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
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring rehabilitation, application on smart phones
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
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
NCT ID
NCT03365427
First Posted
December 2, 2017
Last Updated
December 2, 2017
Sponsor
Peking University People's Hospital
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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