Swiss-wide multicentre evaluation and prediction of core outcomes in arthroscopic rotator cuff repair: protocol for the ARCR_Pred cohort study. Issue 4 (22nd April 2021)

• Record Type: Journal Article
• Authors: Audigé, Laurent; Bucher, Heiner C C; Aghlmandi, Soheila; Stojanov, Thomas; Schwappach, David; Hunziker, Sabina; Candrian, Christian; Cunningham, Gregory; Durchholz, Holger; Eid, Karim; Flury, Matthias; Jost, Bernhard; Lädermann, Alexandre; Moor, Beat Kaspar; Moroder, Philipp; Rosso, Claudio; Schär, Michael; Scheibel, Markus; Spormann, Christophe; Suter, Thomas; Wieser, Karl; Zumstein, Matthias; Müller, Andreas M
• Other Names: author non-byline.; Buchschacher Jannine author non-byline.; Fankhauser Lena author non-byline.; Eicher Corinne author non-byline.; Willscheid Gernot author non-byline.; Akgün Doruk author non-byline.; Thiele Kathi author non-byline.; Minkus Marvin author non-byline.; Danzinger Victor author non-byline.; Karpinski Katrin author non-byline.; Mueller Sebastian author non-byline.; Haag-Schumacher Claudia author non-byline.; Steffen Viviane author non-byline.; Fournier Sarah author non-byline.; Marietan Deborah author non-byline.; Pawlak Sebastien author non-byline.; Hansen Britta author non-byline.; Lovrek Ferdinand author non-byline.; Zanetti Marco author non-byline.; Mamisch Nadja author non-byline.; Steiner Christian author non-byline.; Ahlbäumer Georg author non-byline.; Bräm Jakob author non-byline.; Fischer Jens author non-byline.; Delvendahl Alexander author non-byline.; Simao Patricia author non-byline.; Khourani Abed author non-byline.; Foucault Anne-Sophie author non-byline.; Kolo Frank author non-byline.; Schenk Adrian author non-byline.; Weihs Johannes author non-byline.; Flückiger Remy author non-byline.; Scacchi Philipp author non-byline.; Lombardo Paolo author non-byline.; Hübscher Larissa author non-byline.; Berther Ralph author non-byline.; Ehrmann Christine author non-byline.; Nobs Raffaela author non-byline.; Niehaus Richard author non-byline.; Grünberger Nisha author non-byline.; Kriechling Philipp author non-byline.; Bensler Susanne author non-byline.; Schwyzer Hans-Kaspar author non-byline.; Moro Fabrizio author non-byline.; Glanzmann Michael author non-byline.; Wirth Barbara author non-byline.; Jung Christian author non-byline.; Freislederer Florian author non-byline.; Nötzli Manuela author non-byline.; Bellmann Frederik author non-byline.; Anne Franz author non-byline.; Oswald Jörg author non-byline.; Marzel Alex author non-byline.; Grobet Cécile author non-byline.; Jong Marije de author non-byline.; Wehrli Martina author non-byline.; Schätz Jan author non-byline.; Marbach Francesco author non-byline.; Delcogliano Marco author non-byline.; Previtali Davide author non-byline.; Schönweger Florian author non-byline.; Porro Elena author non-byline.; Induni-Lang Gabriela author non-byline.; Filardo Giuseppe author non-byline.; Grande Filippo Del author non-byline.; Feltri Pietro author non-byline.; Guglielmo Schiavon author non-byline.; Spross Christian author non-byline.; Olach Martin author non-byline.; Badulescu Michael author non-byline.; Zdravkovic Vilijam author non-byline.; Lüscher Stephanie author non-byline.; Scheler Jörg author non-byline.; Öhrström Lena author non-byline.; Hayoz Annabel author non-byline.; Schuster Frederick author non-byline.; Müller-Lebschi Julia author non-byline.; Gerber Christian author non-byline.; Bouaicha Samy author non-byline.; Borbas Paul author non-byline.; Hasler Anita author non-byline.; Grubhofer Florian author non-byline.; Catanzaro Sabrina author non-byline.; Wyss Sabine author non-byline.; Sutter Reto author non-byline.; Taha Mohy author non-byline.; Baum Cornelia author non-byline.; Ahlborn Ilona author non-byline.; Hatz Simone author non-byline.; Tamborrini-Schütz Giorgio author non-byline.; Appenzeller-Herzog Christian author non-byline.;
• Is Part Of: BMJ open. Volume 11:Issue 4(2021)
• Publication Date: 2021-04-22
• Subjects: orthopaedic & trauma surgery -- musculoskeletal disorders -- shoulder; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2020-045702
• Languages: English
• ISSNs: 2044-6055

Abstract

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).