A double-blind trial of pulsed electromagnetic fields for delayed union of tibial fractures.

A total of 45 tibial shaft fractures, all conservatively treated and with union delayed for more than 16 but less than 32 weeks were entered in a double-blind multi-centre trial. The fractures were selected for their liability to delayed union by the presence of moderate or severe displacement, angulation or comminution or a compound lesion with moderate or severe injury to skin and soft tissues. Treatment was by plaster immobilisation in all, with active electromagnetic stimulation units in 20 patients and dummy control units in 25 patients for 12 weeks. Radiographs were assessed blindly and independently by a radiologist and an orthopaedic surgeon. Statistical analysis showed the treatment groups to be comparable except in their age distribution, but age was not found to affect the outcome and the effect of treatment was consistent for each age group. The radiologist's assessment of the active group showed radiological union in five fractures, progress to union in five but no progress to union in 10. In the control group there was union in one fracture and progress towards union in one but no progress in 23. Using Fisher's exact test, the results were very significantly in favour of the active group (p = 0.002). The orthopaedic surgeon's assessment showed union in nine fractures and absence of union in 11 fractures in the active group. There was union in three fractures and absence of union in 22 fractures in the control group. These results were also significantly in favour of the active group (p = 0.02). It was concluded that pulsed electromagnetic fields significantly influence healing in tibial fractures with delayed union.

RCT Entities:   Population Interventions Outcomes