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Category:   AnkleIntroduction/Purpose:   Syndesmotic disruption occurs in nearly 1 in 5 ankle fractures and requires anatomic reduction and internal stabilization to maximize functional outcomes. There is growing evidence to support retaining syndesmotic hardware from both a functional and economic standpoint. However, although broken screws are typically of little consequence, the location of screw breakage can be unpredictable and cause painful bony erosion and difficulty with extraction. The purpose of this investigation is to report early clinical and radiographic outcomes of patients who underwent syndesmotic fixation using a novel metal screw with a more predictable break point and design features to allow for easier extraction.Methods:   We performed a retrospective review of all consecutive patients who underwent syndesmotic fixation utilizing the novel syndesmotic screw over a one year period. Demographic data were obtained such as age, gender, fracture classification and relevant comorbidities. Screw specific data were obtained such as number of screws utilized and length. Screw loosening or breakage was documented. Postoperative radiographs were reviewed and tibiofibular overlap, tibiofibular clear space and medial clear space were measured.Results:   18 patients met inclusion criteria. Mean length of clinical follow-up was 4.67 months (range 0.5 to 8.5 months). Per the Lauge Hansen classification, 14 injuries were supination external rotation type, two were pronation abduction and two pronation external rotation type. Three screws (12.5%) fractured at the break point with no screws fracturing at a different location. 21 screws did not fracture with 10 (42%) of the screws demonstrated to be loose. There was no evidence of syndesmotic diastasis or mortise malalignment on final follow up of the cohort. No screws required removal during the study period. There were no other complications of any type (Table 1).Conclusion:   Early reporting of outcomes is essential to maximize both safety and value in healthcare technology innovation. This study provides the first clinical data on a novel alternative to traditional screws and suture button devices for fixation of syndesmotic injuries. At short-term follow up, there were no complications and the novel screw provided adequate fixation to allow healing and prevent diastasis. While initial results are favorable, longer term follow-up is required to determine whether this novel implant can reduce rates of symptomatic hardware requiring removal, which could ultimately make them more cost- effective than suture-button fixation.

Syndesmotic Fixation Utilizing a Novel Metal Screw: A Retrospective Case Series Reporting Early Clinical and Radiographic Outcomes