Constraint choice in revision knee arthroplasty: study protocol of a randomised controlled trial assessing the effect of level of constraint on postoperative outcome

INTRODUCTION The proper management of total knee arthroplasty (TKA) in patients with severe deformities regarding the preferable prosthetic design and the required amount of constraint is a controversial subject. In the absence of any high-level clinical evidence, we designed a randomised clinical trial to investigate if rotating hinged (RTH) and constrained condylar knee (CCK) designs yield similar outcomes. METHODS AND ANALYSIS This study is a multicentre, randomised clinical trial including two groups of 85 patients. Patients will be randomised to a CCK knee design group or an RTH knee design group. Patients will be followed for 2 years. The study will be designed as an equivalence trial. The primary study outcome will be the postoperative functional outcome as measured by the self-administered Knee Injury and Osteoarthritis Outcome Score. Secondary outcomes will be postoperative joint awareness during various activities of daily living as measured by the Forgotten Joint Score-12, the Knee Society Score, along with the incidence and location of radiolucent lines using the Knee Society TKA radiographic evaluation system. ETHICS AND DISSEMINATION This study is approved by the ethics committee of the Landesärztekammer Brandenburg ((S 10(a)/2013) from 27.08.2013, amended on 25.04.2016) and will be conducted according to the principles of the World Medical Association Declaration of Helsinki and the ISO14155:2011. TRIAL REGISTRATION NUMBER DRKS00010539.