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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05810090
Other study ID # 220912
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 12, 2017
Est. completion date January 1, 2022

Study information

Verified date October 2022
Source Changhua Christian Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 631
Est. completion date January 1, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 50 Years to 95 Years
Eligibility Inclusion Criteria: - unilateral knee TKA Exclusion Criteria: - bilateral knee TKA

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Total knee arthroplasty
patient who received a TKA in our hospital

Locations

Country Name City State
Taiwan Changhua Christian Hospital Changhua

Sponsors (1)

Lead Sponsor Collaborator
Changhua Christian Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes of Western Ontario and McMaster Universities Arthritis Index (WOMAC) 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
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
Primary Changes of knee Range of motion (ROM) Range of motion in bilateral Knee joints 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
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