The Outcomes of Subject After Total Knee Arthroplasty

Satisfaction, Patient Clinical Trial

Official title:

Functional Outcomes After Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05810090
• Other study ID #: 220912
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Satisfaction, Patient

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