Comparison of Functional Recovery After Total Knee Arthroplasty Between Low Phase Angle and High Phase Angle Group
NCT ID: NCT06701474
Last Updated: 2025-02-07
Study Results
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Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2024-09-13
2025-09-23
Brief Summary
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The main questions it aims to answer are:
* Do patients with low phase angle show worse functional recovery after total knee arthroplasty compared to those with high phase angle?
* Is postoperative physical function associated with preoperative phase angle level?
Researchers will compare postoperative physical function and muscle strength between the low and high phase angle groups to determine whether a low phase angle is associated with poorer functional recovery.
Participants will:
Perform physical function tests, isokinetic strength assessments, and bioelectrical impedance analysis before and three months after surgery.
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Detailed Description
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The screening includes a comprehensive evaluation of baseline symptoms, followed by functional assessments that incorporate bioelectrical impedance analysis, muscle strength testing, and performance-based tests:
* A modified Charlson Comorbidity Index (CCI) is used to assess comorbidity burden, and a Numeric Pain Rating Scale (NPRS) records participants' initial pain levels.
* Radiographic assessments are performed to evaluate the frontal alignment of the lower extremities and the radiographic severity of knee osteoarthritis (OA) using the Kellgren-Lawrence (K-L) grading system.
* Multifrequency bioelectrical impedance analysis (BIA) is used to measure phase angle and body composition.
* Handgrip strength is measured through three trials on each side, with the average recorded.
* Knee strength is measured using an isokinetic dynamometer.
* Performance-based tests include the 10-meter walk test, the Timed Up and Go (TUG) test, and the Berg Balance Scale (BBS).
Follow-up assessments are conducted three months after total knee arthroplasty, with participants undergoing the same protocol for performance-based tests, isokinetic knee strength evaluation, and bioelectrical impedance analysis.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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high PhA
* Patients diagnosed with knee osteoarthritis and scheduled for total knee arthroplasty.
* Among these, patients are classified into the high PhA group if their preoperative PhA is above 4.95 for males or 4.35 for females
No interventions assigned to this group
low PhA
* Patients diagnosed with knee osteoarthritis and scheduled for total knee arthroplasty.
* Among these, patients are classified into the low PhA group if their preoperative PhA is below 4.95 for males or 4.35 for females
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Individuals diagnosed with knee OA based on medical history, physical examination, and radiographic assessments.
* Individuals who plan to perform total knee arthroplasty
Exclusion Criteria
* Individuals with severe cardiac, pulmonary, or musculoskeletal disorders that limited quadriceps strength and physical function
* Individuals with knee osteoarthritis due to secondary causes such as rheumatic or traumatic arthritis
* Individuals with a history of any knee surgery within one year.
* Individuals considered clinically unsuitable for the study by the researchers or person in charge based on significant medical findings.
55 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Yongin Severance Hospital
Yongin-si, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Uemura K, Doi T, Tsutsumimoto K, Nakakubo S, Kim MJ, Kurita S, Ishii H, Shimada H. Predictivity of bioimpedance phase angle for incident disability in older adults. J Cachexia Sarcopenia Muscle. 2020 Feb;11(1):46-54. doi: 10.1002/jcsm.12492. Epub 2019 Aug 22.
Martins PC, Alves Junior CAS, Silva AM, Silva DAS. Phase angle and body composition: A scoping review. Clin Nutr ESPEN. 2023 Aug;56:237-250. doi: 10.1016/j.clnesp.2023.05.015. Epub 2023 Jun 1.
Stapel SN, Looijaard WGPM, Dekker IM, Girbes ARJ, Weijs PJM, Oudemans-van Straaten HM. Bioelectrical impedance analysis-derived phase angle at admission as a predictor of 90-day mortality in intensive care patients. Eur J Clin Nutr. 2018 Jul;72(7):1019-1025. doi: 10.1038/s41430-018-0167-1. Epub 2018 May 11.
Sardinha LB, Rosa GB. Phase angle, muscle tissue, and resistance training. Rev Endocr Metab Disord. 2023 Jun;24(3):393-414. doi: 10.1007/s11154-023-09791-8. Epub 2023 Feb 10.
Harris IA, Harris AM, Naylor JM, Adie S, Mittal R, Dao AT. Discordance between patient and surgeon satisfaction after total joint arthroplasty. J Arthroplasty. 2013 May;28(5):722-7. doi: 10.1016/j.arth.2012.07.044. Epub 2013 Feb 23.
Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. doi: 10.1007/s11999-009-1119-9.
Capin JJ, Bade MJ, Jennings JM, Snyder-Mackler L, Stevens-Lapsley JE. Total Knee Arthroplasty Assessments Should Include Strength and Performance-Based Functional Tests to Complement Range-of-Motion and Patient-Reported Outcome Measures. Phys Ther. 2022 Jun 3;102(6):pzac033. doi: 10.1093/ptj/pzac033.
Wieczorek M, Rotonda C, Guillemin F, Rat AC. What Have We Learned About the Course of Clinical Outcomes After Total Knee or Hip Arthroplasty? Arthritis Care Res (Hoboken). 2020 Nov;72(11):1519-1529. doi: 10.1002/acr.24045.
GBD 2021 Osteoarthritis Collaborators. Global, regional, and national burden of osteoarthritis, 1990-2020 and projections to 2050: a systematic analysis for the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023 Aug 21;5(9):e508-e522. doi: 10.1016/S2665-9913(23)00163-7. eCollection 2023 Sep.
Other Identifiers
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9-2024-0150
Identifier Type: -
Identifier Source: org_study_id
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