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.
Results There was no difference in the time to removal of the frame between the PP (difference in favour of the control group was 10.1 days/cm, 95% confidence interval (CI) -3.2 to 23.4, p = 0.054) or ITT (difference 5.0 days/cm, 95% CI -8.2 to 18.21, p = 0.226) groups. The smoking status was the only covariate which increased the time to removal of the frame (hazard ratio 0.47, 95% CI 0.22 to 0.97, p = 0.042).
Conclusion LIPUS does not influence the rate of bone healing in patients who undergo distraction osteogenesis. Smoking may influence bone healing.
Cite this article: Bone Joint J 2017;99-B:494–502.
A. H. R. W. Simpson: Primary investigator, Co-ordinator, Designed the concept, Writing the paper.
G. Keenan: Recruiting, Patient review, Data collection.
S. Nayagam: Designed the concept, Recruiting, Patient review, Data collection.
R. M. Atkins: Designed the concept, Recruiting, Patient review, Data collection.
D. Marsh: Designed the concept, Recruiting, Patient review, Data collection.
N. D. Clement: Data analysis, Writing the paper.
The authors would like to acknowledge the help of J. Ryaby in the early stages of this study.
The authors declare funding in the form of a grant received by The University of Edinburgh from Smith & Nephew for this study.
Although none of the authors has received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this article, benefits have been or will be received but will be directed solely to a research fund, foundation, educational institution, or other non- profit organization with which one or more of the authors are associated.
This article was primary edited by J. Scott.
Supplementary material. Further information pertaining to the Distraction Osteogenesis Exogen protocol is available alongside the online version of this article at www.boneandjoint.org.uk
- Received June 9, 2016.
- Accepted December 2, 2016.
- ©2017 The British Editorial Society of Bone & Joint Surgery