1. Swiss-wide multicentre evaluation and prediction of core outcomes in arthroscopic rotator cuff repair: protocol for the ARCR_Pred cohort study
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Alexandre Lädermann, Heiner C C Bucher, Corinne Eicher, Sabina Hunziker, Christian Appenzeller-Herzog, Florian Grubhofer, Soheila Aghlmandi, Alex Marzel, Hans-Kaspar Schwyzer, Fabrizio Moro, Matthias Flury, Barbara Wirth, Markus Scheibel, Laurent Audigé, Philipp Moroder, Sebastian Mueller, Thomas Stojanov, David Schwappach, Christian Candrian, Gregory Cunningham, Holger Durchholz, Karim Eid, Bernhard Jost, Beat Kaspar Moor, Claudio Rosso, Michael Schär, Christophe Spormann, Thomas Suter, Karl Wieser, Matthias Zumstein, Andreas M Müller, Jannine Buchschacher, Lena Fankhauser, Gernot Willscheid, Doruk Akgün, Kathi Thiele, Marvin Minkus, Victor Danzinger, Katrin Karpinski, Claudia Haag-Schumacher, Viviane Steffen, Sarah Fournier, Deborah Marietan, Sebastien Pawlak, Britta Hansen, Ferdinand Lovrek, Marco Zanetti, Nadja Mamisch, Christian Steiner, Georg Ahlbäumer, Jakob Bräm, Jens Fischer, Alexander Delvendahl, Patricia Simao, Abed Khourani, Anne-Sophie Foucault, Frank Kolo, Adrian Schenk, Johannes Weihs, Remy Flückiger, Philipp Scacchi, Paolo Lombardo, Larissa Hübscher, Ralph Berther, Christine Ehrmann, Raffaela Nobs, Richard Niehaus, Nisha Grünberger, Philipp Kriechling, Susanne Bensler, Michael Glanzmann, Florian Freislederer, Manuela Nötzli, Frederik Bellmann, Franz Anne, Jörg Oswald, Cécile Grobet, Marije de Jong, Martina Wehrli, Jan Schätz, Francesco Marbach, Marco Delcogliano, Davide Previtali, Florian Schönweger, Elena Porro, Gabriela Induni-Lang, Giuseppe Filardo, Filippo Del Grande, Pietro Feltri, Schiavon Guglielmo, Christian Spross, Martin Olach, Michael Badulescu, Vilijam Zdravkovic, Stephanie Lüscher, Jörg Scheler, Lena Öhrström, Annabel Hayoz, Frederick Schuster, Julia Müller-Lebschi, Christian Gerber, Samy Bouaicha, Paul Borbas, Anita Hasler, Sabrina Catanzaro, Sabine Wyss, Reto Sutter, Mohy Taha, Cornelia Baum, Ilona Ahlborn, Simone Hatz, and Giorgio Tamborrini-Schütz
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Medicine - Abstract
Introduction In the field of arthroscopic rotator cuff repair (ARCR), reporting standards of published studies differ dramatically, notably concerning adverse events (AEs). In addition, prognostic studies are overall methodologically poor, based on small data sets and explore only limited numbers of influencing factors. We aim to develop prognostic models for individual ARCR patients, primarily for the patient-reported assessment of shoulder function (Oxford Shoulder Score (OSS)) and the occurrence of shoulder stiffness 6 months after surgery. We also aim to evaluate the use of a consensus core event set (CES) for AEs and validate a severity classification for these events, considering the patient’s perspective.Methods and analysis A cohort of 970 primary ARCR patients will be prospectively documented from several Swiss and German orthopaedic clinics up to 24 months postoperatively. Patient clinical examinations at 6 and 12 months will include shoulder range of motion and strength (Constant Score). Tendon repair integrity status will be assessed by ultrasound at 12 months. Patient-reported questionnaires at 6, 12 and 24 months will determine functional scores (subjective shoulder value, OSS), anxiety and depression scores, working status, sports activities, and quality of life (European Quality of Life 5 Dimensions 5 Level questionnaire). AEs will be documented according to a CES. Prognostic models will be developed using an internationally supported regression methodology. Multiple prognostic factors, including patient baseline demographics, psychological, socioeconomic and clinical factors, rotator cuff integrity, concomitant local findings, and (post)operative management factors, will be investigated.Ethics and dissemination This project contributes to the development of personalised risk predictions for supporting the surgical decision process in ARCR. The consensus CES may become an international reference for the reporting of complications in clinical studies and registries. Ethical approval was obtained on 1 April 2020 from the lead ethics committee (EKNZ, Basel, Switzerland; ID: 2019-02076). All participants will provide informed written consent before enrolment in the study.Trial registration number NCT04321005.Protocol version Version 2 (13 December 2019).
- Published
- 2021
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