Open reduction and plate fixation versus sling in treatment of mid-shaft fractures of clavicle: A prospective randomized study protocol

BACKGROUND: For this prospective randomized clinical trial, it is implemented for the comparison of the outcomes of open reduction and internal fixation versus the sling treatment for mid-shaft clavicle fractures. METHODS: We will evaluate the eligible patients diagnosed with the mid-shaft clavicle fractures in our hospital from December 2020 to December 2021. The outcomes acquired were reported in accordance with the guidelines of Consolidated Standards of Reporting Trials (CONSORT). Approval for this prospective randomized clinical trial was obtained from the institution alethics review committee of Wuzhong People's Hospital. The criteria for inclusion included: one third of clavicle fracture with at least 1 axial width displacement (Robinson type 2B2 or 2B1); agreed to take part in our research; over 18 years of age; patients with isolated clavicle fracture. While the criteria for exclusion contained: the medial or lateral segment clavicle fracture; open fracture; injuries related to neurovascular; over 21 days of changes from accident. The primary outcome was described as the evidence of nonunion at 1 year, which was defined as the intact bone bridge without X-ray fracture after more than 6 months. The secondary outcomes included the function of arm, overall health, adverse events, the satisfaction related to appearance, and pain. CONCLUSIONS: It was hypothesized that in the case of clavicular comminuted mid-shaft fracture, for the open reduction and internal fixation, its nonunion rate was lower and satisfaction rate was higher, although there were a variety of complications. TRIAL REGISTRATION: This study protocol was registered in Research Registry (researchregistry6295).