Effect of Sarcopenia on Clinical Outcome of Total Knee Arthroplasty

Study Overview
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Brief Summary
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As human life expectancy increases, the prevalence of degenerative osteoarthritis of the knee joints is steadily rising, leading to a significant surge in the frequency of total knee arthroplasty (TKA). However, research on sarcopenia in the population that comprises the primary recipients of these orthopedic joint surgeries has been notably lacking. Since the release of the 2019 Consensus update on sarcopenia by the Asian Walking Group for Sarcopenia (AWGS) in 2020, research on sarcopenia has gained momentum in various domains. Yet, as previously mentioned, the field of orthopedics still lags behind in investigating sarcopenia. Therefore, it is believed that establishing the relationship between sarcopenia and surgical outcomes in the elderly, who are the primary targets of orthopedic joint replacement surgery, could offer insights to further enhance the results of joint replacement surgeries.

Official Title
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Effect of Sarcopenia on Clinical Outcome of Total Knee Arthroplasty

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: Arm I (Sarcopenia)
* Procedure: Arm II(Normal)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A woman aged 60 or older who is undergoing TKA due to degenerative osteoarthritis of the knee joint at the our institution. Exclusion Criteria: Male Under 60 years of age Patients with a history of rheumatoid arthritis, traumatic joint disease, and post-infection joint disease Patients who cannot undergo tests for muscle weakness diagnosis A. Patients unable to walk B. Patients unable to stand alone due to conditions like cerebral palsy or brain disorders C. Patients unable to use muscle strength Patients considered inappropriate for recruitment in this study based on the judgment of the research team.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study has prospective cohort design. Prior to surgery, a sarcopenia assessment was conducted to categorize patients into sarcopenia and normal groups. Sarcopenia was reassessed at 6 and 12 months post-surgery for comparison with the preoperative state. Additionally, clinical outcomes of patients were evaluated at 3, 6, and 12 months post-surgery for comparison between the normal and sarcopenia groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sarcopenia<br>Patients were categorized into preoperative sarcopenia | Procedure: Arm I (Sarcopenia)<br>* Same as standard treatment<br>Procedure: Arm II(Normal)<br>* Same as standard treatment<br>|
| No Intervention: normal<br>normal groups according to the AWGS 2019 criteria. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| handgrip strength, gait speed, SPPB, ASM) | Handgrip strengths were measured using a handgrip dynamometer before surgery. low muscle mass AND (low physical performance OR low strength) : sarcopenia low muscle mass AND (low physical performance AND low strength) : severe sarcopenia | 6, 12months after surgery | 
| gait speed | Gait speed was measured using a dedicated camera equipped with LiDAR sensors. | 6, 12months after surgery | 
| SPPB | The Short Physical Performance Battery was measured using a dedicated device that included a force plate. | 6, 12months after surgery | 
| ASM | Appendicular Skeletal Muscle Mass was measured through Bioelectrical Impedance Analysis. | 6, 12months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Score | The original KSS has a Knee Score section (7 items) and a Functional Score section (3 items). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions | 3, 6, and 12months after surgery | 
| WOMAC | Higher scores indicate worse pain, stiffness, and functional limitations. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). | 3, 6, and 12months after surgery | 
| EQ-5D | The EuroQol 5 Dimension (EQ-5D) is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression | 3, 6, and 12months after surgery | 
| UCLA score | The UCLA Activity Scale (UCLA) is a questionnaire assessing physical activity level from 1 (low) to 10 (high) in patients undergoing hip or knee arthroplasty | 3, 6, and 12months after surgery |