Knee ArthroplastyTKA HRQoLNCT03492320
Progression of Health Related Quality of Life of Patients Waiting for Total Knee Arthroplasty
An observational study of Knee Arthroplasty and Knee Arthroplasty, Total, run by Dr. Ho Ki Wai.
Trial summary
To evaluate the progression on patients suffering from end stage OA whilst being on the waiting list for TKR Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Arthroplasty, Knee Arthroplasty, Total, Knee Replacement, Total
- What is being tested?
- Health Quality of Life Questionnaire Assessment
- How many people
- 127 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2013to 1 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- diagnosed with symptomatic osteoarthritis
- Enlisted on the TKA surgical waiting list
- Ethnic Chinese
- Fluent in Cantonese
Who cannot join
- Evidence of cognitive dysfunction like dementia
- Surgery scheduled within 30 days
- Severe co-morbidity preluding participation
About this study
To evaluate the progression on patients suffering from end stage OA whilst being on the waiting list for TKR
Read the 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.
- Conditions
- Knee Arthroplasty, Knee Arthroplasty, Total, Knee Replacement, Total, Replacement, Total Knee, Total Knee Replacement, Health-Related Quality Of Life
- Being tested
- Health Quality of Life Questionnaire Assessment
- Keywords
- HRQoL, Quality of Life, End Stage Osteoarthritis, Total Knee Arthroplasty, WOMAC, SF 36, Total Knee Replacement
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Quality of Life Questionnaire AssessmentOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Questionnaire
Measured: From March 2013 to December 2016
Self-Rated Questionnaire SF36
Questionnaire
Measured: From March 2013 to December 2016
Health Related Quality of Life (HRQoL) 15D
Questionnaire
Measured: From March 2013 to December 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start1 Mar 2013
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Ho Ki Wai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Ho Ki Wai, Chinese University of Hong Kong
- Investigators
- Ki Wai Ki Wai, Dr., Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492320
- Sponsor's protocol ID
- CUHK_2013.381
- Other IDs
- CREC Ref. No.
- Acronym
- TKA HRQoL
- Status last verified
- Apr 2018
- First submitted
- 3 Apr 2018
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progression of Health Related Quality of Life of Patients Waiting for Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03492320
- Acronym / sponsor ID
- TKA HRQoL / CUHK_2013.381
- Conditions
- Knee Arthroplasty, Knee Arthroplasty, Total, Knee Replacement, Total, Replacement, Total Knee, Total Knee Replacement, Health-Related Quality Of Life
- Keywords
- HRQoL, Quality of Life, End Stage Osteoarthritis, Total Knee Arthroplasty, WOMAC, SF 36, Total Knee Replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Dr. Ho Ki WaiUniversity, hospital or other
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the progression on patients suffering from end stage OA whilst being on the waiting list for TKR
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- diagnosed with symptomatic osteoarthritis
- Enlisted on the TKA surgical waiting list
- Ethnic Chinese
- Fluent in Cantonese
Key exclusion criteria (3 listed)
- Evidence of cognitive dysfunction like dementia
- Surgery scheduled within 30 days
- Severe co-morbidity preluding participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Quality of Life Questionnaire AssessmentWestern 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. | Other | – |
Primary outcome
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Time frame: From March 2013 to December 2016
Questionnaire
Self-Rated Questionnaire SF36
Time frame: From March 2013 to December 2016
Questionnaire
Health Related Quality of Life (HRQoL) 15D
Time frame: From March 2013 to December 2016
Questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ki Wai Ki Wai, Dr. principal investigator
Chinese University of Hong Kong
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Arthroplasty and Knee Arthroplasty, Total, run by Dr. Ho Ki Wai.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster University Osteoarthritis Index (WOMAC) (time frame: From March 2013 to December 2016). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2018.