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Clinical Trials/NCT03365427
NCT03365427
Unknown
Not Applicable

Effect of Applications on Smart Phone on Post-operative Rehabilitation of Total Knee Arthroplasty: A Randomized Clinical Trail

Peking University People's Hospital0 sites200 target enrollmentJanuary 7, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis, Knee
Sponsor
Peking University People's Hospital
Enrollment
200
Primary Endpoint
The change of knee pain
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 7, 2018
End Date
October 1, 2019
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lin Chutong

The clinical professor of arthritis clinic and research center

Peking University People's Hospital

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

Outcomes

Primary Outcomes

The change of knee pain

Time Frame: 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 Outcomes

  • 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)

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