Plate fixation or intramedullary fixation for midshaft clavicle fractures: a systematic review and meta-analysis of randomized controlled trials and observational studies

Houwert, Roderick M.; Smeeing, Diederik P.J.; Ali, Usama Ahmed; Hietbrink, Falco; Kruyt, Moyo C.; Meijden, Olivier A. van der

doi:10.1016/j.jse.2016.01.018

Cited by 72 publications

(69 citation statements)

References 43 publications

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“…RCTs in surgery may not always be ethical, feasible, or necessary to address a particular research question. If so, properly designed and conducted observational studies can be valuable alternatives for an RCT and produce credible results [7][8][9][10][11]. In this paper, we elaborate on complementary use of observational studies and RCTs and the need for both.…”

Section: Introductionmentioning

confidence: 99%

Study methodology in trauma care: towards question-based study designs

Houwert

Beks

Dijkgraaf

et al. 2019

Eur J Trauma Emerg Surg

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The randomized controlled trial (RCT) in surgery may not always be ethical, feasible, or necessary to address a particular research question about the effect of a surgical intervention. If so, properly designed and conducted observational (nonrandomized) studies may be valuable alternatives for an RCT and produce credible results. In this paper, we discus differences between RCTs and observational studies and differentiate between three types of comparisons of surgical interventions. We assert that results of different designs should be regarded as complementary to each other when evaluating surgical interventions. Criteria for credible observational research are presented to provide guidance for future observational research of surgical interventions. We argue that the research question that is being asked should guide the discussion about the value of a particular study design.

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Section: Introductionmentioning

confidence: 99%

Study methodology in trauma care: towards question-based study designs

Houwert

Beks

Dijkgraaf

et al. 2019

Eur J Trauma Emerg Surg

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“…Due to the primary bone healing without callus formation and due to periosteal damage by the plate, a relevant risk of refracture after plate removal is described [34]. We do not expect the same rate of refractures after nailing like shown for clavicle fractures [30,35]. Despite the mentioned improvements of the implants and good biomechanical and clinical results, locked ulna nailing is not a frequently used treatment option.…”

Section: Discussionmentioning

confidence: 99%

Nailing of diaphyseal ulna fractures in adults—biomechanical evaluation of a novel implant in comparison with locked plating

et al. 2020

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Background: Adult forearm fractures require surgical treatment in most cases. Open reduction and internal fixation with plate osteosynthesis is the therapy of choice. Intramedullary fixation offers several advantages compared to plate fixation but is not routinely used. The aim of our study was to compare a newly designed ulna nail with angular stable plating in a biomechanical testing setup of an ulna shaft fracture with a diaphyseal defect. Methods: Ten pairs of sawbones with a defect osteotomy of the ulna shaft (OTA 2U2C3) were fixed with an interlocked nail or locked plate osteosynthesis. The constructs were tested under four-point bending, torsional loading and axial loading in a servo-pneumatic testing machine to compare the stiffness of both stabilization methods.Results: The nail constructs show lower yet sufficient bending stiffness (62.25 ± 6.64 N/mm) compared to the plate constructs (71.2 ± 5.98 N/mm, p = 0.005). The torsional loading test shows superior stiffness of the plate constructs (0.24 ± 0.03 Nm/deg vs. 0.1 ± 0.01 Nm/deg; p < 0.001), while the axial loading shows superior stiffness of the nail constructs (1028.9 ± 402.1 N/mm vs. 343.9 ± 112.6 N/mm; p < 0.001).Conclusions: Intramedullary nailing of ulna shaft fractures obtains sufficient but lower stability in bending and torsional loading when compared to rigid angular stable plating and could be an alternative technique to plate fixation. The lower stability and the closed stabilization technique allow for a rapid periosteal healing, which is not present in stiffer constructs.

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“…In the last years multiple meta-analysis comparing the gold standard of plate fixation and intramedullary devices (irrespective of device or plate type) for the management of midshaft clavicle fractures have been published. [82][83][84][85][86][87][88][89] These studies report similar [82][83][84][86][87][88] or superior [85,89] functional outcomes and union rates in the intramedullary fixation group. Furthermore, most report a higher rate of complications (such as infection, refracture rate) and increased surgical time when using plate fixation, making an evaluation of the devices described in the present study even more relevant.…”

Section: Discussionmentioning

confidence: 99%

Functional Outcomes and Complications of Intramedullary Fixation Devices for Midshaft Clavicle Fractures: A Systematic Review and Meta-Analysis.

Hoogervorst¹,

Dam²,

Hannink³

2020

Preprint

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Background An 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. 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.Methods A 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.Results Sixty-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).Conclusion Although 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 devicespecific 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.3

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Plate fixation or intramedullary fixation for midshaft clavicle fractures: a systematic review and meta-analysis of randomized controlled trials and observational studies

Cited by 72 publications

References 43 publications

Study methodology in trauma care: towards question-based study designs

Study methodology in trauma care: towards question-based study designs

Nailing of diaphyseal ulna fractures in adults—biomechanical evaluation of a novel implant in comparison with locked plating

Functional Outcomes and Complications of Intramedullary Fixation Devices for Midshaft Clavicle Fractures: A Systematic Review and Meta-Analysis.

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