BACKGROUND: Clavicle fractures are common and usually heal without complications. In this study, we evaluated the outcomes of non-operative versus operative management of displaced fractures. METHODS: In a prospective clinical trial study, sixty-five patients with displaced clavicle mid-shaft fractures were non-randomly divided in two treatment groups. The first group underwent non-operative treatment with figure of 8 bandage (30 patients), and the other underwent operative treatment with plate fixation (35 patients). Figure of 8 bandage and 3.5 millimeter DCP plate with at least six cortical screws were used in non-operative and operative groups respectively. We followed up all patients at weeks 2, 6 and 12, and at month sixth. In addition to clinical examination and x-ray evaluation, we assessed satisfaction, DASH and Constant Shoulder Score for each individual. RESULTS: The average durations of union were 19.3 and 24.4 weeks in operative and non-operative groups respectively (P=0.006). Satisfaction with operative treatment was 74.3% and with non-operative treatment was 66.7%, showing no significant difference (P=0.500). The non-union rate was 5.7% in the operative group and 13.3% in the non-operative group (P=0.518). A significant difference between the two groups in terms of DASH and Constant Shoulder Scores after the six-month follow-up was not found (P=0.352). CONCLUSIONS: According to our results, we recommend operative treatment in mid-shaft clavicle fractures only when there is a definitive indication.
RCT Entities:
BACKGROUND: Clavicle fractures are common and usually heal without complications. In this study, we evaluated the outcomes of non-operative versus operative management of displaced fractures. METHODS: In a prospective clinical trial study, sixty-five patients with displaced clavicle mid-shaft fractures were non-randomly divided in two treatment groups. The first group underwent non-operative treatment with figure of 8 bandage (30 patients), and the other underwent operative treatment with plate fixation (35 patients). Figure of 8 bandage and 3.5 millimeter DCP plate with at least six cortical screws were used in non-operative and operative groups respectively. We followed up all patients at weeks 2, 6 and 12, and at month sixth. In addition to clinical examination and x-ray evaluation, we assessed satisfaction, DASH and Constant Shoulder Score for each individual. RESULTS: The average durations of union were 19.3 and 24.4 weeks in operative and non-operative groups respectively (P=0.006). Satisfaction with operative treatment was 74.3% and with non-operative treatment was 66.7%, showing no significant difference (P=0.500). The non-union rate was 5.7% in the operative group and 13.3% in the non-operative group (P=0.518). A significant difference between the two groups in terms of DASH and Constant Shoulder Scores after the six-month follow-up was not found (P=0.352). CONCLUSIONS: According to our results, we recommend operative treatment in mid-shaft clavicle fractures only when there is a definitive indication.
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