Satisfaction, PatientNCT05810090
The Outcomes of Subject After Total Knee Arthroplasty
An observational study of Satisfaction, Patient, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 95 years
- Conditions the study is for
- Satisfaction, Patient
- What is being tested?
- Total knee arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 631 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Jan 2017to 1 Jan 2022
- 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 50 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The data were collected from CCH2000 / TKA clinical pathway databank retrospectively.
Who may be able to join
- unilateral knee TKA
Who cannot join
- bilateral knee TKA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Outcomes After Total Knee Arthroplasty
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.
Read the detailed description
Total Knee Arthroplasty (TKA) clinical pathway provides preoperative education, postoperative rehabilitation, and routine outpatient follow-up. The overall functional performance of the patient was assessed. The aim of this study was to analyze (1) clinical pain relief, anxiety reduction and functional recovery after TKA; (2) factors affecting individual functional recovery, such as age, gender, BMI, etc.
The results can be used as a reference for improving the quality in TKA patients.
- Conditions
- Satisfaction, Patient
- Being tested
- Total knee arthroplasty
- Keywords
- Total Knee Arthroplasty (TKA), Western Ontario and McMaster Universities Arthritis Index
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplastyProcedure or surgery
patient who received a TKA in our hospital
| Study group | Role | What they receive |
|---|---|---|
| TKA (Total Knee Arthroplasty) | Patients did total knee arthroplasty in our hospital. Receives: Procedure: Total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start12 Jan 2017
- Primary completion31 Dec 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Satisfaction, PatientStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 631 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chung-Che Lin, MD, Principal investigator, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810090
- Sponsor's protocol ID
- 220912
- Status last verified
- Oct 2022
- First submitted
- 30 Oct 2022
- Last updated
- 12 Apr 2023
- 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 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcomes After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05810090
- Acronym / sponsor ID
- 220912
- Conditions
- Satisfaction, Patient
- Keywords
- Total Knee Arthroplasty (TKA), Western Ontario and McMaster Universities Arthritis Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 631 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- 12 Jan 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 12 Apr 2023 (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.
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.
Detailed description
Total Knee Arthroplasty (TKA) clinical pathway provides preoperative education, postoperative rehabilitation, and routine outpatient follow-up. The overall functional performance of the patient was assessed. The aim of this study was to analyze (1) clinical pain relief, anxiety reduction and functional recovery after TKA; (2) factors affecting individual functional recovery, such as age, gender, BMI, etc.
The results can be used as a reference for improving the quality in TKA patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TKA (Total Knee Arthroplasty) | – | Procedure: Total knee arthroplastyPatients did total knee arthroplasty in our hospital. |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The data were collected from CCH2000 / TKA clinical pathway databank retrospectively.
Key inclusion criteria (1 listed)
- unilateral knee TKA
Key exclusion criteria (1 listed)
- bilateral knee TKA
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 |
|---|---|---|
| Total knee arthroplastypatient who received a TKA in our hospital | Procedure or surgery | TKA (Total Knee Arthroplasty) |
Primary outcome
Changes of Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 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
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
Changes of knee Range of motion (ROM)
Time frame: 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
Range of motion in bilateral Knee joints
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 12 Apr 2023.
- 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.
Chung-Che Lin, MD principal investigator
Changhua Christian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Satisfaction, Patient, run by Changhua Christian Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Changes of Western Ontario and McMaster Universities Arthritis Index (WOMAC) (time frame: 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). The study lists 2 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 12 Apr 2023.