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Completed

NCT Number: NCT05810090

The Outcomes of Subject After Total Knee Arthroplasty

Total Knee Arthroplasty (TKA) is a standard of intervention for severe knee osteoarthritis, also been proven with benefits in improving pain, mobility, and quality of life. However, the outcomes after TKA is controversial.

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Key information

Age range

50 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Changhua Christian Hospital

Changhua, 500, Taiwan

About this study

Total Knee Arthroplasty (TKA) clinical pathway provides preoperative education, postoperative rehabilitation, and routine outpatient follow-up. The overall functional performance of the patient was assessed. The aim of this study was to analyze (1) clinical pain relief, anxiety reduction and functional recovery after TKA; (2) factors affecting individual functional recovery, such as age, gender, BMI, etc.

The results can be used as a reference for improving the quality in TKA patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • unilateral knee TKA

Exclusion criteria

  • bilateral knee TKA

Treatment and study plan

Total knee arthroplasty

Procedure

patient who received a TKA in our hospital

Primary outcomes

  1. Changes of Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    Time frame: Baseline: date of surgery (day 0); discharge from hospital (D/C), an average of 1 week; 1 month after D/C; 3 months after D/C; 6 months after D/C

    The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales:

    (I). Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright (II). Stiffness (2 items): after first waking and later in the day (III). Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties.

    The assessment was performed at: Baseline: admission date of surgery, discharge from hospital (D/C), 1 month after D/C, 3 months after D/C, 6 months after D/C

  2. Changes of knee Range of motion (ROM)

    Time frame: Baseline: date of surgery (day 0); discharge from hospital (D/C), an average of 1 week; 1 month after D/C; 3 months after D/C; 6 months after D/C

    Range of motion in bilateral Knee joints

Sponsors and collaborators

Lead sponsor

Changhua Christian Hospital

Other

Registry information

Official study title

Functional Outcomes After Total Knee Arthroplasty

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Apr 12, 2023
Registry last updated
Apr 12, 2023

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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