Effectiveness of subacromial injections in rotator cuff lesions: systematic review and meta-analysis protocol.

INTRODUCTION: Subacromial injections are therapeutic options for rotator cuff injuries, with consistent results not well established yet for each drug applied. The objective of this systematic review and meta-analysis is to analyse the effectiveness of the substances used in subacromial injections for the treatment of rotator cuff injuries and shoulder impingement syndrome, considering the functional gain and pain improvement of the shoulder. METHODS AND ANALYSIS: Beginning in November 2022, we will perform a detailed search using the MEDLINE/PubMed, EMBASE, Cochrane Central Register of Controlled Trials and LILACS databases. Relevant grey literature (reference lists, conference abstracts and academic papers) will also be included.Two reviewers will independently screen and extract the information from the literature. Bias and quality of the included studies will be evaluated using the risk of bias assessment tool provided by the Cochrane Collaboration. Statistical analyses will be performed using Review Manager V.5.4 software. ETHICS AND DISSEMINATION: Approval and patient informed consent are not required because we will only include published literature. The results of this research will be disseminated in a peer-reviewed journal and likely through other scientific events. PROSPERO REGISTRATION NUMBER: CRD42020199292.

Total hip arthroplasty versus hemiarthroplasty for displaced femoral neck fracture: a protocol for an overview of systematic reviews.

INTRODUCTION: Hip arthroplasties for the treatment of displaced femoral neck fractures in adults can be total replacement or hemiarthroplasty. Despite the high prevalence of these fractures and large number of studies on the topic, the best choice of arthroplasty to be used remains unclear. The present study aims to overview the results of systematic reviews of randomised controlled trials (RCTs) comparing outcomes between total hip replacement and hemiarthroplasty for displaced femoral neck fractures in adults. METHODS AND ANALYSIS: Four electronic databases (Pubmed, Embase, Cochrane Library and Web of Science) and reference lists from previous reviews will be searched without language limitation. Eligible studies will be systematic reviews of RCT that compare total hip replacement and hemiarthroplasty for treatment of displaced femoral neck fractures in adults. Two reviewers will independently perform study selection, data extraction and quality assessment. Disagreements between reviewers will be resolved by a third reviewer. Comparisons of dichotomous data will report as the OR and 95% CI, and comparisons of functional and health-related quality of life outcomes are reported as the mean difference and 95% CI and as the risk difference, defined as the difference in the proportion achieving the minimum clinically important difference and 95% CI. As this overview will contribute to orthopaedic surgeons and health managers in better decision-making for the treatment of these fractures. The authors plan to complete the searches and analyses by 30 November 2021. ETHICS AND DISSEMINATION: Ethical approval was obtained at Federal University of Sao Paulo. Findings will be disseminated through peer-reviewed publication. PROSPERO REGISTRATION NUMBER: CRD42021237885.

Glenoid failure after total shoulder arthroplasty with cemented all-polyethylene versus metal-backed implants: a systematic review protocol.

INTRODUCTION: Anatomical total shoulder arthroplasty (TSA) is an effective treatment adopted for patients with glenohumeral osteoarthritis (OA). The glenoid component failure is the main risk that occurs in this therapeutic choice; however, doubts remain regarding the selection of the best implant for avoiding complication. This systematic review aims to evaluate the glenoid component in TSA by comparing the complications of different types of implants. METHODS AND ANALYSIS: A systematic review of randomised clinical trials or quasi-randomised trials will be performed by applying the Preferred Reporting Items for Systematic Review and Meta-Analysis protocols and comparing polyethylene (keeled and pegged) versus metal-backed implants in adult patients with glenohumeral OA. Our search strategy will be performed using MEDLINE, PubMed, Cochrane Central Register of Controlled Trials, EMBASE and Web of Science. Data management and extraction will be performed using a data withdrawal form and by analysing study method characteristics, participant characteristics, intervention characteristics, results and methodological domains. The database search will be performed by February 2021. The Grading of Recommendations Assessment, Development and Evaluation will be used for assessing the quality of evidence of each study selected; however, some critical and important outcomes were determined such as the shoulder function through functional scores (Constant-Murley and American Shoulder and Elbow Surgeons), complications represented by pain (Visual Analogue Scale), surgical revision, radiograph radiolucency and loosening. The confidence in estimated effects for these outcomes will be applied as the overall confidence. The outcomes will be defined as early or late, according to the postoperative follow-up of less than or greater than 1 year, respectively, for complications and radiographs. For the shoulder function, follow-ups will be divided into 6, 12 and 24 months. Heterogeneity is expected in systematic reviews; therefore, the selection of outcomes, as well as the sample size, and specific statistical analysis can lead to meta-analysis; however, if it fails, narrative evidence synthesis will be conducted. Other analyses such as descriptive, subgroup and sensitivity analyses will be performed whenever possible. This systematic review will, therefore, provide evidence concerning the best clinical practice for avoiding complications. ETHICS AND DISSEMINATION: This study has been approved by the Institutional Review Board of Universidade Federal de São Paulo (protocols 0725/2017, 2.157.415 and 70473017.5.0000.5505), and the findings will be disseminated through peer-reviewed publication and conference presentations. PROSPERO REGISTRATION NUMBER: CRD42018079537.

