Swiss-wide multicentre evaluation and prediction of core outcomes in arthroscopic rotator cuff repair: protocol for the ARCR_Pred cohort study

Laurent Audigé, Heiner C C Bucher, Soheila Aghlmandi, Thomas Stojanov, David Schwappach, Sabina Hunziker, Christian Candrian, Gregory Cunningham, Holger Durchholz, Karim Eid, Matthias Flury, Bernhard Jost, Alexandre Lädermann, Beat Kaspar Moor, Philipp Moroder, Claudio Rosso, Michael Schär, Markus Scheibel, Christophe Spormann, Thomas Suter, Karl Wieser, Matthias Zumstein, ARCR_Pred Study Group, Andreas M Müller, Jannine Buchschacher, Lena Fankhauser, Corinne Eicher, Gernot Willscheid, Doruk Akgün, Kathi Thiele, Marvin Minkus, Victor Danzinger, Katrin Karpinski, Sebastian Mueller, 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, Hans-Kaspar Schwyzer, Fabrizio Moro, Michael Glanzmann, Barbara Wirth, Christian Jung, Florian Freislederer, Manuela Nötzli, Frederik Bellmann, Franz Anne, Jörg Oswald, Alex Marzel, 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, Florian Grubhofer, Sabrina Catanzaro, Sabine Wyss, Reto Sutter, Mohy Taha, Cornelia Baum, Ilona Ahlborn, Simone Hatz, Giorgio Tamborrini-Schütz, Christian Appenzeller-Herzog, Laurent Audigé, Heiner C C Bucher, Soheila Aghlmandi, Thomas Stojanov, David Schwappach, Sabina Hunziker, Christian Candrian, Gregory Cunningham, Holger Durchholz, Karim Eid, Matthias Flury, Bernhard Jost, Alexandre Lädermann, Beat Kaspar Moor, Philipp Moroder, Claudio Rosso, Michael Schär, Markus Scheibel, Christophe Spormann, Thomas Suter, Karl Wieser, Matthias Zumstein, ARCR_Pred Study Group, Andreas M Müller, Jannine Buchschacher, Lena Fankhauser, Corinne Eicher, Gernot Willscheid, Doruk Akgün, Kathi Thiele, Marvin Minkus, Victor Danzinger, Katrin Karpinski, Sebastian Mueller, 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, Hans-Kaspar Schwyzer, Fabrizio Moro, Michael Glanzmann, Barbara Wirth, Christian Jung, Florian Freislederer, Manuela Nötzli, Frederik Bellmann, Franz Anne, Jörg Oswald, Alex Marzel, 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, Florian Grubhofer, Sabrina Catanzaro, Sabine Wyss, Reto Sutter, Mohy Taha, Cornelia Baum, Ilona Ahlborn, Simone Hatz, Giorgio Tamborrini-Schütz, Christian Appenzeller-Herzog

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).

Keywords: musculoskeletal disorders; orthopaedic & trauma surgery; shoulder.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1
Figure 1
Flow chart of study procedures. AE survey: surgeon and patient survey regarding AE severity (sev). Motion: shoulder range of motion. Rehab: recall on postoperative rehabilitation. *If MRI not possible. AE, adverse event; CES, core event set; CS, Constant Score; CT, arthro-CT; DE, German; EN, English; EQ-5D-5L, European Quality of Life 5 Dimensions 5 Level questionnaire; FR, French; FU, follow-up; IT, Italian; NRS, Numeric Rating Scale; OSS, Oxford Shoulder Score; RC, rotator cuff; SSV, subjective shoulder value.

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