Effect of Sarcopenia on Clinical Outcome of Total Knee Arthroplasty

Sponsor
Gangnam Severance Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06136039
Collaborator
(none)
150
1
2
24
6.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Arm I (Sarcopenia)
  • Procedure: Arm II(Normal)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
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.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)
Primary Purpose:
Treatment
Official Title:
Effect of Sarcopenia on Clinical Outcome of Total Knee Arthroplasty
Actual Study Start Date :
Jun 3, 2022
Anticipated Primary Completion Date :
Jun 3, 2024
Anticipated Study Completion Date :
Jun 3, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sarcopenia

Patients were categorized into preoperative sarcopenia

Procedure: Arm I (Sarcopenia)
Same as standard treatment

Procedure: Arm II(Normal)
Same as standard treatment

No Intervention: normal

normal groups according to the AWGS 2019 criteria.

Outcome Measures

Primary Outcome Measures

  1. handgrip strength, gait speed, SPPB, ASM) [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 [6, 12months after surgery]

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

  3. SPPB [6, 12months after surgery]

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

  4. ASM [6, 12months after surgery]

    Appendicular Skeletal Muscle Mass was measured through Bioelectrical Impedance Analysis.

Secondary Outcome Measures

  1. Knee Society Score [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 GangnamSeverance Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Gangnam Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Byungwoo Cho, Clinical Associate professor, Gangnam Severance Hospital
ClinicalTrials.gov Identifier:
NCT06136039
Other Study ID Numbers:
  • 3-2022-0137
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2023