Effect of Sarcopenia on Clinical Outcome of Total Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

Official title:

Effect of Sarcopenia on Clinical Outcome of Total Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06136039
• Other study ID #: 3-2022-0137
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2022
• Est. completion date: June 3, 2024

Study information

• Verified date: November 2023
• Source: Gangnam Severance Hospital
• Contact: Byungwoo Cho
• Phone: 82-2-2019-3419
• Email: gsirb[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 3, 2024
• Est. primary completion date: June 3, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Sarcopenia

Intervention

Procedure:
• Arm I (Sarcopenia)
Same as standard treatment
• Arm II(Normal)
Same as standard treatment

Locations

Country	Name	City	State
Korea, Republic of	GangnamSeverance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	gait speed	Gait speed was measured using a dedicated camera equipped with LiDAR sensors.	6, 12months after surgery
Primary	SPPB	The Short Physical Performance Battery was measured using a dedicated device that included a force plate.	6, 12months after surgery
Primary	ASM	Appendicular Skeletal Muscle Mass was measured through Bioelectrical Impedance Analysis.	6, 12months after surgery
Secondary	Knee Society Score	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	3, 6, and 12months after surgery
Secondary	WOMAC	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, 6, and 12months after surgery
Secondary	EQ-5D	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	3, 6, and 12months after surgery
Secondary	UCLA score	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	3, 6, and 12months after surgery