Biodegradable magnesium screw, titanium screw and direct embedding fixation in pedicled vascularized iliac bone graft transfer for osteonecrosis of the femoral head: a randomized controlled study

Abstract

Abstract Background The use of degradable magnesium screws to fix the bone flap implanted in the treatment of femoral head necrosis has achieved preliminary good therapeutic results. However, there is no conclusive evidence in the study to demonstrate whether biodegradable magnesium screws promote angiogenesis and no comparison has been made between degradable magnesium screws and traditional screws. Objective To investigate the clinical efficacy and safety of biodegradable magnesium screws in pedicled vascularized iliac bone graft transfer (PVIBGT) for osteonecrosis of the femoral head (ONFH). Materials and methods A total of thirty-six patients (37 hips) with ONFH were recruited from March 2020 to July 2022. The study used a single-blind method, and patients who underwent PVIBGT were randomized into three groups: 12 patients (12 hips) were fixed with biodegradable magnesium screws (Group A), 12 patients (13 hips) were fixed with titanium screws (Group B), 12 patients (12 hips) were directly embedded (Group C). The operating time and the length of stay were recorded. Harris scores, radiological examinations (X-ray, CT, DCE-MRI), blood and serum tests were conducted before and after surgery. The gas yield and degradation rates of the magnesium screws were measured at the 3-months and 6-months post-operative follow-ups in Group A. Results There was no statistically significant difference among these three groups in terms of types, gender, age, course of disease, surgical side, operation time, the length of stay (P > 0.05). All patients were followed up for 6 months. The mean Harris scores were higher in all groups 6 months after surgery (P < 0.05). The rates of excellent and good outcomes were 66.7%, 46.2%, and 33.3% in Groups A, B, and C, respectively. PVIBGT and magnesium screws can improve the blood supply of the femoral head via DCE-MRI evaluation. Two patients with poor incision healing received prompt treatment and subsequently recovered well. No adverse events, such as hip infection or deep vein thrombosis, were reported in the patients. The patients had good biocompatibility of magnesium screws, and no fracture of the magnesium screws was observed in Group A. Liver and kidney functions (including serum magnesium) were within normal ranges. The area of the intermuscular air space was 0 cm2 in follow-ups. The degradation rate of the biodegradable magnesium screws was approximately 10.32% at the 3-months follow-up and 13.72% at the 6-months follow-up. Conclusions PVIBGT has a positive effect, especially with regard to improving blood supply of the femoral head. The fixation of biodegradable magnesium screws is reliable and safe in PVIBGT, and promote angiogenesis.