Clinical trial NCT06136039: Effect of Sarcopenia on Clinical Outcome of Total Knee Arthroplasty
Official title: Effect of Sarcopenia on Clinical Outcome of Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 150
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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:

1. Male
2. Under 60 years of age
3. Patients with a history of rheumatoid arthritis, traumatic joint disease, and post-infection joint disease
4. 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
5. Patients considered inappropriate for recruitment in this study based on the judgment of the research team.

Primary outcomes:
measure: handgrip strength, gait speed, SPPB, ASM)
timeFrame: 6, 12months after surgery
measure: gait speed
timeFrame: 6, 12months after surgery
measure: SPPB
timeFrame: 6, 12months after surgery
measure: ASM
timeFrame: 6, 12months after surgery
Secondary outcomes:
measure: Knee Society Score
timeFrame: 3, 6, and 12months after surgery
measure: WOMAC
timeFrame: 3, 6, and 12months after surgery
measure: EQ-5D
timeFrame: 3, 6, and 12months after surgery
measure: UCLA score
timeFrame: 3, 6, and 12months after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GangnamSeverance Hospital
Study officials:
References:
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