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

NCT ID: NCT03365427

Last Updated: 2017-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-07

Study Completion Date

2019-10-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Osteoarthritis, Knee Arthropathy of Knee

Keywords

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rehabilitation application on smart phones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

APP

Intervention Type OTHER

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.

Convention Group

People in this arm receive exactly the same treatment and lessons on post-operative rehabilitation except the reach of the APP.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lin Chutong

The clinical professor of arthritis clinic and research center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jianhao Lin, MD

Role: PRINCIPAL_INVESTIGATOR

arthritis clinic and research center

Central Contacts

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Chutong Lin

Role: CONTACT

Phone: +86 15652930253

Email: [email protected]

Other Identifiers

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PUPH20170917

Identifier Type: -

Identifier Source: org_study_id