Knee OsteoarthritisNCT02156453
Functional Recovery After Total Knee Arthroplasty
An observational study of Knee Osteoarthritis, run by Mahidol University at 1 site in Thailand.
Trial summary
Total knee replacement is one of the most successful surgical procedures in Orthopaedics. However, 10-20% of the patients are still dissatisfied with the results of the surgery. In general, the evaluation of postoperative functional outcomes are usually measured by self-report questionnaires, such as the Western… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Total knee arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- May 2013to Feb 2018
- How long will I take part?
- 1 Year
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who receive uncomplicated total knee replacement by a single surgeon
Who may be able to join
- Patients who aged between 40-100 years
- Patients who diagnosed with end-stage osteoarthritis of the knee
Who cannot join
- Patients who receive total knee replacement on the contralateral side during the past 6 months
- Patients with diseases or conditions that may affect postoperative functional recovery such as severe cardiopulmonary disease
- Unable to participate in postoperative follow-up visits
- Prior surgery on the affected knee, such as high tibial osteotomy
- Patients with complex deformity who require bone grafting or metal augments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Evaluation of Short-term Functional Recovery of Total Knee Arthroplasty Patients
Total knee replacement is one of the most successful surgical procedures in Orthopaedics. However, 10-20% of the patients are still dissatisfied with the results of the surgery. In general, the evaluation of postoperative functional outcomes are usually measured by self-report questionnaires, such as the Western Ontario and Mcmaster Universities osteoarthritic Index (WOMAC) and the Short Form-36 health survey (SF-36). Another method to evaluate functional outcome of the patients is to use the performance-based tests such as the two-minute walk test, but there is still little information regarding its use for evaluating functional recovery in patients receiving total knee arthroplasty.
The objectives this study are: 1) to assess the relationship between self-report questionnaires and performance-based tests among patients scheduling for TKA; and 2) to identify clinical variables that are associated with pre- and postoperative functional performance of the patients.
Read the detailed description
Osteoarthritis (OA) of the knee is one of the most prevalent age-related musculoskeletal conditions, resulting in significant impairment in patients' abilities to perform activities and adversely impacting their quality of life. The level of impairment in patients with knee OA can be measured using validated self-report questionnaires, such as the disease-specific Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the generic Medical Outcomes Study Short Form-36 (SF-36). Self-report questionnaires have been recommended by some investigators for their high internal consistency and ease of administration. Another method to evaluate physical function in patients with knee OA is to use performance-based tests. These tests are tools that assess patients' ability to execute a task in a standardized environment, and include the 2-minute walk test (2MWT) and the timed get-up-and-go test (TUG).
Among all the self-reported questionnaires for knee OA, the WOMAC is one of the most commonly used for baseline assessment and for measurement of treatment outcome, and has been validated for patients undergoing total knee arthroplasty (TKA). Although the WOMAC provides information on how individuals perceive their physical function in their own environment, it does not describe their ability to perform a specific task or action. In addition, some investigators showed that scores from self-report questionnaires before and after arthroplasty can overestimate patients' actual functional capacity. For example, Parent et al demonstrated that total knee arthroplasty patients had a dramatic improvement at 2 months as assessed by the WOMAC function subscale, however there were no significant changes when measured with performance-based tests assessing gait speed and stair ascent duration. Therefore, clinicians should be cautious when interpreting findings from studies that provide only self-report questionnaire scores. Given that self-report questionnaires may over-estimate functional status after joint replacement, some authors advocate performance-based tests as measures of outcome, and recommend their use during the preoperative period as baseline measurements followed by subsequent comparison with postoperative measurements.
The objectives of this study are: 1) to assess the relationship between self-reported questionnaires (WOMAC and SF-36) and performance-based tests (2MWT, TUG) among patients scheduling for TKA; and 2) to identify clinical variables that are associated with pre- and post-operative performance of the 2MWT and TUG. Our hypothesis is that correlations between self-report questionnaires and performance-based tests would be low to moderate, and thus these two types of measurements evaluate distinct domains of functional status in patients undergoing TKA.
- Conditions
- Knee Osteoarthritis
- Being tested
- Total knee arthroplasty
- Keywords
- Functional recovery, Total knee arthroplasty
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplastyProcedure or surgery
All patients will undergo total knee replacement using midvastus approach by single surgeon.
| Study group | Role | What they receive |
|---|---|---|
| Total knee arthroplasty | Patients undergoing uncomplicated total knee replacement Receives: Procedure: Total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the 2-minute walk test (2MWT) from baseline to at 1 year after surgery
Measured: baseline, 6 weeks, 3 months, 6 months and 1 year after surgery
Secondary outcomes (4)
Change of the Timed get-up-and-go test (TUG) from baseline to 1 year after surgery
Measured: baseline, 6 weeks, 3 months, 6 months and 1 year after surgery
Change of the pain scores on the Visual Analog Scale from baseline to 1 year after surgery
Measured: baseline, 6 weeks, 3 months, 6 months and 1 year after surgery
Change of the functional scores on the WOMAC index (Thai version) from baseline to 1 year after surgery
Measured: baseline, 3 months, 6 months and 1 year after surgery
Change of the physical function domain of the SF-36 Health Survey from baseline to 1 year after surgery
Measured: baseline, 3 months, 6 months and 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startMay 2013
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aasis Unnanuntana, M.D., Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156453
- Sponsor's protocol ID
- 126/2556(EC2)
- Status last verified
- Feb 2018
- First submitted
- 2 Jun 2014
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Short-term Functional Recovery of Total Knee Arthroplasty Patients
- ClinicalTrials.gov ID
- NCT02156453
- Acronym / sponsor ID
- 126/2556(EC2)
- Conditions
- Knee Osteoarthritis
- Keywords
- Functional recovery, Total knee arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 5 Jun 2014 (estimated)
- 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 replacement is one of the most successful surgical procedures in Orthopaedics. However, 10-20% of the patients are still dissatisfied with the results of the surgery. In general, the evaluation of postoperative functional outcomes are usually measured by self-report questionnaires, such as the Western Ontario and Mcmaster Universities osteoarthritic Index (WOMAC) and the Short Form-36 health survey (SF-36). Another method to evaluate functional outcome of the patients is to use the performance-based tests such as the two-minute walk test, but there is still little information regarding its use for evaluating functional recovery in patients receiving total knee arthroplasty.
