Objective  To investigate the safety and efficacy of a new biodegradable magnesium internal fixation screw for vascularized iliac bone flap grafting in treatment of osteonecrosis of the femoral head (ONFH). Methods  Patients with ONFH admitted between July 2020 and February 2021 were selected as the research objects, and 20 patients (20 hips) met the selection criteria and were included in the study. The patients were divided into two groups (n=10) by central random method. The iliac bone flap was fixed with a new biodegradable magnesium internal fixation screw in the trial group, and the iliac bone flap was wedged directly in the control group. There was no significant difference (P>0.05) in gender, age, and side, type, Association Research Circulation Osseous (ARCO) stage, and disease duration of ONFH between the two groups. The operation time and intraoperative blood loss of the two groups were recorded. Laboratory tests were performed at each time point before and after operation, including white blood cell (WBC), electrolytes (K, Ca, P, Mg), blood urea nitrogen (BUN), serum creatinine (Scr), glomerular filtration rate (eGFR), lymphocyte ratio (CD4/CD8), immunoglobulin G (IgG), IgM, alanine transaminase (ALT), aspartate aminotransferase (AST). After operation, Harris score was used to evaluate the hip joint function. CT of the hip joint and X-ray films in anteroposterior and frog positions of the pelvis were used to review the iliac bone flap position, fusion, and screw biodegradation in the trial group. Results  The vital signs of the two groups were stable, the incisions healed by first intention, and no adverse events occurred after operation. One patient in the control group refused to return to the hospital for follow-up at 3 months after operation, and 1 patient in the trial group refused to return to the hospital for follow-up at 1 year after operation. The rest of the patients completed the follow-up at 2 weeks, 3 months, 6 months, and 1 year after operation. Laboratory tests showed that there was no significant difference in WBC, electrolytes (K, Ca, P, Mg), BUN, Scr, eGFR, CD4/CD8, IgG, IgM, ALT, and AST between the two groups at each time point before and after operation (P>0.05). The operation time and intraoperative blood loss of the trial group were significantly less than those of the control group (P<0.05). The Harris scores of the two groups at 1 year significantly increased when compared with the values before operation and at 6 months after operation (P<0.05). There was no significant difference in Harris score between the two groups at each time point (P>0.05). Postoperative CT of hip joint and X-ray films of pelvis showed that the iliac bone flap reached osseous fusion with the fenestration of the head and neck junction of femoral head in the two groups at 1 year after operation, and no loosening or shedding of iliac bone flap was observed during follow-up. In the trial group, there were signs of dissolution and absorption of the new biodegradable magnesium internal fixation screws after operation, and the diameter of the screws gradually decreased (P<0.05); no screw breakage or detachment occurred during follow-up. Conclusion  In the treatment of ONFH with vascularized iliac bone flap grafting, the new biodegradable magnesium internal fixation screws can fix the iliac bone flap firmly. Compared with the traditional iliac bone flap wedging directly, it has a shorter operation time, less intraoperative blood loss, and can obtain similar joint function.

Citation： CHENG Qi, SHAN Changmeng, PU Luqiao, XU Yongqing. Clinical study of a new biodegradable magnesium internal fixation screw in treatment of osteonecrosis of the femoral head. Chinese Journal of Reparative and Reconstructive Surgery, 2022, 36(11): 1343-1350. doi: 10.7507/1002-1892.202206055 Copy