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

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

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

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis, Knee; Arthropathy of Knee
• Intervention / Treatment: Other: APP

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chutong Lin; Phone Number: +86 15652930253; Email: chutonglin@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Application Group; 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.	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.
No Intervention: Convention Group; People in this arm receive exactly the same treatment and lessons on post-operative rehabilitation except the reach of the APP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Principal Investigator: Jianhao Lin, MD, arthritis clinic and research center

Study record dates

Study Major Dates

• Study Start (Anticipated): January 7, 2018
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: December 2, 2017
• First Submitted That Met QC Criteria: December 2, 2017
• First Posted (Actual): December 7, 2017

Study Record Updates

• Last Update Posted (Actual): December 7, 2017
• Last Update Submitted That Met QC Criteria: December 2, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: rehabilitation; application on smart phones
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: PUPH20170917

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No