Dataset Information

Five-Year Follow-up Results of a Randomized Controlled Study Comparing Intramedullary Nailing with Plate Fixation of Completely Displaced Midshaft Fractures of the Clavicle in Adults.

ABSTRACT: Background:Surgical 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. Methods:At 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. Results:The 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. Conclusions:The 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 Evidence:Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

SUBMITTER: Fuglesang HFS

PROVIDER: S-EPMC6400504 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Five-Year Follow-up Results of a Randomized Controlled Study Comparing Intramedullary Nailing with Plate Fixation of Completely Displaced Midshaft Fractures of the Clavicle in Adults.

Fuglesang Hendrik F S HFS Flugsrud Gunnar B GB Randsborg Per-Henrik PH Hammer Ola-Lars OL Utvåg Stein Erik SE

JB & JS open access 20181023 4

<h4>Background</h4>Surgical 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 subgrou ...[more]

PMID: 30882049

Similar Datasets

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.

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.

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.

Dataset Information

Five-Year Follow-up Results of a Randomized Controlled Study Comparing Intramedullary Nailing with Plate Fixation of Completely Displaced Midshaft Fractures of the Clavicle in Adults.

Publications

Five-Year Follow-up Results of a Randomized Controlled Study Comparing Intramedullary Nailing with Plate Fixation of Completely Displaced Midshaft Fractures of the Clavicle in Adults.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets