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Knee OsteoarthritisNCT02156453

Functional Recovery After Total Knee Arthroplasty

An observational study of Knee Osteoarthritis, run by Mahidol University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Thailand1 site
  • Siriraj Hospital

    Bangkoknoi, Bangkok, 10700

Other trials in Thailand

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.

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 groups in NCT02156453
Study groupRoleWhat they receive
Total knee arthroplastyPatients 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted5 Jun 2014 (estimated)
  2. Study startMay 2013
  3. Primary completionFeb 2018
  4. Study completionFeb 2018

Resources

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
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

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.

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