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Surgical safety and effectiveness in orthopedics: Swiss-wide multicenter evaluation and prediction of core outcomes in arthroscopic rotator cuff reconstruction

Research Project
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01.02.2020
 - 30.09.2024

Valid clinical outcome data are essential to assess the safety and effectiveness of surgical interventions, to perform benchmarking activities and to foster a well-founded decision-making process in orthopedics. In the fields of arthroscopic rotator cuff repair (ARCR), the number of ARCR procedures and published studies has grown exponentially in the last decade, yet reporting standards differ dramatically. This is particularly notable concerning adverse events (AE) as in most fields of orthopedic surgery. In addition, published prognostic studies were methodologically poor, based on small datasets and explored only limited numbers of potentially influencing factors.A prospective multicenter clinical study of a large ARCR patient cohort will be implemented on a representative group of 17 Swiss and one German specialized clinics allowing for the evaluation of targeted core safety, clinical and patient-reported outcomes. The primary objective will be the development of prediction models for individual patients. The primary outcomes will be the patient-reported subjective assessment of shoulder function (Oxford Shoulder Score) and the occurrence of shoulder stiffness up to 12 months after primary repair surgery. Multiple prognostic factors will be investigated including patient baseline demographics, psychological, socioeconomic and clinical factors, rotator cuff integrity and concomitant local findings, operative and postoperative management factors. The secondary objectives are to evaluate the content and applicability of a consensus core set of AEs (CES) considering the patient's perspective, validate a severity classification for AEs, and quantify clinically-relevant ARCR outcomes up to 24 months postoperatively. Prognostic models will also be extended to all secondary outcomes.A sample size of 970 ARCR patients will be included; baseline patient demographics, history, shoulder status, magnetic resonance imaging based diagnosis and operative details will be recorded. Patient outcomes will be documented 6, 12 and 24 months after surgery. Clinical examinations at 6 and 12 months will include shoulder range of motion and strength (Constant Score), as well as the documentation of AEs. Tendon repair integrity status will be assessed by ultrasound examination at 12 months. Patient-reported outcome questionnaires at all follow-up time points will determine functional scores (Subjective Shoulder Value, Oxford Shoulder Score), anxiety and depression scores, working status, quality of life (EuroQol EQ-5D-5L), and AEs. All AEs will be documented according to the consensus CES and classified by their degree of severity; patients will rate the perceived severity and disturbance of experienced AEs. We will use the web-based REDCap data capture system for data management. Intensive central monitoring will be performed and investigator meetings will be coordinated during the study. The adapted AE severity classification will be validated. All data will be tabulated and prediction models will be developed using internationally supported methodology.This project will initiate the development of personalized risk predictions to support the surgical decision process in ARCR. The consensus CES may become an international reference for the reporting of complications in clinical studies and registers. The proposed study will foster the condition towards the development of a Swiss national ARCR register. Such a study and registry is an important step to increasing transparency in orthopedic surgery as requested by the federal strategy in healthcare "Health 2020". Methodological insights gained from this work will be easily transferable to similar initiatives in orthopedics.

Funding

Surgical safety and effectiveness in orthopedics: Swiss-wide multicenter evaluation and prediction of core outcomes in arthroscopic rotator cuff reconstruction

SNF Projekt (GrantsTool), 09.2019-08.2023 (48)
PI : Audigé, Laurent.
CI : Müller, Marc Andreas.

Publications

Audigé, Laurent et al. (2026) ‘Comparison of articular-sided, bursal-sided, and intratendinous partial rotator cuff tears: outcomes of surgical repair from a multicenter cohort study’, Journal of Orthopaedic Surgery and Research, 21. Available at: https://doi.org/10.1186/s13018-025-06643-w.

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Pichler, Lieselotte et al. (2026) ‘Prognostic Factors for Repair Integrity After Arthroscopic Rotator Cuff Repair: A Systematic Review and Meta-analysis’, Orthopaedic Journal of Sports Medicine. 08.07.2026, 14(7). Available at: https://doi.org/10.1177/23259671261455856.