Clinical outcomes and cost-utility of rotator cuff repair surgery by open and arthroscopic techniques: study protocol for a randomised clinical trial.

INTRODUCTION: Rotator cuff injuries account for up to 70% of pain in the shoulder. However, there remains no consensus on the best surgical treatment for patients with rotator cuff injuries, in terms of the cost-effectiveness and cost-utility of open and arthroscopic methods for rotator cuff repair. The objective of this trial is to compare the efficacy, cost-effectiveness and cost-utility of open and arthroscopic procedures for rotator cuff repair. METHODS AND ANALYSIS: The trial is a two-group, parallel-design, randomised controlled trial. A total of 100 patients with symptomatic rotator cuff lesions will be allocated in either open or arthroscopic technique in a 1:1 ratio, considering smoking (yes or no), lesion size (≤3 cm or >3 cm) and diabetes (present or absent) as stratification factors. All patients will be included in the same rehabilitation programme after the intervention. The primary outcome measure will be the Constant-Murley Score and the EuroQol-5D-3L score at 48 weeks postsurgery. Secondary outcomes include cost-effectiveness, cost-utility, pain, complications and clinical analysis, using the Simple Shoulder Test, Visual Analogue Pain Scale (VAS), integrity of the repair evaluated through MRI, and complications and failures of the proposed methods. For the cost-effectiveness analysis, we will use the VAS and the Constant-Murley Score as measures of effectiveness. For the cost-utility analysis, we will use the EuroQol-5D-3L as a measure of utility in terms of incremental cost per quality-adjusted life-years. ETHICS AND DISSEMINATION: The study has been approved by the local research ethics committee of both institutions: Hospital Israelita Albert Einstein and Hospital Alvorada Moema/Hospital Pró-Cardíaco. The results will be published in a peer-reviewed, open access journal. TRIAL REGISTRATION NUMBER: NCT04146987.

Predicting pain recovery in patients with acute low back pain: a study protocol for a broad validation of a prognosis prediction model.

BACKGROUND: The clinical course of acute low back pain (LBP) is generally favourable; however, there is significant variability in the prognosis of these patients. A clinical prediction model to predict the likelihood of pain recovery at three time points for patients with acute LBP has recently been developed. The aim of this study is to conduct a broad validation test of this clinical prediction model, by testing its performance in a new sample of patients and a different setting. METHODS: The validation study with a prospective cohort design will recruit 420 patients with recent onset non-specific acute LBP, with moderate pain intensity, seeking care in the emergency departments of hospitals in São Paulo, Brazil. The primary outcome measure will be days to recovery from pain. The predicted probability of pain recovery for each individual will be computed based on predictions of the development model and this will be used to test the performance (calibration and discrimination) in the validation dataset. DISCUSSION: The findings of this study will better inform about the performance of the clinical prediction model, helping both clinicians and patients. If the model's performance is acceptable, then future research should evaluate the impact of the prediction model, assessing whether it produces a change in clinicians' behaviour and/or an improvement in patient outcomes. ETHICS AND DISSEMINATION: Ethics were granted by the Research Ethics Committee of the Universidade Cidade de São Paulo, #20310419.4.0000.0064. Study findings will be disseminated widely through peer-reviewed publications and conference presentations.