NIPH Clinical Trials Search

How Insert Design Affects Leg Muscle Activity After Total Knee Arthroplasty

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Knee osteoarthritis
Date of first enrollment	02/05/2025
Target sample size	5
Countries of recruitment
Study type	Interventional
Intervention(s)	The study will target patients who have undergone bilateral TKA and received different inserts (CR-type and MP-type) in each knee. After performing a resting MRI, the patients will engage in stair ascent and descent exercises for 60 repetitions, followed by an immediate post-exercise MRI.

Outcome(s)

Primary Outcome	Muscle activity will be evaluated using T2 relaxation times obtained from MRI T2 mapping. Regions of interest (ROIs) will be defined for each thigh muscle, and changes in T2 relaxation times between resting and post-exercise MRI will be measured.
Secondary Outcome	Quadriceps muscle strength will be measured to evaluate its association with muscle activity.

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Both
Include criteria	1) Patients who have undergone bilateral total knee arthroplasty (TKA) for osteoarthritis more than one year ago 2) Patients who received a cruciate-retaining (CR) insert in one knee and a medial-pivot (MP) insert in the other knee 3) Patients who are eligible for MRI examination 4) Outpatients 5) Patients who have provided written informed consent to participate in this study
Exclude criteria	1) Patients with inflammatory diseases such as rheumatoid arthritis 2) Patients with secondary knee osteoarthritis due to ligament injury or other causes 3) Patients who are unable to perform stair ascent and descent 4) Patients with missing data on postoperative clinical outcomes or imaging findings