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NCT Number: NCT06136039

Effect of Sarcopenia on Clinical Outcome of Total Knee Arthroplasty

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

GangnamSeverance Hospital

Seoul, South Korea

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Arm I (Sarcopenia)

Procedure

Same as standard treatment

Arm II(Normal)

Procedure

Same as standard treatment

Primary outcomes

  1. handgrip strength, gait speed, SPPB, ASM)

    Time frame: 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

  2. gait speed

    Time frame: 6, 12months after surgery

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

  3. SPPB

    Time frame: 6, 12months after surgery

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

  4. ASM

    Time frame: 6, 12months after surgery

    Appendicular Skeletal Muscle Mass was measured through Bioelectrical Impedance Analysis.

Secondary outcomes

  1. Knee Society Score

    Time frame: 3, 6, and 12months after surgery

    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

  2. WOMAC

    Time frame: 3, 6, and 12months after surgery

    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. EQ-5D

    Time frame: 3, 6, and 12months after surgery

    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

  4. UCLA score

    Time frame: 3, 6, and 12months after surgery

    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

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2023
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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