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Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_5 | Pages 13 - 13
1 May 2015
Mitchell C Timms A Laubscher M Goodier D Calder P
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Background:. The Exogen Ultrasound Device is licensed for fracture non-union under NICE guideline MTG-12. Reimbursement is offered if there is no fracture union after 250 days of treatment as per manufacturer guidelines. Quoted healing rates vary between 62% and 100%: we compare our results to these. Method:. A retrospective audit of all patients who received Exogen for long bone non-union was undertaken. The indication, duration of treatment, fracture outcome and compliance with the recommended treatment pathway were recorded. Results:. 41 patients (17M 24F) mean age 41yr were reviewed. There were 15 femoral, 22 tibial and 4 humeral non unions. 16 healed following a mean of 169 days of Exogen treatment (39%). 21 patients did not show any improvement in radiological/clinical union and required further surgery. 4 were not united after 250 days of Exogen treatment. No reimbursements were received. Discussion:. Our results with Exogen differ from published studies with lower than expected healing rates. Failure to complete the recommended pathway however resulted in a breach of the reimbursement stipulations. Conclusion:. Ongoing review of prescription and use of the Exogen device is required to ensure optimum patient outcomes. 250 days of treatment may not be required to determine failure to heal


The Bone & Joint Journal
Vol. 99-B, Issue 4 | Pages 494 - 502
1 Apr 2017
Simpson AHRW Keenan G Nayagam S Atkins RM Marsh D Clement ND

Aims

The aim of this double-blind prospective randomised controlled trial was to assess whether low intensity pulsed ultrasound (LIPUS) accelerated or enhanced the rate of bone healing in adult patients undergoing distraction osteogenesis.

Patients and Methods

A total of 62 adult patients undergoing limb lengthening or bone transport by distraction osteogenesis were randomised to treatment with either an active (n = 32) or a placebo (n = 30) ultrasound device. A standardised corticotomy was performed in the proximal tibial metaphysis and a circular Ilizarov frame was used in all patients. The rate of distraction was also standardised. The primary outcome measure was the time to removal of the frame after adjusting for the length of distraction in days/cm for both the per protocol (PP) and the intention-to-treat (ITT) groups. The assessor was blinded to the form of treatment. A secondary outcome was to identify covariates affecting the time to removal of the frame.