[Surgical Treatment of Clavicle Midshaft Fractures - Prospective Randomized Trial].

PURPOSE OF THE STUDY Comparison of the outcomes of clavicle midshaft fractures using two different surgical techniques, namely intramedullar osteosynthesis using elastic stable intramedullary nailing (ESIN) with medial cap and extramedullar plate osteosynthesis. MATERIAL AND METHODS The prospective randomized trial was conducted at the Department of Trauma Surgery of the Department of Surgery of the University Hospital Hradec Králové in the Czech Republic at the Level I Trauma Center between 2014 and 2018 and compared two types of osteosynthesis of clavicle midshaft fractures. 60 patients were enrolled in the study and were randomly assigned to one of the two groups. In Group 1, the participants were treated by ESIN and in Group 2 by plate osteosynthesis. The operative technique was chosen by the sealed envelope method. According to the randomization list created by a specialised statistical company, every envelope was marked with a unique number and contained the intramedullar "IM", or the extramedullar "EM" sign. RESULTS The observation of statistical parameters by unpaired t test detected significantly different results: a shorter incision using ESIN osteosynthesis (median = 2.9 cm) compared with plate osteosynthesis (median 14 cm, p < 0.001), longer X-ray exposure using ESIN (median = 325 s) compared with plate osteosynthesis (median = 16.5 s, p < 0.001) and radiation dose using ESIN (median = 996 cGy/cm2) compared with plate osteosynthesis (median = 4 cGy/cm2, p < 0.001). The difference in other parameters such as operative time, in-patient length of stay and duration of rehabilitation was not statistically significant. The time to clavicle fracture repair was comparable in both the surgical arms, i.e. approximately 3 months. Also, the duration of incapacity for work was not statistically different. Functional Constant Shoulder Score at a one-year followup is comparable in both the two arms (p = 0.268). The Dunn s method necessitated a longer operative time when treating multifragmental midshaft clavicle fracture by the ESIN compared to simple fractures. No statistically significant difference was detected in the operative time of different procedures and in the number of bone fragments. The functional outcome was excellent in 25 patients (83%) in each method. DISCUSSION Most midshaft clavicle fractures are still treated non-operatively with good outcomes. The indication for surgical treatment is the dislocation of fragments greater than the width of the clavicle bone, the shortening of fragments greater than 2 cm and the angulation of more than 30°. Patient after operative treatment profits from bone healing by absolute or relative stability. In recent years, new intramedullar techniques other than open plate reduction and fixation have emerged. For example, elastic stable intramedullary titan nailing. Both the methods are full-fledged without functional differences in longterm follow-up. CONCLUSIONS We consider the intramedullar osteosynthesis to be the most appropriate surgical approach for simple midshaft spiral, oblique and transverse clavicle fractures and also wedge oblique fractures. Plate osteosynthesis is useful for all types of fractures. No statistically significant difference in the rate of bone healing was observed after intramedullar or extramedullar ostesynthesis, but multifragmentary fractures healed faster when plate osteosynthesis was used. The determining factor for the received radiation dose is solely the surgical method, not the type of fracture. There is a statistically significant difference in shorter X-ray exposure and lower received radiation dose in plate fixation and reduction. The complication rate is comparable in both the methods. Key words: elastic stable intramedullary nailing, midshaft clavicle fracture, ESIN, TEN, titan elastic nail, clavicle plate osteosynthesis, 3.5 LCP clavicular plate, indication for midshaft fracture treatment.