Fenestration and debridement combined with percutaneous minimally invasive fibula implantation in the treatment of senile degenerative osteonecrosis of the femoral head: a study protocol for a non-randomized controlled trial / 中国组织工程研究

ABSTRACT

BACKGROUND: Osteonecrosis of the femoral head is one of the common forms of senile degenerative osteoarthropathy. The hip preservation surgery techniques that are currently commonly used include femoral head fenestration, debridement and bone grafting through an anterior approach, and debridement and impaction bone grafting with fibula support through a lateral approach with subtrochanter drilling. These two techniques cause great trauma to the patients, and surgery costs are high. Femoral head collapse occurs easily after surgery. The course inhibition of necrosis of the femoral head and repair effect are not ideal. OBJECTIVE: This study hopes to develop a new repair method that can make up for the shortcomings of conventional hip preservation surgery. We will observe the therapeutic effect of fenestration and debridement combined with percutaneous minimally invasive fibula implantation. This low-cost procedure for senile osteonecrosis of the femoral head should have little intraoperative trauma. We will determine if it also prevents postoperative femoral head collapse. METHODS: This is a prospective, multicenter, non-randomized, controlled, clinical trial. Seventy patients (117 hips) with senile degenerative osteonecrosis of the femoral head will be recruited from the Hebei Provincial Youfu Hospital and the Third Hospital of Hebei Medical University, Shijiazhuang, China. The patients will be allocated into three groups according to the repair method. (1) Patients in the drilling debridement group will undergo conventional debridement and impaction bone grafting with fibula support through a lateral approach with subtrochanter drilling. (2) Patients in the fenestration debridement group will undergo conventional femoral head fenestration, debridement, and bone grafting through an anterior approach. (3) Patients in the combination repair group will undergo fenestration, debridement, and impaction bone grafting combined with percutaneous minimally invasive fibula implantation. Each group will include 39 hips. Follow-up will be conducted for 12 months. The primary outcome measure is the incidence of femoral head collapse on the affected side at 12 months after surgery. The secondary outcome measures are intraoperative blood loss, operation time, hospital costs, and Harris hip score for hip function before surgery and 6 and 12 months after surgery and the incidence of adverse reactions at 6 and 12 months after surgery. DISCUSSION: Our results can verify whether the effect of fenestration and debridement combined with percutaneous minimally invasive fibula implantation is better than those of the other two types of conventional hip preservation techniques in the treatment of senile osteonecrosis of the femoral head. In addition, we will validate whether the combined method clearly inhibits postoperative femoral head collapse and improves hip function. This trial has been approved by the Ethics Committee of Third Hospital of Hebei Medical University of China(approval numberKE2016-011-1).The study protocol will be conducted in accordance with the Declaration of Helsinki,formulated by the World Medical Association. Written informed consent will be obtained from all participants. This trial was designed in January 2014. Ethics approval was done in December 2014. The recruitment of subjects will begin in June 2018. Samples and data will be collected from June 2018 to June 2019. Outcome measures will be analyzed in August 2019. This trial will be completed in December 2019. The results of the trial will be reported in a scientific conference or disseminated in a peer-reviewed journal. This trial had been registered in the Chinese Clinical Trial Registry (registration number ChiCTR1800015124).