Piper Danielle, Qatawneh Ayman A, Grazette Andrew, Fawdington Ross, Fenton Paul, Cooper Julian
Queen Elizabeth Hospital Birmingham, Trauma and Orthopaedic Surgery Birmingham, UK.
The Hashemite University, Faculty of Medicine Zarqa, Jordan.
Injury. 2025 Apr;56(4):112265. doi: 10.1016/j.injury.2025.112265. Epub 2025 Mar 13.
The Retrograde Femoral Nailing Advanced (RFNA) system is a new generation of retrograde femoral nail (RFN) introduced to extend the range of distal fractures treated by intramedullary (IM) nailing. There is concern that the rate of distal interlock screw back-out may be higher for the RFNA. This study aims to highlight a higher-than-expected incidence of distal locking screw migration.
Patient and implant data were prospectively collected from theatre and electronic patient records. The study focused on monitoring the migration of distal locking screws, treating each screw as an "at-risk" unit for analysis.
We report a high rate of distal locking screw migration in the Depuy-Synthes RFNA, with 16 (8.1 %) of screws migrating out of the 197 distal locking screws implanted. Per patient screw migration was seen in 11 (16.9 %) of the 65 patients studied. Oblique screws had a higher backing out rate of 13.7 % (10 out of 73) compared to the 4.8 % (6 out of 124) rate for transverse screws.
We found a higher-than-expected rate of screw migration in this new generation nail. The oblique screws were more often affected. We hypothesize that the screw orientation alongside the new polymer inlay contributes to this effect. The use of an end cap and the locking attachment washer (LAW) seems to reduce the rate of migration. The study highlights the importance of a local metalwork governance process in identifying unexpected adverse implant events. We recommend that early user centers prospectively monitor new trauma implants.
逆行股骨钉高级版（RFNA）系统是新一代逆行股骨钉（RFN），旨在扩大髓内钉治疗的远端骨折范围。有人担心RFNA的远端交锁螺钉退出率可能更高。本研究旨在突出远端锁定螺钉迁移发生率高于预期的情况。
前瞻性地从手术室和电子病历中收集患者和植入物数据。该研究重点监测远端锁定螺钉的迁移情况，将每颗螺钉作为一个“风险”单元进行分析。
我们报告了Depuy-Synthes RFNA中远端锁定螺钉的高迁移率，在植入的197颗远端锁定螺钉中有16颗（8.1%）发生迁移。在研究的65例患者中，11例（16.9%）出现了每例患者的螺钉迁移情况。与横向螺钉4.8%（124颗中有6颗）的退出率相比，斜向螺钉的退出率更高，为13.7%（73颗中有10颗）。
我们发现这种新一代髓内钉的螺钉迁移率高于预期。斜向螺钉更常受到影响。我们推测螺钉方向与新型聚合物嵌体共同导致了这种效应。使用端帽和锁定附件垫圈（LAW）似乎可以降低迁移率。该研究突出了局部金属制品管理流程在识别意外不良植入事件中的重要性。我们建议早期使用中心对新型创伤植入物进行前瞻性监测。
