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.

The Effects of Novel Pulsed Electromagnetic Field Therapy Device on Acute Distal Radius Fractures: A Prospective, Double-Blind, Sham-Controlled, Randomized Pilot Study.

BACKGROUND: this pilot study aimed at determining whether the application of a novel new method of generating pulsed electromagnetic field (PEMF), the Fracture Healing Patch (FHP), accelerates the healing of acute distal radius fractures (DRF) when compared to a sham treatment. METHODS: 41 patients with DRFs treated with cast immobilization were included. Patients were allocated to a PEMF group (n = 20) or a control (sham) group (n = 21). All patients were assessed with regard to functional and radiological outcomes (X-rays and CT scans) at 2, 4, 6 and 12 weeks. RESULTS: fractures treated with active PEMF demonstrated significantly higher extent of union at 4 weeks as assessed by CT (76% vs. 58%, p = 0.02). SF12 mean physical score was significantly higher in PEMF treated group (47 vs. 36, p = 0.005). Time to cast removal was significantly shorter in PEMF treated patients, 33 ± 5.9 days in PEMF vs. 39.8 ± 7.4 days in sham group (p = 0.002). CONCLUSION: early addition of PEMF treatment may accelerate bone healing which could lead to a shorter cast immobilization, thus allowing an earlier return to daily life activities and work. There were no complications related to the PEMF device (FHP).

An early cost analysis of magnetic bone growth stimulation in England.

BACKGROUND: Fracture nonunions impact on morbidity and health care costs and are associated with substantial pain, reduced mobility, prolonged morbidity, and a lower quality of life. CMF OrthoLogic 1000 (OL1000) is a bone growth stimulator used to promote fracture healing potentially reducing the need for surgical intervention. A cost analysis comparing CMF OL1000 versus surgical care for patients with nonunion tibial fractures was conducted. METHODS: A Markov model was developed to compare the difference in costs between CMF OL1000 versus surgical care within the English National Health Service over a 2-year time horizon. The effectiveness of CMF OL1000 was based on recently published registry data. Cost data were derived from published sources and national cost databases. Sensitivity and scenario analyses were conducted. RESULTS: The use of CMF OL1000 is estimated to lead to cost-savings of £1,104 per patient, a reduction in average healing time of 2.1 months and a relative risk of infection of 0.19 compared to immediate surgical intervention (standard of care). The results of the model are robust to most changes in input parameters and scenarios considered. CONCLUSIONS: This early analysis shows cost-savings for CMF OL1000 compared with surgical intervention for individuals with nonunion tibial fractures.