Association Between Phase Angle and Functional Recovery After Total Knee Arthroplasty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Yonsei University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Timed up and go test (TUG)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Timed up and go test (TUG)
Time Frame: Baseline and 3 months after surgery
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
10 meter walk test (10MWT)
Time Frame: Baseline and 3 months after surgery
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.
Berg balance scale (BBS)
Time Frame: Baseline and 3 months after surgery
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.
Secondary Outcomes
- 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)
- Isokinetic total work of knee flexion at 150°/s(Baseline and 3 months after surgery)
- Isokinetic total work of knee extension at 60°/s(Baseline and 3 months after surgery)
- Isokinetic total work of knee extension at 150°/s(Baseline and 3 months after surgery)
- Whole body phase angle at 50kHz(Baseline and 3 months after surgery)