Platelet-rich plasma combined with conventional surgery in the treatment of atrophic nonunion of femoral shaft fractures: study protocol for a prospective, randomized, controlled clinical trial

Abstract

Background: Internal and external fixation combined with autologous bone graft for the treatment of atrophic nonunion has a long treatment cycle, and there remain cases where the nonunion cannot be cured. Platelet-rich plasma contains a variety of growth factors and a large number of white blood cells, and contributes to tissue healing. However, there have been no clinical studies on the effectiveness of platelet-rich plasma combined with conventional surgery in the treatment of atrophic nonunion. Methods/Design: We conducted a prospective, open-label, randomized, controlled clinical trial at the Affiliated Hospital of Qinghai University, China. Ninety-two patients with atrophic nonunion of femoral shaft fractures were equally and randomly divided into a control group and an experimental group. The patients in the control group received conventional surgery, while the patients in the experimental group were injected with autologous platelet-rich plasma in addition to receiving conventional surgery. The primary outcome was fracture healing rate at 9 months postoperatively. The secondary outcomes were visual analogue scale scores for resting state and passive motion, healing time, treatment costs, and adverse reactions. Our partial results revealed that the visual analogue scale scores and complications were similar between the two groups on postoperative days 1–3. The healing rate was significantly higher in the experimental group compared with the control group. The healing time was significantly shorter in the experimental group compared with the control group. Discussion: The present trial was designed in August 2014, and case recruitment was completed in September 2016. Data for the last case will be collected in June 2018, and the data analysis will be completed in December 2018. The trial will provide objective data on the clinical use of platelet-rich plasma combined with conventional surgery for the treatment of atrophic nonunion. Trial registration: ClinicalTrials.gov identifier: NCT03129971. Ethics: The study protocol has been approved by the Ethics Committee of Affiliated Hospital of Qinghai University of China (approval number: QHG0223A). Informed consent: Written informed consent was obtained from all participants.