Progression of Health Related Quality of Life of Patients Waiting for Total Knee Arthroplasty (TKA HRQoL)

To evaluate the progression on patients suffering from end stage OA whilst being on the waiting list for TKR

Study Overview

• Status: Completed
• Conditions: Knee Arthroplasty; Knee Arthroplasty, Total; Total Knee Replacement; Osteoarthritis Of Knee; Knee Replacement, Total; Replacement, Total Knee; Health-Related Quality Of Life; Life Quality
• Intervention / Treatment: Other: Health Quality of Life Questionnaire Assessment

Detailed Description

Total Knee Arthroplasty (TKA) remains the surgical gold standard treatment for patients suffering from end stage osteoarthritis (OA) of the knee. However, due to the high demand and scarce medical resources, the waiting time for surgery is astoundingly lengthy. Controversies are shown on numerous studies on whether physical functionality and mental status decline or remain stable over the waiting period. This study aims to evaluate the progression on patients suffering from end stage OA whilst being on the waiting list for TKR.

• Study Type: Observational
• Enrollment (Actual): 127

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study aims to evaluate the progression on patients suffering from end stage OA whilst being on the waiting list for TKR. This was a prospective longitudinal study, involving patients with symptomatic osteoarthritis at Prince of Wales Hospital Hong Kong. This study was conducted from March 2013 to December 2016. By universal sampling, patients who had experienced symptomatic OA visiting the Li Ka Shing Orthopaedic Specialist out-patient clinic were screened by a research nurse or a research assistant based on the inclusion criteria.

Description

Inclusion Criteria:

1. diagnosed with symptomatic osteoarthritis
2. Enlisted on the TKA surgical waiting list
3. Ethnic Chinese
4. Fluent in Cantonese

Exclusion Criteria:

1. Evidence of cognitive dysfunction like dementia
2. Surgery scheduled within 30 days
3. Severe co-morbidity preluding participation

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)	Questionnaire	From March 2013 to December 2016
Self-Rated Questionnaire SF36	Questionnaire	From March 2013 to December 2016
Health Related Quality of Life (HRQoL) 15D	Questionnaire	From March 2013 to December 2016

Collaborators and Investigators

• Sponsor: Dr. Ho Ki Wai
• Investigators: Principal Investigator: Ki Wai Ki Wai, Dr., Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2013
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: April 3, 2018
• First Submitted That Met QC Criteria: April 3, 2018
• First Posted (Actual): April 10, 2018

Study Record Updates

• Last Update Posted (Actual): April 10, 2018
• Last Update Submitted That Met QC Criteria: April 3, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Quality of Life; SF 36; WOMAC; Total Knee Arthroplasty; Total Knee Replacement; HRQoL; End Stage Osteoarthritis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: CUHK_2013.381; CREC Ref. No. (Other Identifier: Joint CUHK-NTEC Clinical Research Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No