Sports Orthopaedics Research Foundation, 31 Old Broad Street, London, EC2N 1HT, UK.
North Middlesex University Hospital, Sterling Way, London, N18 1QX, UK.
BMC Musculoskelet Disord. 2019 Jul 19;20(1):334. doi: 10.1186/s12891-019-2717-7.
Biodegradable implants reduce the likelihood of further surgery for hardware removal and reduce the risks of associated infection and allergy. The purpose of this study is to evaluate the clinical efficacy and determine the comparability of biodegradable magnesium alloy MgYREZr (MAGNEZIX® CS) compression screw fixation compared with standard titanium screw fixation in the surgical treatment of hallux valgus deformity.
Eleven patients undergoing corrective surgery for hallux valgus utilising biodegradable magnesium screws and a control group of 25 patients undergoing corrective hallux valgus surgery with standard titanium screws were reviewed at a median of 19 months (range 12-30 months). PROM scores (Manchester-Oxford Foot Questionnaire (MOXFQ), Foot and Ankle Outcomes Instrument (FAOI) and the EQ-5D-3 L) were recorded preoperatively and at latest follow-up.
The results between the two groups were broadly similar, with the Magnesium and Titanium patients showing similar patterns in the various domains in the MOXFQ, the FAOI and the EQ-5D-3 L. Most patients reported a near full shoe comfort score, and EQ-5D-3 L scores were significantly improved in both patient groups (with most patients reporting a full score). Foot pain and foot function improved irrespective of the scoring systems and patients in both groups demonstrated significantly improved scores following the surgery (p < 0.05). Notably, there were no significant differences when comparing the post-operative scores between the groups for any individual scoring parameter. No impairment to quality of life was recorded. There were no intra or post-operative complications. There were no problems encountered through the use of the bioabsorbable screws.
Biodegradable magnesium-based compression screws appeared to be safe in this study and are an effective fixation device in the treatment of hallux valgus deformity with clinical outcomes similar to standard titanium screw fixation.
可生物降解植入物降低了因去除硬件而再次手术的可能性，并降低了相关感染和过敏的风险。本研究的目的是评估临床疗效，并确定可生物降解镁合金 MgYREZr（MAGNEZIX® CS）与标准钛螺钉固定在治疗拇外翻畸形的外科手术中的可比较性。
对 11 名接受拇外翻矫正手术的患者（采用可生物降解镁螺钉）和 25 名接受标准钛螺钉矫正拇外翻手术的患者进行了回顾性分析，平均随访时间为 19 个月（12-30 个月）。记录术前和最新随访时的 PROM 评分（曼彻斯特-牛津足部问卷（MOXFQ）、足部和踝关节结局工具（FAOI）和 EQ-5D-3L）。
两组结果基本相似，镁和钛患者在 MOXFQ、FAOI 和 EQ-5D-3L 的各个领域表现出相似的模式。大多数患者报告接近完全的鞋子舒适度评分，并且两组患者的 EQ-5D-3L 评分均显著提高（大多数患者报告全分为满分）。无论评分系统如何，足部疼痛和足部功能均得到改善，两组患者手术后评分均显著提高（p<0.05）。值得注意的是，在比较两组患者的术后评分时，任何单一评分参数均无显著差异。未记录到生活质量受损。没有出现术中或术后并发症。没有遇到使用生物可吸收螺钉的问题。
在这项研究中，可生物降解的镁基压缩螺钉似乎是安全的，并且是治疗拇外翻畸形的有效固定装置，其临床结果与标准钛螺钉固定相似。
