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CompletedNCT05346822Updated Apr 26, 2022

The Efficacy of Collaborative Patient Education on Total Knee Arthroplasty

An interventional study of integrated rehabilitation (the collaborative patient education) in Knee Arthritis, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-26.

Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Sep 2019, registered Apr 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
65 Years and older
Sex
All
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Study 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.

Read the detailed description

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.

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Conditions studied

  • Knee Arthritis

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Keywords

  • integrated rehabilitation
  • total knee arthroplasty
  • personalized medicine
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In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 70 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 281 studies on the registry; 57 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria

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

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    integrated rehabilitation program for total knee arthroplasty

    the intervention was performed in one KMUH affiliated facility

    Procedure: integrated rehabilitation (the collaborative patient education)

  • No intervention
    normal total knee arthroplasty clinical pathway

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

Interventions

  • Procedureintegrated rehabilitation (the collaborative patient education)

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

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What researchers measure

Primary outcomes

  1. Visual Analogue Pain Score (VAS)

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

    Time frame: From admission to 3 months after surgery

  2. 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.

    Time frame: From admission to 3 months after surgery

  3. 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.

    Time frame: From admission to 3 months after surgery

  4. 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.

    Time frame: From admission to 3 months after surgery

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Study locations

1 site
  • Kaohsiung Medical University Hospital
    Kaohsiung, Taiwan
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References and documents

Individual participant data

Plan to share: No — No sharing of the individual participant data

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05346822
Lead sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Responsible party
Sponsor
First posted
Apr 26, 2022
Start date
Sep 17, 2019
Primary completion
Jul 31, 2021
Completion
Jul 31, 2021
Last update
Apr 26, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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