![]() ![]() The score varies from 0 that represents sick leave or disability pension because of ankle problems to 10 that corresponds to participation in national and international elite competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury. It consists of a graduated list of activities of daily living, recreation, and competitive sports. The Tegner activity level scale is a patient-administered rating system designed to provide a standardized method of grading work and sporting activities. Overall study duration will be 2 years and 6 months (2 years to reach the expected sample size and 6 months to complete the follow-up):Įvaluated by using the Tegner score at 12 and 24 weeks postoperatively. Safety will be monitored throughout the study. Clinical assessments will be performed using subjective, objective and radiological evaluations. Patients with a fracture non-union radiologically confirmed at week 24 will be followed up until 48 weeks after surgery. Subsequent follow-up visits are scheduled at 2, 6, 12 and 24 weeks after surgery. Delayed weight-bearing consists in the limitation of the weight-bearing to 20-30% of patient's total weight using crutches for the first 6 weeks after surgery (also patients of the control group will wear the ankle brace). Postoperatively, patients who still meet the eligibility criteria will be randomized in 2 groups: immediate post-operative complete weight-bearing and complete weight-bearing delayed for 6 weeks.Immediate complete weight-bearing consists in the possibility to undergo all the everyday activities without limiting weight-bearing and without the use of walking aids (patients will wear an ankle brace, this will ensure the safety of the early recovery phases, protecting from dangerous movements while allowing the mobilization in the healthy range of movement). In particular,an anatomical open reduction and internal fixation with one or two compression screws sustained by a neutralization third-tubular plate for simple fractures or a bridging third-tubular locking compression plate for multi-fragmentary fractures will be performed. The surgical operation will be carried out following the AO Foundation general and specific rules concerning the surgical treatment of malleolar fractures. This higher stability gives the possibility to evaluate the benefit of the immediate weight-bearing protocol without safety concerns.Ī power analysis was performed to estimate the required sample size to detect a significant difference in the OMAS score at 6 weeks between groups: the number of patients needed is 42 patients per group (84 patients overall) but, considering the risk of drop-outs, the investigators plan to enroll 20% more patients for a total of 100 patients. Eligible lateral malleolar fractures are limited to Weber A and Weber B fractures, since they have a higher stability, after open reduction and internal fixation, compared to Weber C and Maisonneuve fractures. The study population corresponds to the patients who may benefit from a post-operative rehabilitation protocol with immediate weight-bearing. Why Should I Register and Submit Results?. ![]()
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