Dataset Information

Functional outcomes, union rate, and complications of the Anser Clavicle Pin at 1 year: a novel intramedullary device in managing midshaft clavicle fractures.

ABSTRACT: 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.

SUBMITTER: Hoogervorst P

PROVIDER: S-EPMC7256888 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Functional outcomes, union rate, and complications of the Anser Clavicle Pin at 1 year: a novel intramedullary device in managing midshaft clavicle fractures.

Hoogervorst Paul P Konings Peer P Hannink Gerjon G Holla Micha M Schreurs Wim W Verdonschot Nico N van Kampen Albert A

JSES international 20200304 2

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

PMID: 32490413

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:Intramedullary fixation of comminuted mid-shaft clavicle fractures has traditionally been employed with satisfactory clinical outcomes; however, pins with smooth surfaces may protrude from the bone and are prone to migration, while some threaded pins are difficult to remove post-operatively. The aim of this proof-of-concept study was to develop and evaluate the biomechanical strength of a novel intramedullary Echidna pin device designed to maintain fracture reduction, resist migration and facilitate ease of post-operative removal.Thirty human clavicle specimens were harvested and fractured in a comminuted mid-shaft butterfly configuration. Each specimen was randomly allocated to three surgical repair groups including intramedullary fixation using the Echidna pin and Herbert Cannulated Bone Screw System, as well as plate fixation using bi-cortical locking screws. Using a biomechanical testing apparatus, construct bending and torsional stiffness were measured, as well as ultimate bending strength.There was no significant difference in torsional stiffness and ultimate bending moment between the Echidna pin and Herbert screw repair constructs (p > 0.05); however, the Echidna pin construct demonstrated a significantly greater bending stiffness compared to that of the Herbert screw construct (mean difference 0.55 Nm/deg., p = 0.001). The plate construct demonstrated significantly greater torsional stiffness, bending stiffness and ultimate bending moment compared to those of the Herbert screw and Echidna pin (p < 0.05).An intramedullary Echidna pin device was designed to stabilize comminuted fractures of the clavicle, maintain fracture compression and provide ease of removal post-operatively. Since the results suggest equivalent or superior torsional and bending stability in the Echidna pin compared to that of the Herbert screw, the Echidna pin concept may represent an alternative fixation device to conventional intramedullary screws, nails and pins; however, superior plating using bi-cortical locking screws provides substantially higher construct structural rigidity than intramedullary devices, and may therefore be useful in cases of osteoporotic bone, or where high fracture stability is required.

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. Plate fixation and intramedullary fixation are the most commonly used surgical treatment options for mid-shaft clavicle fractures; the latter method has demonstrated better performance in some studies. Objectives. Our aim was to critically review and summarize the literature comparing the outcomes of mid-shaft clavicle fracture treatment with plate fixation or intramedullary fixation to identify the better approach. Search Methods. Potential academic articles were identified from the Cochrane Library, MEDLINE (1966-2015.5), PubMed (1966-2015.5), EMBASE (1980-2015.5) and ScienceDirect (1966-2015.5). Gray studies were identified from the references of the included literature. Selection Criteria. Randomized controlled trials (RCTs) and non-RCTs comparing plate fixation and intramedullary fixation for mid-shaft clavicle fracture were included. Data Collection and Analysis. Two reviewers performed independent data abstraction. The I (2) statistic was used to assess heterogeneity. A fixed- or random-effects model was used for the meta-analysis. Results. Six RCTs and nine non-RCTs were retrieved, including 513 patients in the intramedullary fixation group and 521 patients in the plating group. No significant differences in terms of the union rate and shoulder function were found between the groups. Patients in the intramedullary fixation group had a shorter operative time, less blood loss, smaller wound size, and shorter union time than those in the plating group. With respect to complications, significant differences were identified for all complications and major complications (wound infection, nonunion, implant failures, transient brachial plexopathy, and pain after 6 months). Similar secondary complications (symptomatic hardware, hardware irritation, prominence, numbness, hypertrophic callus) were observed in both groups. Conclusions. Intramedullary fixation may be superior to plate fixation in the treatment of mid-shaft clavicle fractures, with similar performance in terms of the union rate and shoulder function, better operative parameters and fewer complications.

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.

Dataset Information

Functional outcomes, union rate, and complications of the Anser Clavicle Pin at 1 year: a novel intramedullary device in managing midshaft clavicle fractures.

Publications

Functional outcomes, union rate, and complications of the Anser Clavicle Pin at 1 year: a novel intramedullary device in managing midshaft clavicle fractures.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets