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IntroductionThere is a lack of harmonising measures for clinical trials on total joint replacement (TJR) that would allow for results from TJR studies to be compared or pooled. The Outcome Measures in Rheumatology (OMERACT) TJR core domain set is already endorsed among patients and physicians in the USA and Australia. Physiotherapists use different types of measurements compared to orthopaedic surgeons while both make substantial contributions to research in the field of TJR. To achieve consensus on core measurements sets, patients, physiotherapists and orthopaedic surgeons need to achieve consensus on the core domains for TJR trials.Methods and analysisFor this multistage study, first, the OMERACT TJR core domain set survey will be translated to German and validated according to WHO guidelines. Next, the TJR core domain set will be considered for endorsement in different German stakeholder groups including patients, physiotherapists and orthopaedic surgeons.Ethics and disseminationEthical approval for this protocol was given by the ethics committee of the Brandenburg University of Technology Cottbus—Senftenberg (BTU—CS, EK 2019—2). This article is based on the protocol version 2.5 from 6 May 2020. Anonymous data will be presented only. We will publish the results in peer-reviewed publications and at international conferences.Trial registration numberGerman Clinical Trials Registry (DRKS00016015).

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 Landesarztekammer 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.