Clinical trial NCT06701474: Comparison of Functional Recovery After Total Knee Arthroplasty Between Low Phase Angle and High Phase Angle Group
Official title: Association Between Phase Angle and Functional Recovery After Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Knee Osteoarthritis
Keywords: total knee arthroplasty
phase angle
sarcopenia
bioelectrical impedance
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 200
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Single general hospital

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Timed up and go test (TUG)
timeFrame: Baseline and 3 months after surgery
measure: 10 meter walk test (10MWT)
timeFrame: Baseline and 3 months after surgery
measure: Berg balance scale (BBS)
timeFrame: Baseline and 3 months after surgery
Secondary outcomes:
measure: Isokinetic peak torque of knee flexion at 60°/s
timeFrame: Baseline and 3 months after surgery
measure: Isokinetic peak torque of knee flexion at 150°/s
timeFrame: Baseline and 3 months after surgery
measure: Isokinetic peak torque of knee extension at 60°/s
timeFrame: Baseline and 3 months after surgery
measure: Isokinetic peak torque of knee extension at 150°/s
timeFrame: Baseline and 3 months after surgery
measure: Isokinetic total work of knee flexion at 60°/s
timeFrame: Baseline and 3 months after surgery
measure: Isokinetic total work of knee flexion at 150°/s
timeFrame: Baseline and 3 months after surgery
measure: Isokinetic total work of knee extension at 60°/s
timeFrame: Baseline and 3 months after surgery
measure: Isokinetic total work of knee extension at 150°/s
timeFrame: Baseline and 3 months after surgery
measure: Whole body phase angle at 50kHz
timeFrame: Baseline and 3 months after surgery
Other outcomes:
Locations:
city: Yongin-si
country: Korea, Republic of
facility: Yongin Severance Hospital
state: Gyeonggi-do
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.