Effectiveness and safety of biodegradable Mg-Nd-Zn-Zr alloy screws for the treatment of medial malleolar fractures

Background: /Objective: This study aimed to evaluate the effectiveness and safety of treating medial malleolar fractures using our patented Mg-Nd-Zn-Zr alloy (abbr. JDBM) screws with Ca–P coating, in order to provide a solid basis for their further clinical translation. Methods: Nine patients with medial malleolar fractures were treated using coated JDBM screws. All patients had closed injuries, and none had open fractures. Postoperative radiography was performed to evaluate fracture healing and degradation of the JDBM screws. The visual analogue scale (VAS) was used to evaluate the degree of postoperative pain perceived by the patients, and the American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scoring system was used to evaluate their postoperative ankle function. Postoperative complications, including infection, failure of internal fixation, and malunion, were carefully recorded during follow-up. Results: The mean follow-up time was 12.2 ​± ​4.9 months. After the operation, all patients achieved good medial malleolar fracture alignment, and none of them experienced breakage of the JDBM screws before fracture healing. Postoperative radiography indicated JDBM screws gradually degradated with implantation time, and obvious degradation could be observed 12 months, postoperatively. At the final follow-up, the patients’ mean VAS score was 2.3 ​± ​1.9. The mean AOFAS score was 90.4 ​± ​8.9, with excellent or good rates of 88.9%. None of the patients experienced infection, failure of internal fixation, malunion, or other complications. Conclusion: Coated biodegradable JDBM screws are effective for the treatment of medial malleolar fractures, and have good prospects for further clinical translation in the future. Translational potential statement: The results of this study indicates coated biodegradable JDBM screw is an alternative internal fixation instrument for fracture treatment and has excellent prospects for clinical translation.