The objectives this study are: 1) to assess the relationship between self-report questionnaires and performance-based tests among patients scheduling for TKA; and 2) to identify clinical variables that are associated with pre- and postoperative functional performance of the patients.
Detailed description
Osteoarthritis (OA) of the knee is one of the most prevalent age-related musculoskeletal conditions, resulting in significant impairment in patients' abilities to perform activities and adversely impacting their quality of life. The level of impairment in patients with knee OA can be measured using validated self-report questionnaires, such as the disease-specific Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the generic Medical Outcomes Study Short Form-36 (SF-36). Self-report questionnaires have been recommended by some investigators for their high internal consistency and ease of administration. Another method to evaluate physical function in patients with knee OA is to use performance-based tests. These tests are tools that assess patients' ability to execute a task in a standardized environment, and include the 2-minute walk test (2MWT) and the timed get-up-and-go test (TUG).
Among all the self-reported questionnaires for knee OA, the WOMAC is one of the most commonly used for baseline assessment and for measurement of treatment outcome, and has been validated for patients undergoing total knee arthroplasty (TKA). Although the WOMAC provides information on how individuals perceive their physical function in their own environment, it does not describe their ability to perform a specific task or action. In addition, some investigators showed that scores from self-report questionnaires before and after arthroplasty can overestimate patients' actual functional capacity. For example, Parent et al demonstrated that total knee arthroplasty patients had a dramatic improvement at 2 months as assessed by the WOMAC function subscale, however there were no significant changes when measured with performance-based tests assessing gait speed and stair ascent duration. Therefore, clinicians should be cautious when interpreting findings from studies that provide only self-report questionnaire scores. Given that self-report questionnaires may over-estimate functional status after joint replacement, some authors advocate performance-based tests as measures of outcome, and recommend their use during the preoperative period as baseline measurements followed by subsequent comparison with postoperative measurements.
The objectives of this study are: 1) to assess the relationship between self-reported questionnaires (WOMAC and SF-36) and performance-based tests (2MWT, TUG) among patients scheduling for TKA; and 2) to identify clinical variables that are associated with pre- and post-operative performance of the 2MWT and TUG. Our hypothesis is that correlations between self-report questionnaires and performance-based tests would be low to moderate, and thus these two types of measurements evaluate distinct domains of functional status in patients undergoing TKA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total knee arthroplasty | – | Procedure: Total knee arthroplastyPatients undergoing uncomplicated total knee replacement |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who receive uncomplicated total knee replacement by a single surgeon
Key inclusion criteria (2 listed)
- Patients who aged between 40-100 years
- Patients who diagnosed with end-stage osteoarthritis of the knee
Key exclusion criteria (5 listed)
- Patients who receive total knee replacement on the contralateral side during the past 6 months
- Patients with diseases or conditions that may affect postoperative functional recovery such as severe cardiopulmonary disease
- Unable to participate in postoperative follow-up visits
- Prior surgery on the affected knee, such as high tibial osteotomy
- Patients with complex deformity who require bone grafting or metal augments
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 arthroplastyAll patients will undergo total knee replacement using midvastus approach by single surgeon. | Procedure or surgery | Total knee arthroplasty |
Primary outcome
Change of the 2-minute walk test (2MWT) from baseline to at 1 year after surgery
Time frame: baseline, 6 weeks, 3 months, 6 months and 1 year after surgery
4 secondary outcomes
Change of the Timed get-up-and-go test (TUG) from baseline to 1 year after surgery
Time frame: baseline, 6 weeks, 3 months, 6 months and 1 year after surgery
Change of the pain scores on the Visual Analog Scale from baseline to 1 year after surgery
Time frame: baseline, 6 weeks, 3 months, 6 months and 1 year after surgery
Change of the functional scores on the WOMAC index (Thai version) from baseline to 1 year after surgery
Time frame: baseline, 3 months, 6 months and 1 year after surgery
Change of the physical function domain of the SF-36 Health Survey from baseline to 1 year after surgery
Time frame: baseline, 3 months, 6 months and 1 year after surgery
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 22 Feb 2018.
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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.
Aasis Unnanuntana, M.D. principal investigator
Siriraj 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 Knee Osteoarthritis, run by Mahidol University at 1 site in Thailand.
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 2 inclusion and 5 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 22 Feb 2018. 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 Thailand. 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?
Change of the 2-minute walk test (2MWT) from baseline to at 1 year after surgery (time frame: baseline, 6 weeks, 3 months, 6 months and 1 year after surgery). 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 22 Feb 2018.