Trials / Recruiting
RecruitingNCT06701474
Comparison of Functional Recovery After Total Knee Arthroplasty Between Low Phase Angle and High Phase Angle Group
Association Between Phase Angle and Functional Recovery After Total Knee Arthroplasty
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- Yonsei University · Academic / Other
- Sex
- All
- Age
- 55 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2024-09-13
- Primary completion
- 2025-09-23
- Completion
- 2025-09-23
- First posted
- 2024-11-22
- Last updated
- 2025-02-07
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT06701474. Inclusion in this directory is not an endorsement.