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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03492320
Other study ID # CUHK_2013.381
Secondary ID CREC Ref. No.
Status Completed
Phase
First received April 3, 2018
Last updated April 3, 2018
Start date March 1, 2013
Est. completion date December 1, 2016

Study information

Verified date April 2018
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 127
Est. completion date December 1, 2016
Est. primary completion date December 1, 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

Other:
Health Quality of Life Questionnaire Assessment
Western Ontario and McMaster University Osteoarthritis Index (WOMAC), Self-Rated Questionnaire SF36 and Health Related Quality of Life (HRQoL) 15D questionnaire were used as outcome measurement for functionality and disability assessment.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Dr. Ho Ki Wai

Outcome

Type Measure Description Time frame Safety issue
Primary Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Questionnaire From March 2013 to December 2016
Primary Self-Rated Questionnaire SF36 Questionnaire From March 2013 to December 2016
Primary Health Related Quality of Life (HRQoL) 15D Questionnaire From March 2013 to December 2016
See also
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Completed NCT01515449 - Predictors of Poor Outcomes in 1038 Sigma Knees N/A
Completed NCT01522781 - 10 Year Outcome of Total Knee Replacement (TKR) Using Sigma Prosthesis N/A
Completed NCT04166539 - Neurotoxicity and Cardiotoxicity in Total Joint Arthroplasty
Completed NCT03454256 - Virtual Reality Rehabilitation in Patients With Total Knee Replacement N/A
Enrolling by invitation NCT06118073 - Effect of Mindfulness on Pain After Total Knee Arthroplasty N/A