Clinical Trials Directory

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.