26 Oct Low-Intensity Ultrasound Not Effective In Accelerating Healing of Tibial Fractures
MedicalResearch.com Interview with:
Jason Busse
Jason Busse PhD
Associate Professor, Department of Anesthesia
McMaster University
Hamilton, ON
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Our group previously reviewed the evidence regarding the effectiveness of low-intensity pulsed ultrasound (LIPUS) for fracture healing. We found moderate to very low quality evidence for LIPUS in accelerating functional recovery among patients with fracture, and that most trials only explored effects on surrogate outcomes (e.g. radiographic healing); only five of 13 trials directly assessed functional end points – of these, one was positive. We concluded that large trials of high methodological quality, focusing on patient important outcomes such as quality of life and return to function, were needed to establish the role of LIPUS in fracture healing.
We have now completed such a study. Our large, international trial of LIPUS for surgically managed tibial fractures found the addition of LIPUS does not improve functional recovery or accelerate radiographic healing.
MedicalResearch.com: What should readers take away from your report?
Response: Low-intensity pulsed ultrasound (LIPUS) is not effective for accelerating healing of surgically managed tibial fractures.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Trials of interventions for fracture healing should focus on patient-important outcomes (e.g. function, pain, quality of life) instead of surrogate outcomes (e.g. radiographic healing, bone mineral density). Many medical devices are approved for sale without published, high-quality evidence of patient benefit. This needs to change, and ideally evidence to support medical devices will be from trials led by investigators other than those who will gain financially from clinical use of the device.
MedicalResearch.com: Is there anything else you would like to add?
Response: Negative trials can be difficult to publish. Investigators embarking on industry-funded trials require legal agreements that protect their right to publish regardless of the results. Unfortunately, our recent work on this issue has found publication agreements with industry that constrain academic authors’ independence are common [1].
.Kasenda B, von Elm E, You JJ, Blümle A, Tomonaga Y, Saccilotto R, Amstutz A, Bengough T, Meerpohl JJ, Stegert M, Olu KK, Tikkinen KA, Neumann I, Carrasco-Labra A, Faulhaber M, Mulla SM, Mertz D, Akl EA, Bassler D, Busse JW, Ferreira-González I, Lamontagne F, Nordmann A, Gloy V, Raatz H, Moja L, Ebrahim S, Schandelmaier S, Sun X, Vandvik PO, Johnston BC, Walter MA, Burnand B, Schwenkglenks M, Hemkens LG, Bucher HC, Guyatt GH, Briel M. Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials. PLoS Med. 2016 Jun 28;13(6):e1002046.
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Citation:
BMJ 2016; 355 doi: http://dx.doi.org/10.1136/bmj.i5652 (Published 25 October 2016)Cite this as: BMJ 2016;355:i5652
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Last Updated on October 26, 2016 by Marie Benz MD FAAD