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.

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: I.