Comparison of Functional Recovery After Total Knee Arthroplasty Between Low Phase Angle and High Phase Angle Group

Официальное название

Association Between Phase Angle and Functional Recovery After Total Knee Arthroplasty

Обзор

The goal of this observational study is to compare the functional outcome of patients with end-stage knee osteoarthritis (OA) before and after total knee arthroplasty based on the phase angle level. 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.

Подробное описание

After obtaining informed consent, a pre-surgical screening is conducted. Participants complete a history survey, a sarcopenia questionnaire, and the International Physical Activity Questionnaire (IPAQ).

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.

Первичные конечные точки

• Timed up and go test (TUG) [Срок оценки: Baseline and 3 months after surgery]
• 10 meter walk test (10MWT) [Срок оценки: Baseline and 3 months after surgery]
• Berg balance scale (BBS) [Срок оценки: Baseline and 3 months after surgery]

Вторичные конечные точки (9)

• Isokinetic peak torque of knee flexion at 60°/s [Срок оценки: Baseline and 3 months after surgery]
• Isokinetic peak torque of knee flexion at 150°/s [Срок оценки: Baseline and 3 months after surgery]
• Isokinetic peak torque of knee extension at 60°/s [Срок оценки: Baseline and 3 months after surgery]
• Isokinetic peak torque of knee extension at 150°/s [Срок оценки: Baseline and 3 months after surgery]
• Isokinetic total work of knee flexion at 60°/s [Срок оценки: Baseline and 3 months after surgery]
• Isokinetic total work of knee flexion at 150°/s [Срок оценки: Baseline and 3 months after surgery]
• Isokinetic total work of knee extension at 60°/s [Срок оценки: Baseline and 3 months after surgery]
• Isokinetic total work of knee extension at 150°/s [Срок оценки: Baseline and 3 months after surgery]
• Whole body phase angle at 50kHz [Срок оценки: Baseline and 3 months after surgery]

Критерии участия

Критерии включения

• Individuals aged 55 and over (based on the age on their national ID at the time of consent)
• Individuals diagnosed with knee OA based on medical history, physical examination, and radiographic assessments.
• Individuals who plan to perform total knee arthroplasty

Критерии исключения

• Individuals with gait disturbance due to neurologic disorders such as Parkinson disease, stroke and dementia
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

South Korea · 1 центр

• Yongin Severance Hospital — Yongin-si

Публикации

• 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. PMID 31436391
• 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. PMID 37344079
• 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. PMID 29748659
• 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. PMID 36759377
• 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. PMID 23462496
• 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. PMID 19844772
• 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. PMID 35358318
• 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. PMID 31421025

Идентификаторы

NCT: NCT06701474 · 9-2024-0150

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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