一种新型脉冲电磁场设备作为桡骨远端骨折手术治疗的辅助治疗方法：一项前瞻性、双盲、假对照、随机初步研究。

A novel pulsed electromagnetic field device as an adjunct therapy to surgical treatment of distal radius fractures: a prospective, double-blind, sham-controlled, randomized pilot study.

机构信息

Hand Surgery Unit, Division of Orthopedic Surgery, Tel Aviv Medical Center, 6423906, Tel Aviv, Israel.

Affiliated to Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

出版信息

Arch Orthop Trauma Surg. 2024 Jan;144(1):543-550. doi: 10.1007/s00402-023-05117-0. Epub 2023 Nov 16.

DOI:10.1007/s00402-023-05117-0

PMID:37971511

Abstract

INTRODUCTION

The purpose of this study is to evaluate whether using a Fracture Healing Patch (FHP) device that generates pulsed electromagnetic fields (PEMF), applied at the fracture site immediately after open reduction and internal fixation surgery, can accelerate healing of acute distal radius fractures.

METHODS

In a prospective, double-blind, randomized, and sham-controlled study, thirty-two patients with DRFs treated with ORIF were included. Patients were allocated to a PEMF (active) group (n = 15) or a control (sham) group (n = 17). All patients were assessed with regard to functional Patient-Rated Wrist Evaluation (PRWE), SF12, and radiological union outcomes (X-rays and computed tomography (CT) scans) at 2, 4, 6, and 12 weeks postoperatively.

RESULTS

Patients treated with the FHP demonstrated significantly bone bridging at 4 weeks as assessed by CT (70% vs 54%, p = 0.05). Mean grip strength in the active group was significantly higher as compared to control (16 ± 9 kg vs 7 ± 3.5 kg, respectively, p = 0. 02). The function subscale of the PRWE was significantly better in PEMF-treated group at 6 weeks after surgery (27.2 VS 35.5, p = 0.04). No statistically significant differences were found in SF12.

CONCLUSION

PEMF application after ORIF of DRFs is safe, may accelerate bone healing which could lead to an earlier return to daily life activities and work.

LEVEL OF EVIDENCE

摘要

引言

本研究旨在评估在切开复位内固定术后立即于骨折部位使用产生脉冲电磁场的骨折愈合贴（FHP）设备是否能加速急性桡骨远端骨折愈合。

方法

在一项前瞻性、双盲、随机、假对照研究中，纳入了 32 例接受切开复位内固定治疗的 DRF 患者。患者被分为 PEMF（主动）组（n=15）或对照组（假）组（n=17）。所有患者均在术后 2、4、6 和 12 周时进行了功能腕部患者报告评估（PRWE）、SF12 和影像学愈合结局（X 线和 CT 扫描）评估。

结果

CT 评估显示，使用 FHP 的患者在 4 周时具有明显的骨桥形成（70%比 54%，p=0.05）。主动组的平均握力明显高于对照组（分别为 16±9kg 比 7±3.5kg，p=0.02）。术后 6 周，PRWE 的功能子量表在 PEMF 治疗组显著更好（27.2 VS 35.5，p=0.04）。SF12 无统计学差异。