Bioabsorbable plating in the treatment of pediatric clavicle fractures: A biomechanical and clinical analysis
Introduction
The clavicle accounts for nearly half of all shoulder fractures in children, and most commonly involves the midshaft region (Postacchini et al., 2002). Treatment of midshaft fractures has traditionally been non-operative except in cases of open fracture or neurovascular compromise. This management strategy was based on findings from the initial adult literature demonstrating overall positive clinical outcomes after non-operative treatment despite persistent radiographic mal-alignment (Nordqvist et al., 1998). However, more recent studies on adult high-velocity trauma fractures suggest that non-operative management may result in poor outcomes including: radiographic shortening, patient dissatisfaction regarding the cosmetic appearance, decreased endurance with shoulder abduction, and upper extremity neurologic symptoms (Hill et al., 1997; McKee et al., 2006; Zlowodzki et al., 2005). Rate of metal plate removal after implantation has been reported to be as high as 30% to 100% in children (Mehlman et al., 2009; Zlowodzki et al., 2005). Studies for the adolescent population have yielded less consistent results, and the clinical treatment strategies remain controversial. Though non-operative fixation may not result in an appreciable difference in function of the injured compared to the non-injured side, plate fixation may decrease symptomatic nonunion rates and decrease time before return to activities (Schulz et al., 2013; Vander Have et al., 2010).
While operative fixation with metal implants has been shown to decrease the rates of non- and malunion at least in the adult population, these constructs are not without their complications. Patients may experience discomfort, paresthesias or overlying skin breakdown at the site of implant placement, especially with superior plating (Kubiak and Slongo, 2002). Dissatisfaction with the appearance of the scar can be an issue in all plate positions. Additionally, fracture through the plate, implant loosening, or deep infection can also occur (Bostman et al., 1997; Poigenfürst et al., 1992). Ultimately, whether required by symptoms or by patient preference, many implants require an additional surgery for removal after the fracture is healed. Complications do not end with implant removal, as patients can re-fracture through the previous fracture site, remnant screw tunnel, or even during the plate removal process (Kubiak and Slongo, 2002; Poigenfürst et al., 1992).
One approach to eliminate the need for implant removal after fracture fixation is the utilization of a bioabsorbable implant. Implants made with biologically absorbable materials have become more popular in orthopaedic surgery and have the advantage of reduced stress shielding (allowing gradual load transfer) and a lower incidence of removal than their metal counterparts (Ambrose and Clanton, 2004; Böstman, 1996). The field of pediatric oral maxillofacial surgery has started to adopt the utilization of bioabsorbable implants over titanium implants for facial reconstruction surgery, particularly for zygomatic arch fractures (Chandra and Zemplenyi, 2017). The reason behind this trend is that the osseous structures are superficial with minimal soft tissue coverage, there is growth potential that could warrant removal of a restrictive metal implant and any requirement of implant removal is suboptimal given the location of the surgical approach. The outcomes of absorbable implants appear to mirror the outcomes seen in children treated with metal implants (both within the failure rates and the aesthetic outcomes) (Mahmoud et al., 2016; Turvey et al., 2011).
The successful utilization of absorbable implants on the facial bones lends to the discussion regarding other potential locations for successful utilization of absorbable implants. The criteria within the realm of orthopaedic surgery includes bones that are superficial in nature, have a high rate of secondary surgery for implant removal, and that during early phases of post-operative course can be managed with activity restrictions. These three criteria maximize the consideration to not use metal implants that have otherwise been demonstrated to be historically successful, such as in the midshaft clavicle fracture. The purpose of this study was to examine the biomechanical properties of failure in a bioabsorbable implant in the fixation of a midshaft clavicle fracture in comparison with those properties of a similarly-tested metal implant from a previous reported study (Robertson et al., 2009) and to determine if the mode of failure for these implants in adolescent clavicle fractures could still retain clinical utility as determined by patient-derived and radiographic outcomes.
Section snippets
Methods
In order to investigate the clinical utility of use of bioabsorbable plates and screws for the treatment of displaced clavicle fractures in adolescents, this study utilized both a biomechanical comparison of bioabsorbable and metal implants and an Institutional Review Board approved retrospective review. Biomechanic testing employed six synthetic clavicles with material characteristics similar to that of live bone, manufactured with simulated mid-shaft fractures (Large left clavicle, 4th
Results
Biomechanic testing yielded the following results (Table 1). The locked bioabsorbable constructs (n = 6, Fig. 2) had significantly lower torsional stiffness (mean 49.3 (SD 13.3) Nmm/°) compared to the locked metal constructs evaluated in the previous study (mean 309.9 (SD 25.0) Nmm/°, P < 0.001). The bioabsorbable implants also had significantly lower maximum cantilever load (mean 81.1 (SD 23.4)N) compared to the metal implants (mean 251.4 (SD 34.4)N, P < 0.0001). There was no significant
Discussion
Bioabsorbable implants for use in orthopaedics are growing in popularity in large part due to the hope of reducing morbidity associated with the prominence and eventual removal often required with superficially-placed metallic implants. The potential trade-off with use of these implants is the reduction of fixation bending strength when compared to traditional metal constructs, although no revision surgeries were required for the bioabsorbable implant cohort within this study. Additionally,
Conclusions
It is clear that the biomechanical strength of absorbable plates to fix a clavicle are inferior to metal plates; but, in adolescence, the outcomes of treatment with absorbable implants can be considered excellent by patient-derived outcome questionnaires. We cannot recommend the routine utilization of this particular absorbable plate and screw construct for midshaft clavicle fracture fixation over traditional metal implants due to lower failure strength and the radiographic evidence of malunion
Acknowledgements
James D. Bomar MPH for figure preparation, John F. Munch III MPA and M. Morgan Dennis BS for IRB assistance and clinical data retrieval, and Tracey P. Bastrom MA for statistical analysis.
Sources of support
This work was supported by a grant from the University of California, San Diego Academic Senate (#RM125H-HULL) and by Rady Children's Hospital-San Diego Orthopedic Research and Education Foundation. Inion Inc. (Weston, FL, USA) supplied implants and use of instrumentation. Implants were supplied by Arthrex Inc., Naples, FL. Research support was obtained from the Orthopedic Division of Children's Specialists of San Diego.
Disclosures
In accordance with the Uniform Requirements, no potential conflicts exist. Full disclosures are listed below:
Emily Osborn, Christine Farnsworth and Joshua Doan have no disclosures to report.
Eric William Edmonds, MD has the following Disclosures:
American Orthopaedic Society for Sports Medicine: Board or committee member
Pediatric Orthopaedic Society of North America: Board or committee member
DePuy, A Johnson & Johnson Company: Research support
Ossur: Paid presenter or speaker.
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