Safety and feasibility evaluation of tourniquets for total knee replacement (SAFE-TKR): study protocol.

ABSTRACT:

Introduction

This study is designed to determine whether a full randomised controlled trial (RCT) examining the clinical effectiveness and safety of total knee replacement surgery with or without a tourniquet is warranted and feasible.

Method and analysis

Single centre, patient-blinded and assessor-blinded RCT. A computer-generated randomisation service will allocate 50 participants into one of two trial treatments, surgery with or without a tourniquet. The primary objective is to estimate recruitment, crossovers and follow-up of patients. All patients will have an MRI scan of their brain preoperatively and day 1 or 2 postoperatively to identify ischaemic cerebral emboli (primary clinical outcome). Oxford Cognitive Screen, Montreal Cognitive Assessment and Mini-Mental State

SUBMITTER: Wall PD 

PROVIDER: S-EPMC5900804 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature