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Electrical treatment of tibial non-union: a prospective, randomised, double-blind trial
Simonis RB, Parnell EJ, Ray PS, Peacock JL
Injury 2003 May;34(5):357-362
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: Yes; Blind therapists: Yes; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

Electrical stimulation in the treatment of bony non-union has been used in different forms for many years. However, there is still a lot of uncertainty about its efficacy. We, therefore, undertook a prospective, randomised, double-blind trial to try and determine its effect. Over a period of 5 years, 34 consecutive patients with a tibial non-union met our "criteria for inclusion". Each patient had an oblique fibular osteotomy, followed by a unilateral external fixator. They were then randomly allocated one of two machines. Group 1, the active group, received electrical stimulation from an active machine. Group 2, the dummy group, had an identical machine but without any current passing through the active coils. They were then followed up for 6 months and evaluated clinically and radiologically for bony union. Unfortunately, there was by chance, an imbalance in smoking habit between the two groups. The union rate in the subgroup that smoked was 75% (6/8) in the active group as compared to 46% (6/13) in the dummy group. The active group of non-smokers had 100% (10/10) union rate, compared to 67% (2/3) in the dummy group. Overall 24 out of the 34 patients progressed to union. Out of 18, 16 (89%) in the active group showed bony union as compared to 8/16 (50%) in the dummy. There was, thus, a statistically significant positive association between tibial union and electrical stimulation (odds ratio 8, 95% CI 1.5 to 41, p = 0.02).
With permission from Excerpta Medica Inc.

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