Evaluating the safety and feasibility of a new surgical treatment for forearm fractures in older children: study protocol for a randomised controlled trial

BACKGROUND: Both-bone forearm fractures are a common fracture, accounting for 3.4% of all paediatric fractures. For now, elastic stable intramedullary nailing (ESIN) and open reduction and internal fixation (ORIF) are the common surgical procedures for paediatric both-bone forearm fractures. Both ORIF and ESIN have their shortcomings. Therefore, we need to find another surgical treatment which can decrease the rate of complications and improve the clinical efficacy. Our study plans to test hybrid fixation, using an ESIN fixation for the radius and an ORIF for the ulna. Our study will conduct a randomised controlled trial (RCT) comparing double plate fixation with hybrid fixation for treatment of both-bone forearm fractures in older children between 10 and 16 years of age. The objectives of this trial are to compare the effectiveness between double plate fixation and hybrid fixation for treatment of both-bone forearm fractures in older children. METHODS: An RCT will be conducted, and the participants included will be randomly divided into either the hybrid fixation group or the double plate fixation group, at a ratio of 1:1. The primary clinical outcome measures are the Disabilities of the Arm, Shoulder and Hand score and radiological evaluation. Secondary clinical outcome measures are intraoperative blood loss, surgical duration, visual analogue scale score after surgery, hospital duration after surgery and complications. Follow-up will be conducted at 2 weeks and 1, 3, 6 and 12 months postoperatively. DISCUSSION: The trial will provide a new surgical treatment for forearm fractures in older children. Our hypothesis is that there is no clinically relevant difference in the primary outcome measures between the two treatment groups. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR1800018060. Registered on 26 August 2018. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3458-5) contains supplementary material, which is available to authorized users.