Effect of Sarcopenia on Clinical Outcome of Total Knee Arthroplasty
ConditionKnee Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age60+
SponsorGangnam Severance Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A woman aged 60 or older who is undergoing TKA due to degenerative osteoarthritis of the knee joint at the our institution.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Arm I (Sarcopenia)
Procedure/SurgerySame as standard treatment
Arm II(Normal)
Procedure/SurgerySame as standard treatment
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: SarcopeniaExperimental treatment 2 interventions
Group B: normalNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
6, 12months after surgery2
gait speed
Gait speed was measured using a dedicated camera equipped with LiDAR sensors.
Time frame
6, 12months after surgery3
SPPB
The Short Physical Performance Battery was measured using a dedicated device that included a force plate.
Time frame
6, 12months after surgery4
ASM
Appendicular Skeletal Muscle Mass was measured through Bioelectrical Impedance Analysis.
Time frame
6, 12months after surgerySecondary outcomes
1
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
Time frame
3, 6, and 12months after surgery2
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).
Time frame
3, 6, and 12months after surgery3
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
Time frame
3, 6, and 12months after surgery4
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
Time frame
3, 6, and 12months after surgerySponsors and contacts
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Source ClinicalTrials.gov