Exploring Triggers for Delayed Quadriceps Strength Recovery in TKA Patients

JRCT ID: jRCT1032230548

Registered date:10/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Osteoarthritis of the knee, Rheumatoid arthritis
• Date of first enrollment: 17/01/2024
• Target sample size: 80
• Study type: Interventional

Intervention(s)

To evaluate the recovery of quadriceps muscle strength in the mid-to-long term after TKA, follow-up is planned for approximately one year.
1. Ultrasound imaging evaluation: Measurements will be taken twice, on the day before TKA surgery and 2 to 14 days after TKA surgery, and evaluated on the day before discharge from the hospital, at 1 month, 3 months, 6 months, and 12 months.
2. BIODEX: Both the healthy side and the affected side will be measured on the day before TKA surgery. 14 days after TKA surgery, only the healthy side will be measured once. At 1, 3, 6, and 12 months, both the healthy and the affected side will be measured. BIODEX evaluation in the early postoperative period is performed on the healthy side at 14 days postoperatively because of the possibility of inducing wound pain, etc.
3. Body Composition Testing: Body Composition Analyzer In Body720 will be used to evaluate the patient on the day before TKA surgery and 12 months after surgery to diagnose sarcopenia.
4. Joint range of motion measurement: Measured on the day before TKA surgery and twice between 2 and 14 days after TKA surgery, and evaluated at 1 month, 3 months, 6 months, and 12 months after surgery.
5. Grip strength and lower leg circumference measurements: The day before TKA surgery and 12 months after surgery will be evaluated for the diagnosis of sarcopenia.
6. Physical function assessment: Measurements will be taken on the day before TKA surgery and twice within 2-14 days after TKA surgery, and at 1, 3, 6, and 12 months.
7. Knee joint subjective/patient-standing assessment: to be evaluated on the day before TKA surgery and at 1 month and 12 months after surgery.

Outcome(s)

Primary Outcome

1. Evaluation of skeletal muscles and non-contractile tissues around the knee joint (muscle cross-sectional area, muscle thickness, and muscle brightness) using an ultrasound imaging system. Target muscles to be imaged: MAIN rectus femoris, SUB medial vastus medialis, vastus lateralis, and vastus medialis.
2. Evaluation of knee isokinetic/isotonic knee extension and flexion muscle strength (using BIODEX system4).

Secondary Outcome

1. Body Composition Testing; Body Composition Analyzer In Body720 (BioSpace Corporation).
2. Knee joint flexion/extension range of motion evaluation.
3. Grip strength and leg circumference measurement.
4. Physical function assessment; 6m walking speed or 5 times chair stand test, Time Up & Go test (10m walking speed or 30 times chair stand test will be conducted if possible).
5. Subjective and patient-oriented assessment of the knee joint; KOOS (Knee Injury and Osteoarthritis Outcome Score), KSS (Knee Society Scores).

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients 40 years of age or older capable of giving written consent.
2. Patients who have been diagnosed by a physician as having knee joint disease (e.g., knee OA or RA) on x-ray and MRI images, and who are scheduled to undergo TKA.
3. Patients must be observable for the entire study period.

Exclude criteria

1. Patients who are not considered appropriate for the study by the investigator.
2. Patients with bleeding tendency that may cause problems in training, severe complications (respiratory or circulatory diseases) that may interfere with daily life, infectious diseases, etc.
3. Patients with a history of other artificial joint surgery on the same side as the limb in which the TKA was performed.

Related Information

• Primary Sponsor: Kikuchi Naoya