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

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e045702
Author(s):  
Laurent Audigé ◽  
Heiner C C Bucher ◽  
Soheila Aghlmandi ◽  
Thomas Stojanov ◽  
David Schwappach ◽  
...  

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).

2015 ◽  
Vol 40 (2) ◽  
pp. 323-329 ◽  
Author(s):  
Arjen Kolk ◽  
Nienke Wolterbeek ◽  
Kiem Gie Auw Yang ◽  
Jacco A. C. Zijl ◽  
Ronald N. Wessel

2019 ◽  
Vol 28 (6) ◽  
pp. S124-S130 ◽  
Author(s):  
Philip Zakko ◽  
Bastian Scheiderer ◽  
Knut Beitzel ◽  
Monica Shoji ◽  
Ariel Williams ◽  
...  

2011 ◽  
Vol 40 (3) ◽  
pp. 631-639 ◽  
Author(s):  
Seok Won Chung ◽  
Ji Soon Park ◽  
Sae Hoon Kim ◽  
Seung Han Shin ◽  
Joo Han Oh

2020 ◽  
Vol 48 (6) ◽  
pp. 1471-1475
Author(s):  
Matthew J. Gotlin ◽  
Matthew T. Kingery ◽  
Samuel L. Baron ◽  
Joseph McCafferty ◽  
Laith M. Jazrawi ◽  
...  

Background: The gold-standard method for collecting patient-reported outcomes (PROs) is the prospective assessment of preoperative to postoperative change. However, this method is not always feasible because of unforeseen cases or emergencies, logistical and infrastructure barriers, and cost issues. In such cases, a retrospective approach serves as a potential alternative, but there are conflicting conclusions regarding the reliability of the recalled preoperative PROs after orthopaedic procedures. Purpose: To assess the agreement between prospectively and retrospectively collected PROs for a common, low-risk procedure. Study Design: Cohort study (Diagnosis); Level of evidence, 3. Methods: Patients who underwent arthroscopic rotator cuff repair between May 2012 and September 2017 at the study institution were identified. All of the patients completed the American Shoulder and Elbow Surgeons (ASES) Standard Shoulder Assessment Form preoperatively at their preassessment appointment. Patients were then contacted in the postoperative period and asked to recall their preoperative condition while completing another ASES form. Results: A total of 84 patients completed the telephone survey and were included in this analysis (mean age, 57.40 ± 9.96 years). The mean duration of time from onset of shoulder symptoms to surgery was 9.13 ± 9.08 months. The mean duration of time between surgery and recall ASES administration was 39.12 ± 17.37 months. The mean recall ASES score was significantly lower than the preoperative ASES score (30.69 ± 16.93 vs 51.42 ± 19.14; P < .001). There was poor test-retest reliability between preoperative ASES and recall ASES (intraclass correlation coefficient, 0.292; 95% CI, –0.07, 0.57; P = .068). Greater age at the time of recall, a shorter symptomatic period before surgery, and less severe preoperative shoulder dysfunction were associated with a greater difference between preoperative ASES and recall ASES. Conclusion: Retrospectively reported PROs are subject to significant recall bias. Recalled PROs were almost always lower than their prospectively recorded counterparts. Recalled PROs are more likely to be accurate when reported by younger patients, those with a longer duration of symptoms, and those with more severe preoperative conditions.


2018 ◽  
Vol 6 (7_suppl4) ◽  
pp. 2325967118S0008 ◽  
Author(s):  
Brian Robert Waterman ◽  
Jonathan Newgren ◽  
Anirudh K. Gowd ◽  
Brandon C. Cabarcas ◽  
Bernard R. Bach ◽  
...  

Objectives: To evaluate long-term clinical outcomes after arthroscopic rotator cuff repair with and without acromioplasty. Methods: Between 2007-2011, prospectively-enrolled patients undergoing arthroscopic repair for full-thickness rotator cuff tears were previously randomized into either acromioplasty or non-acromioplasty groups. Patients with death, advanced neurologic conditions, or subsequent shoulder arthroplasty were excluded. Baseline and long-term follow-up questionnaires, including the American Shoulder and Elbow Surgeons (ASES), Simple Shoulder Test (SST), University of California-Los Angeles (UCLA), Visual Analog Scale (VAS) for pain, and Constant scores were obtained. Rates of revision rotator cuff surgery, or secondary reoperation were recorded. Averages with standard deviation (SD) were calculated, and t-tests were utilized to compare outcomes of interest between cohorts. Results: After exclusion of 5 additional patients from the short-term follow-up study, 66 of 90 patients (73.3%) were available at 92.4 months (±10.5). Comparison of baseline demographics and intraoperative information revealed no significant differences, including age, gender, workers compensation, acute mechanism of injury, tear size, degree of retraction, and surgical technique (e.g. single- vs. double-row). At final follow-up, there were no statistically significant differences according to ASES (p=0.33), VAS pain (p=0.79), Constant (p=0.17), SST (p=0.05), UCLA (p=0.19), and SF-12 (p=0.79) in patients with and without acromioplasty (Figure 1). One patient with acromioplasty (2.9%) and two patients without acromioplasty (6.3%) sustained atraumatic recurrent rotator cuff tear with secondary repair (p=0.99). Conclusion: Combined acromioplasty and rotator cuff repair offer no significant long-term benefits in patient-reported outcomes or secondary surgery when compared to arthroscopic rotator cuff repair alone. [Figure: see text]


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