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

NCT06701474 | Recruiting

• 1 other identifier: 9-2024-0150
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

total knee arthroplasty; phase angle; sarcopenia; bioelectrical impedance

Outcome Measures

Primary Outcomes (3)

• Timed up and go test (TUG)

  Researchers ask patients to rise from a seated position, walk a distance of 3 m, turn around, return to the chair, and sit back. The average time of three trials was recorded as a result

  Baseline and 3 months after surgery

• 10 meter walk test (10MWT)

  Patients are instructed to walk 14 m, including 2 m at both ends for acceleration and deceleration, at their comfortable speed. Gait speed was calculated by dividing the 10m distance by the time taken.

  Baseline and 3 months after surgery

• Berg balance scale (BBS)

  Patients are asked to perform 14 tasks regarding the static and dynamic balance of patients. Each task was rated on a five-point scale from 0 to 4, with a total score of 56.

  Baseline and 3 months after surgery

Secondary Outcomes (9)

• Isokinetic peak torque of knee flexion at 60°/s

  Baseline and 3 months after surgery

• Isokinetic peak torque of knee flexion at 150°/s

  Baseline and 3 months after surgery

• Isokinetic peak torque of knee extension at 60°/s

  Baseline and 3 months after surgery

• Isokinetic peak torque of knee extension at 150°/s

  Baseline and 3 months after surgery

• Isokinetic total work of knee flexion at 60°/s

  Baseline and 3 months after surgery

Study Arms (2)

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

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

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Single general hospital

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yongin Severance Hospital

Yongin-si, Gyeonggi-do, 16995, South Korea

RECRUITING

Related Publications (9)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 37675071 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Sarcopenia

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Na Young Kim, MD, PhD

CONTACT

+82 010 9127 4482; kny8452@yuhs.ac

Young Seok Kim, MD

CONTACT

+82 010 7225 3661; kys3661@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 22, 2024
• Study Start: September 13, 2024
• Primary Completion: September 23, 2025
• Study Completion: September 23, 2025
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)