Dataset Information

Protocol of BRICS: Brazilian multicentric pragmatic randomised trial of surgical interventions for displaced diaphyseal clavicle fracture study: MIPO versus ORIF for the treatment of displaced midshaft clavicle fractures

ABSTRACT:

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.

SUBMITTER: Mendes Jr. A

PROVIDER: S-EPMC8559127 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundSurgical management of completely displaced midshaft fractures of the clavicle is becoming more frequent, although long-term follow-up with Level-I evidence is scarce. Plate fixation (PF) of comminuted fractures provides faster functional recovery than elastic stable intramedullary nailing (ESIN). The 12-month follow-up of this randomized controlled trial, published previously, found no clinical differences at that time on the group level, but subtle differences on the subgroup level indicated that the results after closed ESIN were better than those after open ESIN. The primary aim of the study reported here was to compare the long-term clinical outcomes and sequelae after open reduction with those after closed reduction and to help surgeons develop a treatment strategy of either PF or ESIN for selected patients.MethodsAt a median follow-up of 66 months (range, 49 to 89 months), the 123 patients in the original study were invited to an online secure survey. We used the survey results to compare the PF and ESIN treatment arms and to perform predetermined subgroup analyses of closed compared with open ESIN in relation to Disabilities of the Arm, Shoulder and Hand (DASH) score, pain assessment, and implant removal.ResultsThe questionnaire was completed by 114 (93%) of the 123 patients. There were no differences between the 2 treatment arms with regard to the DASH score (ESIN, 3.1 ± 7.0 and PF, 3.7 ± 7.5; p = 0.9). The 27 patients who had been treated with closed ESIN had a significantly superior DASH score compared with the 27 patients who had been treated with open ESIN (closed, 0.7 ± 1.4 and open, 5.2 ± 8.9; p = 0.015) and compared with the patients who had been treated with PF (closed ESIN, 0.7 ± 1.4 and PF, 3.9 ± 7.5; p = 0.002). Patients who had been treated with closed ESIN also reported fewer sequelae than patients who had been treated with open ESIN or PF.ConclusionsThe results of this study, combined with those of our prior 1-year follow-up of the same patients, indicate that it seems to be advantageous to perform closed ESIN. The long-term results after PF were similar to those after open ESIN, but PF resulted in faster functional recovery and fewer patients needing to have the implant removed. Therefore, if open reduction is necessary for a comminuted fracture, it seems that the advantages of the minimally invasive ESIN procedure are lost, and the surgeon should consider conversion to PF.Level of evidenceTherapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Project description:Background:Surgical management of displaced midshaft clavicle fractures in adults leads to better union rates, improved early functional outcomes, and increased patient satisfaction compared with nonoperative treatment. However, both intramedullary fixation and plate osteosynthesis are subject to a specific array of disadvantages and complications. The Anser Clavicle Pin is a novel intramedullary device designed to address these disadvantages and complications. The aim of this study was to evaluate the union rate, functional outcomes, and complications of the Anser Clavicle Pin at 1-year follow-up. Methods:A prospective explorative case series including 20 patients with displaced midshaft clavicle fractures was performed in 2 hospitals. The primary outcomes were union rate, functional outcomes (Constant-Murley score and Disabilities of the Arm, Shoulder and Hand score), and complications. The secondary outcomes were closed reduction rate, operative time, image-intensifier time, hospital stay, incision length, time to radiologic union, postoperative pain reduction, reoperation rate, health-related quality-of-life score, and patient satisfaction. Results:There was a 100% union rate. The Constant-Murley score at 1 year was 96.7 (standard deviation [SD], 5). The Disabilities of the Arm, Shoulder and Hand score was 5.1 (SD, 10). There were no infections, neuropathy of the supraclavicular nerve, or hardware irritation requiring removal of hardware. Three device-related complications (15%) occurred, including plastic deformation, protrusion, and hardware failure. The satisfaction score was 8.9 (SD, 1) on the visual analog scale at the 1-year follow-up. Conclusion:Managing displaced midshaft clavicle fractures with the Anser Clavicle Pin results in a 100% union rate and excellent functional outcomes and patient satisfaction. It has a low non-device-related complication rate, and the device-related complications that occurred in this series may be prevented in the future.

