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RecruitingNCT06136039Updated Jul 19, 2024

Effect of Sarcopenia on Clinical Outcome of Total Knee Arthroplasty

An interventional study of Arm I (Sarcopenia) and Arm II(Normal) in Knee Osteoarthritis, sponsored by Gangnam Severance Hospital. Recruiting at 1 site in Korea, Republic of. Open to female participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-07-19.

Sponsored by Gangnam Severance Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Registered 1 year 5 months after the study started (first participant enrolled Jun 2022, registered Nov 2023).
  • Started Jun 2022; still recruiting 4 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Non-randomized
Ages
60 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Knee Osteoarthritis

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03

In context

Sarcopenia

1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.

This study's planned enrollment of 150 is above the median of 60 across 775 interventional studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

Gangnam Severance Hospital is the lead sponsor of 141 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Sarcopenia

    Patients were categorized into preoperative sarcopenia

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

  • No intervention
    normal

    normal groups according to the AWGS 2019 criteria.

Interventions

  • ProcedureArm I (Sarcopenia)

    Same as standard treatment

  • ProcedureArm II(Normal)

    Same as standard treatment

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 6, 12months after surgery

  2. gait speed

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

    Time frame: 6, 12months after surgery

  3. SPPB

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

    Time frame: 6, 12months after surgery

  4. ASM

    Appendicular Skeletal Muscle Mass was measured through Bioelectrical Impedance Analysis.

    Time frame: 6, 12months after surgery

Secondary outcomes

  1. 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

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

  2. 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).

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

  3. 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

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

  4. 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

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

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Study locations

1 of 1 sites recruiting
  • GangnamSeverance Hospital
    Seoul, Korea, Republic of
    Recruiting
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References and documents

Publications

  • 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. PubMed 32033882 ↗
  • 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. PubMed 33397990 ↗
  • 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. PubMed 23188719 ↗
  • 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. PubMed 32472735 ↗
  • 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. PubMed 32629511 ↗
  • 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. PubMed 30337254 ↗
  • 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. PubMed 33786069 ↗
  • 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. PubMed 27316697 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06136039
Lead sponsor
Gangnam Severance Hospital
Responsible party
Byungwoo Cho (Clinical Associate professor, Gangnam Severance Hospital) — Principal investigator
First posted
Nov 18, 2023
Start date
Jun 3, 2022
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Jul 19, 2024

Study contacts

Byungwoo Cho
Contact
gsirb@yuhs.ac
82-2-2019-3419

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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