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

• Sponsor: Dr. Ho Ki Wai (Other)
• Overall Status: Completed
• CT.gov ID: NCT03492320
• Collaborator: (none)
• Enrollment: 127
• Actual Duration (Months): 45

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Knee Arthroplasty; Knee Arthroplasty, Total; Knee Replacement, Total; Replacement, Total Knee; Total Knee Replacement; Health-Related Quality Of Life; Life Quality; Osteoarthritis Of Knee	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 Design

• Study Type: Observational
• Actual Enrollment: 127 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Progression of Health Related Quality of Life of Patients Waiting for Total Knee Arthroplasty
• Actual Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Outcome Measures

Primary Outcome Measures

1. Western Ontario and McMaster University Osteoarthritis Index (WOMAC) [From March 2013 to December 2016]

   Questionnaire

2. Self-Rated Questionnaire SF36 [From March 2013 to December 2016]

   Questionnaire

3. Health Related Quality of Life (HRQoL) 15D [From March 2013 to December 2016]

   Questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Dr. Ho Ki Wai

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Ho Ki Wai, Assistant Professor, Department of Orthopaedics & Traumatology; Director of MSc/PgD Programme in Musculoskeletal Medicine & Rehabilitation, Chinese University of Hong Kong
• ClinicalTrials.gov Identifier: NCT03492320
• Other Study ID Numbers: CUHK_2013.381; CREC Ref. No.
• First Posted: Apr 10, 2018
• Last Update Posted: Apr 10, 2018
• Last Verified: Apr 1, 2018

• 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 Dr. Ho Ki Wai, Assistant Professor, Department of Orthopaedics & Traumatology; Director of MSc/PgD Programme in Musculoskeletal Medicine & Rehabilitation, Chinese University of Hong Kong: HRQoL; Quality of Life; End Stage Osteoarthritis; Total Knee Arthroplasty; WOMAC; SF 36; Total Knee Replacement
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

No Results Posted as of Apr 10, 2018