Elastic Stable Intramedullary Nailing Versus Nonoperative Treatment of Displaced Midshaft Clavicular Fractures-A Randomized, Controlled, Clinical Trial

From the Department of Trauma Surgery and Sports Medicine, Innsbruck Medical University, Innsbruck, Austria.
Journal of orthopaedic trauma (Impact Factor: 1.8). 03/2009; 23(2):106-12. DOI: 10.1097/BOT.0b013e318190cf88
Source: PubMed


To compare elastic stable intramedullary nailing (ESIN) with nonoperative treatment of fully displaced midshaft clavicular fractures in adults.
The study was a randomized, controlled, clinical trial.
Level 1 trauma center.
Sixty patients between 18 and 65 years of age participated and completed the study. They were randomized to either operative or nonoperative treatment with a 2-year follow-up.
Thirty patients were treated with a simple shoulder sling and 30 patients with ESIN within 3 days after trauma.
Complications after operative and nonoperative treatments, Disabilities of the Arm, Shoulder and Hand (DASH) score and Constant Shoulder Score for outcome measurement, and clavicular shortening.
Fracture union was achieved in all patients in the operative group, whereas nonunion was observed in 3 of 30 patients of the nonoperative group. Two symptomatic malunions required corrective osteotomy in the nonoperative group. Medial nail protrusion occurred in 7 cases in the operative group. Implant failure with revision surgery was necessary in 2 patients after an additional adequate trauma. DASH scores were lower in the operative group throughout the first 6 months and 2 years after trauma, with a significant difference during the first 18 weeks. Constant scores were significantly higher after 6 months and 2 years after intramedullary stabilization. Patients in the operative group showed a significant improvement of posttraumatic clavicular shortening; they were also more satisfied with cosmetic appearance and overall outcome.
ESIN of displaced midshaft clavicular fractures resulted in a lower rate of nonunion and delayed union, a faster return to daily activities, and a better functional outcome. Clavicular shortening was significantly lower, and overall satisfaction was higher in the operative group.

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    • "Injury patterns were classified according to OTA/AO (Orthopaedic Trauma Association/Arbeitsgemeinschaft fur Osteosynthesefragen) classification [[20]]. Based on reported clavicle union rates at 10 to 16 weeks following operative fixation [[3],[7],[12],[21]], a nonunion was defined as a painful, persistent fracture line with no radiographic progression of healing over three consecutive months with or without fixation failure which required surgical revision. A malunion was defined as a fracture that achieved a malpositioned bony union stable from the initial reduction and fixation or a reduction that changed with time. "
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    ABSTRACT: Background The purpose of this study was to evaluate surgical healing rates, implant failure, implant removal, and the need for surgical revision with regards to plate type in midshaft clavicle fractures fixed with 2.7-mm anteroinferior plates utilizing modern plating techniques.Methods This retrospective exploratory cohort review took place at a level I teaching trauma center and a single large private practice office. A total of 155 skeletally mature individuals with 156 midshaft clavicle fractures between March 2002 and March 2012 were included in the final results. Fractures were identified by mechanism of injury and classified based on OTA/AO criteria. All fractures were fixed with 2.7-mm anteroinferior plates. Primary outcome measurements included implant failure, malunion, nonunion, and implant removal. Secondary outcome measurements included pain with the visual analog scale and range of motion. Statistically significant testing was set at 0.05, and testing was performed using chi-square, Fisher¿s exact, Mann¿Whitney U, and Kruskall-Wallis.ResultsImplant failure occurred more often in reconstruction plates as compared to dynamic compression plates (p¿=¿0.029). Malunions and nonunions occurred more often in fractures fixed with reconstruction plates as compared to dynamic compression plates, but it was not statistically significant. Implant removal attributed to irritation or implant prominence was observed in 14 patients. Statistically significant levels of pain were seen in patients requiring implant removal (p¿=¿0.001) but were not associated with the plate type.Conclusions Anteroinferior clavicular fracture fixation with 2.7-mm dynamic compression plates results in excellent healing rates with low removal rates in accordance with the published literature. Given higher rates of failure, 2.7-mm reconstruction plates should be discouraged in comparison to stiffer and more reliable 2.7-mm dynamic compression plates.
    Full-text · Article · Jul 2014 · Journal of Orthopaedic Surgery and Research
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    • "Studies that have used patient-based outcome measures have described unsatisfactory outcome rates of 25–30%, with complications including neurologic symptoms and functional deficits [2] [9] [12] [15] [19]. Improved patient outcomes, earlier return to function, decreased nonunion and malunion rates, and better cosmesis have all been reported with operative fixation of acute clavicle fractures [13] [16] [17] [20]. Based on these recent studies, the trend has moved towards surgical stabilization of selected clavicle fractures, with operative indications including significant shortening or distraction "
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    ABSTRACT: The recent trend has been toward surgical fixation of displaced clavicle fractures. Several fixation techniques have been reported yet it is unclear which is preferable. We retrospectively reviewed one hundred one consecutive patients with acute midshaft clavicle fractures treated operatively at a level-1 trauma center. Thirty-four patients underwent intramedullary pin fixation and 67 had anatomic plate fixation. The outcomes we assessed were operative time, complications, infection, implant failure, fracture union, range of motion, and reoperation rate. There were 92 males and 9 females with an average age of 30 years (range: 14–68 years). All patients were followed to healing with an average followup of 20 months (range: 15–32 months). While fracture union by six months and range of motion at three months were similar, the overall healing time for pin fixation was shorter . The pin group had more infections and implant failures than the plate group. Intramedullary pin fixation may have improved early results, but there was no long term difference in overall rate of union and achievement of full shoulder motion. The higher rate of implant failure with pin fixation may indicate that not all fracture patterns are amenable to fixation using this device.
    Full-text · Article · Mar 2014
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    • "Many reports point out higher rates of complications – such as shortening, nonunion, deformity, and unsatisfactory patientderived outcomes – in cases of adult displaced mid-shaft clavicle fractures.7-14 Two recent randomized controlled studies have demonstrated superior results in favour of the operative treatment in those cases of completely displaced clavicle fractures in the adult population.15,16 Definitive indications for internal fixation of closed clavicle fractures in adult patients are still debatable. "
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    ABSTRACT: The literature available on patient-orientated outcomes of operative management for clavicle fractures in adolescents is fairly limited. Open surgical treatment of displaced midshaft fractures of the clavicle continues to be a topic of controversy. Traditional treatment of clavicle fractures has been via non-operative methods in both children and adults. Management in adolescent patients remains controversial, and rightly so, as the traditional experience from non-operative methods has been regarded as satisfactory, while the literature on the more recent approach towards fixing some of these fractures is evolving. We present a review of relevant literature.
    Full-text · Article · Jul 2013 · Orthopedic Reviews
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