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

Not Applicable

• Conditions: Osteoarthritis, Knee; Arthropathy of Knee
• Interventions: Other: APP

• Registration Number: NCT03365427
• Lead Sponsor: Peking University People's Hospital

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.

Study Timeline

• Status Verified: 2017-12
• Study First Submitted: 2017-12-02
• Study First Submitted QC: 2017-12-02
• Last Update Submitted: 2017-12-02
• Study First Posted: 2017-12-07
• Last Update Posted: 2017-12-07
• Study Start: 2018-01-07
• Primary Completion: 2019-07-01
• Study Completion: 2019-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Application Group	APP	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.

Primary Outcome Measures

Name	Time	Method
The change of knee pain	before operation, 2 and 6 weeks after operation	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

Name	Time	Method
The change of the range of motion of affected knee	before operation, 2 and 6 weeks after operation	Use a goniometer to mesrange of motion of affected knee
The change of the symptoms of the affected knee	before operation, 2 and 6 weeks after operation	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.