The Outcomes of Subject After Total Knee Arthroplasty

Sponsor
Changhua Christian Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05810090
Collaborator
(none)
631
1
59.6
10.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Total knee arthroplasty

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
631 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Functional Outcomes After Total Knee Arthroplasty
Actual Study Start Date :
Jan 12, 2017
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Jan 1, 2022

Arms and Interventions

Arm Intervention/Treatment
TKA (Total Knee Arthroplasty)

Patients did total knee arthroplasty in our hospital.

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 95 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • unilateral knee TKA
Exclusion Criteria:
  • bilateral knee TKA

Contacts and Locations

Locations

Site City State Country Postal Code
1 Changhua Christian Hospital Changhua Taiwan 500

Sponsors and Collaborators

  • Changhua Christian Hospital

Investigators

  • Principal Investigator: Chung-Che Lin, MD, Changhua Christian Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Changhua Christian Hospital
ClinicalTrials.gov Identifier:
NCT05810090
Other Study ID Numbers:
  • 220912
First Posted:
Apr 12, 2023
Last Update Posted:
Apr 12, 2023
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Changhua Christian Hospital

Study Results

No Results Posted as of Apr 12, 2023