Project description:Background:The majority of clavicle fractures are midshaft injuries, although fractures of the distal or medial fragment also occur. The aim of this study was to review the current evidence on these injuries to help inform future treatment plans. Methods:We searched for studies comparing interventions for medial, midshaft, or distal clavicle fractures; however, we did not identify any comparative studies on medial fractures and performed a secondary search on this topic. We conducted Bayesian network meta-analyses, although this was not feasible with studies on medial fractures and we described their results qualitatively. Results:For midshaft fractures, we found statistically significant improvements in function and time to radiographic union with plating, an elastic stable intramedullary nail (ESIN), and the Sonoma CRx intramedullary nail over nonoperative treatments. Both plating and an ESIN also showed significantly lower risks of nonunion and malunion relative to nonoperative methods. For distal fractures, a locking plate (LP) with or without coracoclavicular (CC) suturing yielded significantly better outcomes over K-wires with or without tension bands, CC suturing alone, an LP with a CC screw, a hook plate, and a sling. For medial fractures, plating may result in more favorable functional and union-related outcomes, although implant irritation may occur. In addition, K-wires, tension bands, and a screw with sutures demonstrated success when plating was technically not feasible in a few cases, whereas treatment with a sling may result in reduced function and a higher risk of complications relative to surgery. Conclusion:This study can provide guidance on the management of medial, midshaft, and distal clavicle fractures. The current evidence suggests that plating, an ESIN, and a CRx intramedullary nail are all good options for midshaft fractures; an LP with or without CC suturing should be preferred for distal fractures; and plating is also acceptable for medial fractures, provided that the patient is deemed suitable for surgery and has the adequate bone stock and sufficiently sized medial fragment necessary to implant the device. Patient preferences for certain outcomes should be considered, which may result in different treatment recommendations.

Project description:BackgroundAn alternative to the current gold standard in operative treatment of displaced midshaft clavicle fractures (DMCF) using plate osteosynthesis, is internal fixation by means of intramedullary fixation devices. These devices differ considerably in their specifications and characteristics and an evaluation of their clinical results is warranted. The aim of this systematic review is to generate an overview of functional outcomes and complications in the management of DMCF per available intramedullary device.MethodsA systematic review was conducted to identify all papers reporting functional outcomes, union rates and/or complications using an intramedullary fixation device for the management of midshaft clavicle fractures. Multiple databases and trial registries were searched from inception until February 2020. Meta-analysis was conducted based on functional outcomes and type of complication per type of intramedullary fixation device. Pooled estimates of functional outcomes scores and incidence of complications were calculated using a random effects model. Risk of bias and quality was assessed using the Cochrane risk of bias and ROBINS-I tools. The confidence in estimates were rated and described according to the recommendations of the GRADE working group.ResultsSixty-seven studies were included in this systematic review. The majority of studies report on the use of Titanium Elastic Nails (TEN). At 12?months follow up the Titanium Elastic Nail and Sonoma CRx report an average Constant-Murley score of 94.4 (95%CI 93-95) and 94.0 (95%CI 92-95) respectively (GRADE High). The most common reported complications after intramedullary fixation are implant-related and implant-specific. For the TEN, hardware irritation and protrusion, telescoping or migration, with a reported pooled incidence 20% (95%CI 14-26) and 12% (95%CI 8-18), are most common (GRADE Moderate). For the Rockwood/Hagie Pin, hardware irritation is identified as the most common complication with 22% (95%CI 13-35) (GRADE Low). The most common complication for the Sonoma CRx was cosmetic dissatisfaction in 6% (95%CI 2-17) of cases (GRADE Very low).ConclusionAlthough most studies were of low quality, good functional results and union rates irrespective of the type of device are found. However, there are clear device-related and device-specific complications for each. The results of this systematic review and meta-analysis can help guide surgeons in choosing the appropriate operative strategy, implant and informing their patient.Level of evidenceIV.