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

Abstract

IntroductionIn 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 analysisA 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 disseminationThis 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 numberNCT04321005.Protocol versionVersion 2 (13 December 2019).

Prognostic factors for improvement of shoulder function after arthroscopic rotator cuff repair: a systematic review

“…The results of the present review are the initial step toward developing prediction models in ARCR outcomes as part of our ARCR_Pred cohort study. 2 …”

“…In the field of arthroscopic rotator cuff repair (ARCR), clinicians base their recommendation for surgery on multiple factors including the patient's potential for shoulder function improvement. A Swiss multicenter ARCR cohort was implemented to develop and validate clinical prediction models for key postoperative outcomes including shoulder function improvement, 2 which ultimately support an evidence-based decision-making process. However, the development and validation of such clinical prediction models require a cautious research strategy, 29 that begins with the identification of factors specifying the clinical prediction models and relies on both expert assessment and literature review.…”

Development and validation of a model predicting patient-reported shoulder function after arthroscopic rotator cuff repair in a Swiss setting

“…This modeled evidence might then be discussed with patients during clinical examinations to forecast their possibilities of improvements after surgery based on informed consideration of a set of preestablished factors. The limitations encountered in this study can be addressed by stronger national support in the development of clinical registers, which form the basis for value-based health care in orthopedic surgery [15,16].…”

“…The implementation of a local register at a tertiary care clinic in 2013 was the rst step towards better documentation and understanding of health outcome data after ARCR [14]. This register has laid the foundation for carrying out a large national ARCR study initiated in 2020 [15]. Both initiatives are set to predict key health outcome data after ARCR such as that recently established for the occurrence of highly prevalent adverse events, such as post-operative shoulder stiffness [16].…”

Arthroscopic rotator cuff repair: patients with physically demanding work have significantly worse time to return to work, level of employment, and job loss

“…Many clinical studies and meta-analyses have demonstrated that ARCR is efective and safe to successfully treat rotator cuff tears and provide significant post-operative improvement [3][4][5]31]. However, others underline that a signiicant proportion of patients reports shoulder stifness and persistent pain at mid and long-term follow-up both for single and massive tendon repairs [6,24,27], impairing the return to their preoperative shoulder function.…”