Dataset Information

Open reduction and plate fixation compared with non-surgical treatment for displaced midshaft clavicle fracture: A meta-analysis of randomized clinical trials.

ABSTRACT:

Backgrounds

There is no consensus concerning whether surgery or non-surgical treatment is preferred for displaced midshaft clavicle fracture. We performed a meta-analysis of randomized controlled trials (RCTs) to compare healing effects and cosmetic results between surgery and non-surgery.

Methods

We retrieved RCTs regarding open reduction and plate fixation (ORPF) and non-surgical method for the treatment of displaced midshaft clavicle fracture published before June 2018 from PubMed, EMBASE and Cochrane Library. The difference between the two treatments was comparatively discussed in aspects of nonunion, malunion, functional outcome, cosmetic results, and complications.

Results

Nine RCTs were included. The results showed that ORPF is advantageous over the non-surgical treatment in terms of nonunion rate (RR, 0.11[95%CI, 0.06-0.23]), malunion rate (RR, 0.16[95%CI, 0.08-0.35]), appearance dissatisfaction rate (RR, 0.35[95%CI 0.23-0.55]), and shoulder appearance defect rate (RR, 0.06[95%CI, 0.02-0.17]). The non-surgical treatment showed lower rate of complication (RR, 1.60[95%CI, 1.02-2.53]) and no significant differences were found between the 2 treatment groups with respect to functional outcome (disabilities of the arm, shoulder and hand (DASH) questionnaire score) (MD, -4.17[95%CI, -9.35 to 1.01]).

Conclusions

This meta-analysis updated previous results. The current findings suggested that ORPF yielded better efficacy than conservation treatment for displaced midshaft clavicle fracture from perspectives of fracture healing and appearance.

SUBMITTER: Qin M

PROVIDER: S-EPMC6531279 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Publications

Open reduction and plate fixation compared with non-surgical treatment for displaced midshaft clavicle fracture: A meta-analysis of randomized clinical trials.

Qin Miao M Zhao Shishun S Guo Wenlai W Tang Li L Li Hangyu H Wang Xuejie X Zhu Zhe Z Sun Tianwen T

Medicine 20190501 20

<h4>Backgrounds</h4>There is no consensus concerning whether surgery or non-surgical treatment is preferred for displaced midshaft clavicle fracture. We performed a meta-analysis of randomized controlled trials (RCTs) to compare healing effects and cosmetic results between surgery and non-surgery.<h4>Methods</h4>We retrieved RCTs regarding open reduction and plate fixation (ORPF) and non-surgical method for the treatment of displaced midshaft clavicle fracture published before June 2018 from Pub ...[more]

PMID: 31096481

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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: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:IntroductionOpen reduction and internal fixation (ORIF) of displaced midshaft clavicle fractures is associated with higher union rates and earlier functional recovery. However, ORIF with plate fixation is associated with complications including implant irritation and implant failure. Dual plate fixation provides fixation in orthogonal planes, and uses a lower profile fixation technique in comparison to pre-contoured and surgeon-contoured small-fragment locking plates, which may be more prominent. The objective of this study was to conduct a systematic review to summarize outcomes and complications associated with surgical fixation of displaced acute midshaft clavicle fractures with dual plate fixation.MethodsUsing a predetermined study protocol in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines, the databases MEDLINE, EMBASE, and CENTRAL were searched from inception to 2020 to identify studies reporting outcomes in acute midshaft clavicle fractures treated with dual plate fixation. All clinical studies which reported on outcomes of dual plating in patients with acute midshaft clavicle fractures were included. Baseline demographics, plate fixation constructs, fracture union rates, implant removal rates, maintenance of reduction, symptomatic implant rates, wound complications, and functional outcomes were extracted. All extracted data were recorded, and descriptive statistics were summarized. Meta-analysis was performed on fracture union rates and implant removal rates using random-effects modeling using Mantel-Haenszel weighting.ResultsOur literature search identified 2226 unique abstracts, of which eight studies met our study inclusion criteria following review. A total of 278 patients made up of 79.8% male with an average age of 36.0 years were included. The overall dual plate implant removal rate was 4.2% with excellent rates of union reported. Moreover, single plate fixation was associated with a 3.9-fold increased implant removal rate compared to dual plate fixation.ConclusionResults from this systematic review demonstrate that ORIF of displaced midshaft clavicle fractures using a dual plate fixation technique is a viable option to reduce the incidence of implant removal, without negatively impacting the rate of fracture union.Level of evidenceTherapeutic Level III.

Dataset Information

Open reduction and plate fixation compared with non-surgical treatment for displaced midshaft clavicle fracture: A meta-analysis of randomized clinical trials.

Backgrounds

Methods

Results

Conclusions

Publications

Open reduction and plate fixation compared with non-surgical treatment for displaced midshaft clavicle fracture: A meta-analysis of randomized clinical trials.

Similar Datasets

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