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Matter, Madlaina et al. (2026) ‘Return to sport after arthroscopic rotator cuff repair: epidemiology and prognostic factors in a Swiss multicentre cohort’, British Journal of Sports Medicine, 60, pp. 116–124. Available at: https://doi.org/10.1136/bjsports-2025-110358.

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Stojanov, Thomas et al. (2025) ‘Update of a prediction model for postoperative shoulder stiffness after arthroscopic rotator cuff repair’, Communications Medicine. 02.10.2025, 5(1), pp. 1–8. Available at: https://doi.org/10.1038/s43856-025-01125-w.

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Grezda, Kushtrim et al. (2025) ‘Safety of arthroscopic rotator cuff repair: Using a core event set for clinician and patient assessment of risks in a multicenter cohort study’, BMJ Surgery, Interventions, and Health Technologies. 25.09.2025, 7(1). Available at: https://doi.org/10.1136/bmjsit-2025-000400.

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Felbar, Daniel et al. (2025) ‘Validity Assessment of the Swiss Orthopaedics Minimal Data Set compared to the subjective shoulder value for rotator cuff repair in relation to Constant score’, The Hive - Musculoskeletal Journal, 1(1), pp. 1–6. Available at: https://doi.org/10.70885/hmsj.2025.05.002.

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Feltri, Pietro et al. (2025) ‘Rotator cuff repair: Sleep disturbance significantly improves after arthroscopic tendon repair’, Knee Surgery, Sports Traumatology, Arthroscopy. 27.08.2024, 33(4), pp. 1459–1471. Available at: https://doi.org/10.1002/ksa.12420.

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Selman, Farah et al. (2025) ‘The impact of biceps tenotomy/tenodesis on Popeye sign incidence and functional outcome’, JSES International. 23.11.2024, 9(2), pp. 373–379. Available at: https://doi.org/10.1016/j.jseint.2024.10.015.

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Stojanov, Thomas et al. (2025) ‘Baseline characteristics and 2-year functional outcome data of patients undergoing an arthroscopic rotator cuff repair in Switzerland, results of the ARCR-Pred study’, Plos One, 20. Available at: https://doi.org/10.1371/journal.pone.0316712.

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Brune, Daniela et al. (2024) ‘Understanding preoperative health-related quality of life in rotator cuff tear patients: role of patients’ characteristics’, BMC Musculoskeletal Disorders, 25. Available at: https://doi.org/10.1186/s12891-024-08099-1.

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Baum, Cornelia et al. (2024) ‘Functional and Radiologic Outcomes of Degenerative Versus Traumatic Full-Thickness Rotator Cuff Tears Involving the Supraspinatus Tendon’, American Journal of Sports Medicine, 52(2), pp. 441–450. Available at: https://doi.org/10.1177/03635465231219253.

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Stojanov, T. et al. (2023) ‘Development and internal validation of a model predicting patient-reported shoulder function after arthroscopic rotator cuff repair in a Swiss setting’, Diagnostic and Prognostic Research, 7(1). Available at: https://doi.org/10.1186/s41512-023-00156-y.

URLs
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Stojanov, Thomas et al. (2023) ‘Prognostic factors for improvement of shoulder function after arthroscopic rotator cuff repair: a systematic review’, JSES international, 7(1), pp. 50–57. Available at: https://doi.org/10.1016/j.jseint.2022.09.003.

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Stojanov, Thomas et al. (2022) ‘Prognostic factors for the occurrence of post-operative shoulder stiffness after arthroscopic rotator cuff repair: a systematic review’, BMC Musculoskeletal Disorders, 23(1), p. 99. Available at: https://doi.org/10.1186/s12891-022-05030-4.

URLs
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Audigé, Laurent et al. (2021) ‘Swiss-wide multicentre evaluation and prediction of core outcomes in arthroscopic rotator cuff repair: Protocol for the ARCR_Pred cohort study’, BMJ Open, 11(4). Available at: https://doi.org/10.1136/bmjopen-2020-045702.

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Members (5)

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Laurent Audigé

Principal Investigator
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Marc Andreas Müller

Co-Investigator
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Thomas Stojanov

PhD Student / Post-Doc
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Soheila Aghlmandi

Statistical advisor
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Eleonora Croci

Post-Doc