Project description:Fracture of the clavicle is common, accounting for 2.6 to 4.0 % of all fractures, with an overall incidence of 36.5 to 64 per 100,000 per year. Around 80 % of clavicle fractures occur in the middle third of the clavicle. Randomised controlled trials comparing treatment interventions have failed to indicate the best therapeutic practices for these fractures. The objective of this study is to evaluate the effects (benefits and harms) of two commonly-used conservative interventions: the figure-of-eight bandage versus the arm sling as treatments of middle-third clavicle fractures.This project has been designed as a single-centre, two-arm randomised controlled trial that will compare two interventions: figure-of-eight bandage versus the arm sling. We propose to recruit 110 adults, aged 18 years or older, with an acute (less than 10 days since injury) middle-third clavicle fracture. The primary outcomes to be evaluated will be function and/or disability measured by the Disability of the Arm, Shoulder, and Hand (DASH) questionnaire. In order to assess the secondary outcomes, the Modified University of California at Los Angeles (modified - UCLA) Shoulder Rating Scale will be used. The occurrence of pain (Visual Analogue Scale for pain (VAS)), treatment failure, adverse events and the ability to return to previous activities will also be recorded and evaluated as secondary outcomes.the primary outcome DASH score and the secondary outcomes - modified UCLA and VAS scores - will be analysed graphically. We will apply generalised mixed models with the intervention groups (two levels), and time-point assessments (seven levels) as fixed effects and patients as a random effect.According to the current literature there is very limited evidence from two small trials regarding the effectiveness of different methods of conservative interventions for treating clavicle fractures. This is the first randomised controlled trial comparing the figure-of-eight bandage versus the arm sling for treating clavicle fractures that follows the CONSORT Statement guidelines.ClinicalTrials.gov NCT02398006 .

Project description:IntroductionFractures 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 analysisThe 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 disseminationStudy 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 numberRBR-3czz68)/UTN U1111-1257-8953.

Project description:Background:In this study, we aimed to evaluate the clinical effects of multiple rib fracture treatments using a rib plate fixator. Methods:From June 2014 to December 2016, 110 cases of patients with multiple rib fractures were collected for our study from the 105th Hospital of PLA; 59 patients were treated by surgery, and 51 patients received conservative treatment. We compared surgical rib plate fixation with conservative treatment for patients with multiple rib fractures. Results:The hospital stay for the surgical group was 13.12±4.21 days, whereas for the conservative group, it was 18.57±5.39 days (P<0.001). The duration of the thoracic intensive care unit (ICU) stay was 4.02±1.41 days in the surgical group and 5.06±1.80 days in the conservative group (P=0.001). The indwelling thoracic drainage tube time was 5.85±1.52 days in the surgical group and 8.26±1.96 days in the conservative group (P<0.001). The index of partial pressure of arterial oxygen (PaO2) was 91.05±10.88 mmHg 24 h after surgery whereas 86.49±11.69 mmHg 24 h after conservative treatment (P=0.036). The index of partial pressure of carbon dioxide (PaCO2) was 37.80±2.86 mmHg 24 h after surgery and it was 39.08±2.46 mmHg 24 h after conservative treatment. The hospitalization cost was 6,206.44±371.42 USD for the surgical group and 4,544.61±524.79 USD for the conservative group (P<0.001). The number of rib displacement cases after treatment was 1 case in the surgical group and 2 cases in the conservative group (P=0.475). Atelectasis occurred in 10 cases in the surgical group and in 17 cases in the conservative group (P=0.046). Delayed hemopneumothorax occurred in 7 cases in the surgical group and in 16 cases in the conservative group (P=0.012). Conclusions:Surgical treatment is a safe and effective therapy for multiple rib fractures. Our data suggested that surgical treatment can significantly shorten the patients' pain-endurance time, hospitalization time, and can reduce complication incidence. Severe rib fracture patients might benefit from surgical fixation.

Dataset Information

Surgical versus conservative interventions for treating fractures of the middle third of the clavicle.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets