RESUMO
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.
Assuntos
Lesões do Manguito Rotador , Síndrome de Colisão do Ombro , Humanos , Manguito Rotador , Lesões do Manguito Rotador/tratamento farmacológico , Dor de Ombro/tratamento farmacológico , Síndrome de Colisão do Ombro/tratamento farmacológico , Projetos de Pesquisa , Metanálise como Assunto , Revisões Sistemáticas como AssuntoRESUMO
INTRODUCTION: Fractures of the diaphysis of the clavicle are common; however, treatment guidelines for this condition are lacking. Surgery is associated with a lower risk of non-union and better functional outcomes but a higher risk of complications. Open reduction and internal fixation with plates and screws are the most commonly performed techniques, but they are associated with paraesthesia in the areas of incisions, extensive surgical exposure and high rates of implant removal. Minimally invasive techniques for treating these fractures have a lower rate of complications. The aim of this study is to evaluate which surgical treatment option (minimally invasive osteosynthesis or open reduction and internal fixation) has better prognosis in terms of complications and reoperations. METHODS AND ANALYSIS: The study proposed is a multicentric, pragmatic, randomised, open-label, superiority clinical trial between minimally invasive osteosynthesis and open reduction and internal fixation for surgical treatment of patients with displaced fractures of the clavicle shaft. In the proposed study, 190 individuals with displaced midshaft clavicle fractures, who require surgery as treatment, will be randomised. The assessment will occur at 2, 6, 12, 24 and 48 weeks, respectively. The primary outcome of the study will be the number of complications and reoperations. For sample size calculation, a moderate effective size between the techniques was considered in a two-tailed test, with 95% confidence and 90% power. Complications include cases of infection, hypertrophic scarring, non-union, refracture, implant failure, hypoesthesia, skin irritation and shoulder pain. Reoperations are defined as the number of surgeries for pseudoarthrosis, implant failure, infection and elective removal of the implant. ETHICS AND DISSEMINATION: Study approved by the institutional ethics committee (number 34249120.9.0000.5505-V.3). The results will be disseminated by publications in peer-reviewed journals and presentations in medical meetings. TRIAL REGISTRATION NUMBER: RBR-3czz68)/UTN U1111-1257-8953.
Assuntos
Clavícula , Fraturas Ósseas , Placas Ósseas , Clavícula/cirurgia , Diáfises , Fixação Interna de Fraturas , Consolidação da Fratura , Fraturas Ósseas/cirurgia , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Retrospectivos , Resultado do TratamentoRESUMO
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.
Assuntos
Lesões do Manguito Rotador , Manguito Rotador , Artroscopia , Humanos , Anos de Vida Ajustados por Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Manguito Rotador/cirurgia , Lesões do Manguito Rotador/cirurgia , Ombro , Resultado do TratamentoRESUMO
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.