The Effect of Tourniquet Application on the Morphology and Function of Quadriceps in Patients Undergoing Total Knee Arthroplasty: A Study Protocol for a Single Blind Randomized Controlled Trial

Abstract

Background:Tourniquet is currently widely used in total knee arthroplasty to reduce intraoperative blood loss. Academic view of tourniquet application in TKA is now in dispute. Some scholars argue that tourniquet may cause quadriceps injury and bring extra side effects so they oppose the application of tourniquet. Others find that tourniquet application has no significant adverse impact on TKA patients. Regarding its advantages in reducing intraoperative blood loss, they advocate regular application of tourniquet in TKA. Quadriceps injury is considered the main cause of tourniquet side effects. There are now many high-quality trials about tourniquet application in TKA but few of them concentrate on quadriceps morphology and function.Methods:A prospective, single blind, randomized controlled trail will be adopted. The target sample is 130. Patients who meet the eligibility criteria will be randomly allocated to tourniquet group and non-tourniquet group. Primary outcomes are thickness, stiffness and function of quadriceps, which will be evaluated by ultrasound and rehabilitation tests. Secondary outcomes consist of circumference of thigh, VAS score, opioid consumption, knee function score, postoperative satisfaction score, operation time, intraoperative blood loss, perioperative blood loss, blood transfusion rate, D-Dimer, C-reactive protein, and complications. Discussion:This proposed study will contribute to improve evidence of tourniquet application in total knee arthroplasty. This will be a high-quality single blind randomized controlled trial with sufficient sample size and strict study design. It will investigate the effects of tourniquet application especially on the morphology and function of quadriceps in patients undergoing total knee arthroplasty and offer advice for tourniquet application in clinical practice.Trial registration:Chinese clinical trial registry, ChiCTR2000035097. Registered 31 July 2020, http://www.chictr.org.cn/showproj.aspx?proj=57093