The Efficacy of Collaborative Patient Education on Total Knee Arthroplasty

NCT05346822 | Completed

• 1 other identifier: KMUHIRB-E(I)-20190255
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This project is about the integrated rehabilitation program for the patients receiving total knee arthroplasty. The investigators are monitoring the WOMAC(Western Ontario and Mcmaster University Arthritis Index)/ Pain scores/Anxiety scores/Knee society scores in the treatment course between the intervention group and the control group.

Conditions

Knee Arthritis

Keywords

integrated rehabilitation; total knee arthroplasty; personalized medicine

Outcome Measures

Primary Outcomes (4)

• Visual Analogue Pain Score (VAS)

  Minimum pain intensity from 0 to Maximum of 10. Higher scores mean a higher pain intensity.

  From admission to 3 months after surgery

• State-trait Anxiety Inventory (STAI)

  Peri-operative anxiety scoring system. STAI varies from a minimum score of 20 to a maximum score of 80. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80). Higher scores mean higher anxiety.

  From admission to 3 months after surgery

• American Knee Society Scores(AKS)

  The AKS ranges from 100 (normal knee function score) to 0 (worst knee function score). Higher scores mean a better outcome.

  From admission to 3 months after surgery

• WOMAC (Western Ontario and Mcmaster Universities Arthritis Index)

  The WOMAC evaluates 3 dimensions : pain(maximal score of 20), stiffness(maximal score of 8), and physical function(maximal score of 68). Higher scores mean worse outcomes.

  From admission to 3 months after surgery

Study Arms (2)

integrated rehabilitation program for total knee arthroplasty

EXPERIMENTAL

the intervention was performed in one KMUH affiliated facility

Procedure: integrated rehabilitation (the collaborative patient education)

normal total knee arthroplasty clinical pathway

NO INTERVENTION

no integrated rehabilitatoin program for total knee arthroplasty patients with our conventional clinical pathway

Interventions

integrated rehabilitation (the collaborative patient education) PROCEDURE

Pre-operative education and rehabilitation. During hospitalization: group rehabilitation education program. Discharge: post-operative care navigation for total knee arthroplasty

integrated rehabilitation program for total knee arthroplasty

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients over 65 years of age
• Patients scheduled to receive unilateral total knee arthroplasty due to advanced osteoarthritis
• Patients are able to understand the study and express opinions clearly
• Patients are willing to participate in this study and provide informed consents

You may not qualify if:

• Patients with inflammatory joint disease
• Patients with neurosensory system disease (such as stroke or parkinsonism)
• Patients have intellectual impairment, or dementia.

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A two-site, two-arm, parallel-group controlled trial of integrated rehabilitation program

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 26, 2022
• Study Start: September 17, 2019
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)