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Completed

NCT Number: NCT05346822

The Efficacy of Collaborative Patient Education on Total Knee Arthroplasty

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.

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Key information

Conditions

Knee Arthritis

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

About this study

This is a quasi-experimental design study. The participants received total knee arthroplasty by one single surgeon in two facilities within the same medical system (Kaohsiung Medical University affiliated hospitals). The intervention groups received integrated rehabilitation program including verbal one-on-one education, personalized post-operation rehabilitation during admission and scheduled post-operation follow up by a nurse case manager. The control group received the same surgery with traditional clinical pathway by the single surgeon in another affiliated hospital.

We recorded the pain scores, state-trait anxiety inventory scores, WOMAC(Western Ontario and Mcmaster Universities Arthritis Index) scores, American Knee society scores for these participants.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

  1. Visual Analogue Pain Score (VAS)

    Time frame: From admission to 3 months after surgery

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

  2. State-trait Anxiety Inventory (STAI)

    Time frame: From admission to 3 months after surgery

    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.

  3. American Knee Society Scores(AKS)

    Time frame: From admission to 3 months after surgery

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

  4. WOMAC (Western Ontario and Mcmaster Universities Arthritis Index)

    Time frame: From admission to 3 months after surgery

    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.

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study title

The Effects of a Patient-specific Integrated Education Program on Pain, Perioperative Anxiety, and Functional Recovery Following Total Knee Replacement

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 26, 2022
Registry last updated
Apr 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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