変形性膝関節症におけるPRPの有効性 (PRP)

アクティブコンパレータ：T-LAB / NEXT PRP SYRINGE

In the first group (PRP1 group; non-anticoagulant pure PRP), prepared with Next PRP Syringe in 3 sessions will be applied.

他の：Intra-articular T-LAB / Next PRP Syringe

Anticoagulant-free pure PRP will be prepared using T-LAB / Next PRP Syringe. 4 ml of PRP will be injected intra-articularly three times at 2-week intervals. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, and short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.

アクティブコンパレータ：T-LAB / PRP KIT

In the second group (PRP2 group; amber PRP) prepared with T-LAB / PRP KIT in 3 sessions will be applied.

他の：Intra-articular T-LAB / PRP KIT injection

PRP containing anticoagulant will be prepared using T-LAB / PRP KIT. 4 ml of PRP will be injected intra-articularly three times at 2-week intervals. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, and short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.

偽コンパレータ：SALINE

In the third group (saline group), prepared with SALINE in 3 sessions will be applied.

他の：Intra-articular SALINE injection

Similar to the PRP protocol, 4 mL of 0.9% sodium chloride will be injected intra-articularly. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, and short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.

1 か月、3 か月、および 6 か月のベースライン活動疼痛スコアからの変化

Visual Analogue Scale-Activity の痛み (0 ～ 10 ポイント)。 スコアが高いほど、結果が悪いことを意味します

Change from baseline activity pain score at 1-months, 3-months and 6-months

Visual Analogue Scale-Rest pain (0-10 point). Higher scores mean a worse outcome

Change from baseline pain, stiffness and physical function at 1-months, 3-months and 6-months

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measures knee pain, stiffness, and physical function. The scores for each subscale are summed, with possible ranges of 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function. The sum of the scores for the three subscales gives a total WOMAC score. High scores are associated with more pain, stiffness, and poor function, while low scores indicate well-being.

Change from baseline quality of life and global assessment at 1-months, 3-months and 6-months

Quality of life and global assessment evaluate using a numeric rating scale (NRS) ranging from 0 to 10. Higher scores mean a worse outcome..

Change from baseline functional balance at 3-months and 6-months

The Timed Up and Go test requires the person to stand up from a standard chair in which they are sitting, walk 3 meters at a comfortable speed to the marked place on the floor, turn around, walk backwards to the starting point, and return to the sitting position in the chair. The time taken for the person to complete the test is measured in seconds. The timing of the test is related to the function.

Change from baseline femoral cartilage thickness measurement by ultrasound at 6 months

Distal femoral cartilage thickness will be evaluated by the same clinician. We will use the MyLab60 model ultrasonography device and a high-resolution 7-12 MHz linear probe available in our clinic. During measurement, patients will be prone with knees in full flexion and ankles in neutral. The probe will be placed axially in the suprapatellar area at the outer edge of the patella. The distal femoral cartilage will be imaged anechogenically between the hyperechogenic bony cortex and suprapatellar fat. Next, we will measure the distance between the thin hyperechoic line of the synovial cavity on the stratified face and the hyperechoic sharp line on the bony face of the cartilage. This will be recorded as the thickness of the cartilage. For each intervention knee, cartilage thickness will be determined by recording three measurements from the midpoint: lateral condyle, intercondylar area, and medial condyle.