical technique, the outcome of total knee arthroplasty (TKA) also largely depend on adequate rehabilitation and subsequent functional recovery after surgery.Rehabilitation affects or even determines various performance of post-operative knee, including knee range-of-motion (ROM), muscle strength, functional independence, all of which subsequently affect patients' quality of life. Conventional way of rehabilitation is exercise therapy, which rely on guidance of therapists and the self-efficacy of patients. An application (APP) on smart phone was designed for people received TKA to play the role of guider and help improving patients' self-efficacy. This is a single-centre randomized clinical trial, with an anticipation of 200 patients with knee osteoarthritis enrolled, who will be randomly assigned into experiment group or control group. The patients in the experiment group will be introduced to this APP and requested to use it regularly, while the patients in the control group will receive pure conventional rehabilitation. Primary outcome includes Visual analogue scale (VAS) of pain, knee society score (KSS), ROM, ability of daily living (ADL) before operation and at 2 weeks and 6 weeks after surgery. All potential covariates of those two groups, such as age, sex, and pre-operative kellgren-lawrence scores would be matched by completely randomize.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Knee, Arthropathy of Knee
    Keywords
    rehabilitation, application on smart phones

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Application Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Convention Group
    Arm Type
    No Intervention
    Arm Description
    People in this arm receive exactly the same treatment and lessons on post-operative rehabilitation except the reach of the APP.
    Intervention Type
    Other
    Intervention Name(s)
    APP
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    The change of knee pain
    Description
    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.
    Time Frame
    before operation, 2 and 6 weeks after operation
    Secondary Outcome Measure Information:
    Title
    The change of the range of motion of affected knee
    Description
    Use a goniometer to mesrange of motion of affected knee
    Time Frame
    before operation, 2 and 6 weeks after operation
    Title
    The change of the symptoms of the affected knee
    Description
    To use the knee society score to estimate the symptoms of the affected knee.Its score ranges from 0 to 100, and higher score means more severe symptoms.
    Time Frame
    before operation, 2 and 6 weeks after operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosed as knee osteoarthritis with bearing X-ray Education level of middle school and above Prepared to take single-knee primary TKA Exclusion Criteria: Severe varus/valgus (over 10 degree) of affected knee before surgery Stiffness of affected knee before surgery
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chutong Lin
    Phone
    +86 15652930253
    Email
    chutonglin@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jianhao Lin, MD
    Organizational Affiliation
    arthritis clinic and research center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Post-operative Rehabilitation of Total Knee Arthroplasty With Applications on Smart Phone

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