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临床试验/NCT06136039
NCT06136039招募中不适用

Effect of Sarcopenia on Clinical Outcome of Total Knee Arthroplasty

Gangnam Severance Hospital2 个研究点 分布在 2 个国家目标入组 150 人开始时间: 2022年6月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
2
主要终点
ASM

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • A woman aged 60 or older who is undergoing TKA due to degenerative osteoarthritis of the knee joint at the our institution.

排除标准

  • 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.

结局指标

主要结局

ASM

时间窗: 6, 12months after surgery

Appendicular Skeletal Muscle Mass was measured through Bioelectrical Impedance Analysis.

gait speed

时间窗: 6, 12months after surgery

Gait speed was measured using a dedicated camera equipped with LiDAR sensors.

SPPB

时间窗: 6, 12months after surgery

The Short Physical Performance Battery was measured using a dedicated device that included a force plate.

handgrip strength, gait speed, SPPB, ASM)

时间窗: 6, 12months after surgery

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

次要结局

  • EQ-5D(3, 6, and 12months after surgery)
  • Knee Society Score(3, 6, and 12months after surgery)
  • WOMAC(3, 6, and 12months after surgery)
  • UCLA score(3, 6, and 12months after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Byungwoo Cho

Clinical Associate professor

Gangnam Severance Hospital

研究点 (2)

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