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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03365427
• Other study ID #: PUPH20170917
• Status: Not yet recruiting
• Phase: N/A
• First received: December 2, 2017
• Last updated: December 2, 2017
• Start date: January 7, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: December 2017
• Source: Peking University People's Hospital
• Contact: Chutong Lin
• Phone: +86 15652930253
• Email: chutonglin[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: October 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthropathy of Knee
• Joint Diseases
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• APP
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The change of the range of motion of affected knee	Use a goniometer to mesrange of motion of affected knee	before operation, 2 and 6 weeks after operation
Secondary	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.	before operation, 2 and 6 weeks after operation