Effect of Sarcopenia on Clinical Outcome of Total Knee Arthroplasty

NCT06136039 | Recruiting

• 1 other identifier: 3-2022-0137
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (4)

• 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

  6, 12months after surgery

• gait speed

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

  6, 12months after surgery

• SPPB

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

  6, 12months after surgery

• ASM

  Appendicular Skeletal Muscle Mass was measured through Bioelectrical Impedance Analysis.

  6, 12months after surgery

Secondary Outcomes (4)

• Knee Society Score

  3, 6, and 12months after surgery

• WOMAC

  3, 6, and 12months after surgery

• EQ-5D

  3, 6, and 12months after surgery

• UCLA score

  3, 6, and 12months after surgery

Study Arms (2)

Sarcopenia

EXPERIMENTAL

Patients were categorized into preoperative sarcopenia

Procedure: Arm I (Sarcopenia); Procedure: Arm II(Normal)

normal

NO INTERVENTION

normal groups according to the AWGS 2019 criteria.

Interventions

Arm I (Sarcopenia) PROCEDURE

Same as standard treatment

Sarcopenia

Arm II(Normal) PROCEDURE

Same as standard treatment

Sarcopenia

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

GangnamSeverance Hospital

Seoul, South Korea

RECRUITING

Related Publications (9)

• Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.

  PMID: 32033882 BACKGROUND

• Lopez de la Oliva AR, Campos-Sandoval JA, Gomez-Garcia MC, Cardona C, Martin-Rufian M, Sialana FJ, Castilla L, Bae N, Lobo C, Penalver A, Garcia-Frutos M, Carro D, Enrique V, Paz JC, Mirmira RG, Gutierrez A, Alonso FJ, Segura JA, Mates JM, Lubec G, Marquez J. Author Correction: Nuclear Translocation of Glutaminase GLS2 in Human Cancer Cells Associates with Proliferation Arrest and Differentiation. Sci Rep. 2021 Jan 4;11(1):249. doi: 10.1038/s41598-020-80651-0. No abstract available.

  PMID: 33397990 BACKGROUND

• Pichonnaz C, Bassin JP, Currat D, Martin E, Jolles BM. Bioimpedance for oedema evaluation after total knee arthroplasty. Physiother Res Int. 2013 Sep;18(3):140-7. doi: 10.1002/pri.1540. Epub 2012 Nov 27.

  PMID: 23188719 BACKGROUND

• Wagner DR. Case study: Effect of surgical metal implant on single frequency bioelectrical impedance measures of an athlete. Physiol Rep. 2020 Jun;8(11):e14464. doi: 10.14814/phy2.14464.

  PMID: 32472735 BACKGROUND

• Ardeljan AD, Polisetty TS, Palmer J, Vakharia RM, Roche MW. Comparative Analysis on the Effects of Sarcopenia following Primary Total Knee Arthroplasty: A Retrospective Matched-Control Analysis. J Knee Surg. 2022 Jan;35(2):128-134. doi: 10.1055/s-0040-1713355. Epub 2020 Jul 6.

  PMID: 32629511 BACKGROUND

• Babu JM, Kalagara S, Durand W, Antoci V, Deren ME, Cohen E. Sarcopenia as a Risk Factor for Prosthetic Infection After Total Hip or Knee Arthroplasty. J Arthroplasty. 2019 Jan;34(1):116-122. doi: 10.1016/j.arth.2018.09.037. Epub 2018 Sep 20.

  PMID: 30337254 BACKGROUND

• Liao CD, Chen HC, Huang SW, Liou TH. Impact of sarcopenia on rehabilitation outcomes after total knee replacement in older adults with knee osteoarthritis. Ther Adv Musculoskelet Dis. 2021 Mar 12;13:1759720X21998508. doi: 10.1177/1759720X21998508. eCollection 2021.

  PMID: 33786069 BACKGROUND

• Shin KY, Park KK, Moon SH, Yang IH, Choi HJ, Lee WS. Vitamin D deficiency adversely affects early post-operative functional outcomes after total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2017 Nov;25(11):3424-3430. doi: 10.1007/s00167-016-4209-8. Epub 2016 Jun 17.

  PMID: 27316697 BACKGROUND

• Lee WS, Park KK, Kwon HM, Park JY, Kim TH, Cho BW. A prospective, single-center longitudinal study on the operational definition of sarcopenia in patients undergoing total knee arthroplasty. Eur Geriatr Med. 2025 Nov 28. doi: 10.1007/s41999-025-01368-9. Online ahead of print.

  PMID: 41313412 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Byungwoo Cho

CONTACT

82-2-2019-3419; gsirb@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate professor

Model Details: 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.

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 18, 2023
• Study Start: June 3, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)