NCT05810090

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
631

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2017

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
Last Updated

April 12, 2023

Status Verified

October 1, 2022

Enrollment Period

5 years

First QC Date

October 30, 2022

Last Update Submit

April 10, 2023

Conditions

Keywords

Total Knee Arthroplasty (TKA)Western Ontario and McMaster Universities Arthritis Index

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

TKA (Total Knee Arthroplasty)

Patients did total knee arthroplasty in our hospital.

Procedure: Total knee arthroplasty

Interventions

patient who received a TKA in our hospital

TKA (Total Knee Arthroplasty)

Eligibility Criteria

Age50 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The data were collected from CCH2000 / TKA clinical pathway databank retrospectively.

You may qualify if:

  • unilateral knee TKA

You may not qualify if:

  • bilateral knee TKA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhua Christian Hospital

Changhua, 500, Taiwan

Location

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Chung-Che Lin, MD

    Changhua Christian Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2022

First Posted

April 12, 2023

Study Start

January 12, 2017

Primary Completion

December 31, 2021

Study Completion

January 1, 2022

Last Updated

April 12, 2023

Record last verified: 2022-10

Locations