A comparative study of the efficacy of different doses of platelet-rich plasma in the treatment of Degree I and Degree II knee meniscus injury in young adults: Study protocol for a prospective, single-center, three-blind, randomized controlled trial

Abstract

Abstract Background: Grade I and II knee meniscus injuries in young people account for a relatively large proportion of sports injuries. If not cured in time, it may seriously affect the quality of life and even cause disability.Studies have shown that platelet-rich plasma (PRP) is effective in the treatment of knee meniscus injury, but the optimal therapeutic dose of PRP has not been regulated and clarified in current relevant guidelines or expert consensus.This study intends to use a randomized controlled trial to compare and analyze the efficacy and safety of 2ml, 5ml and 8ml PRP in the treatment of meniscus injury of knee joint, so as to provide evidence-based medical evidence for improving the clinical guidelines for the treatment of meniscus injury with PRP. Methods/design: This study is a one-year prospective single-center triple-blind randomized controlled trial. Patients who meet the inclusion criteria are randomly divided into the experimental group and the control group. The experimental group is set as the PRP treatment group, and the control group is set as the placebo group. The treatment of all patients will last for 5 weeks and follow-up for 6 months.The experimental group and the control group plan to evaluate Lysholm knee score, MRI (including T2mapping technology) and other main observation indicators.And visual analog scale (Visual analogue scale, VAS), quality of life score(36-item Short Form Health Survey, SF-36), muscle Bone ultrasound, infrared thermal imaging,incidence of adverse reactions and other secondary observation indicators are used to compare the curative effects.All these results will be analyzed at the end of the trial Analysis. Discussion: There is no uniform standard for the dose of PRP in the treatment of meniscus injury, and there is no literature report on whether there are differences in efficacy and safety among several commonly used doses in clinical practice. This study explores the clinical appropriate dose of PRP in the treatment of meniscus injury of knee joint of young people in degree I and II,which provides a scientific basis for the optimization of the treatment of meniscus injury, and provides evidence-based medical evidence for the revision and improvement of PRP treatment guidelines for meniscus injury. Trial Registration: China Clinical Trial Registration: ChiCTR2200057591, November 14,2022 Experimental Ethics: 2022EC1-008