B Biglari

Gregory Della Rocca

Hans Goost

MC Inacio

MD Schofer

R Zura

R. Grant Steen

Robert Zura

S Bashardoust Tajali

Samir Mehta

X Roussignol

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LETTER TO THE EDITORLetter to the Editor re: Biglari et al. (2016)Robert Zura1 • Gregory Della Rocca2 • Samir Mehta3 • Hans Goost4 •R. Grant Steen1,5Received: 1 August 2016 / Published online: 29 September 2016 The Author(s) 2016. This article is published with open access at Springerlink.comWe read with interest the recent paper by Biglari et al. [1],which reports a prospective observational study of longbone nonunions treated with low intensity pulsed ultra-sound (LIPUS). Of the 61 nonunions included in the study,20 (32.8 %) were described as showing bone consolidation(‘‘successful treatment’’) following application of LIPUS.Nonunions for which LIPUS was deemed as ‘‘unsuccessfultreatment’’ had a significantly larger defect gap at the timeof LIPUS initiation, and were significantly less stable thanthose in the successfully treated group; such results are thusreflective of fracture characteristics which are contraindi-cated for LIPUS therapy [2].The authors pointedly reference the recent work by Zuraet al. [3], stating that ‘‘the recent study from Zura et al.presents a highly selected patient collective and mightresult in misleading conclusions’’. We believe this state-ment to be misleading, and would like to take this oppor-tunity to clarify the Zura et al. findings. In that study, datawere analyzed for 767 patients with chronic nonunion([1 year in duration) treated with LIPUS [3]. All patientswere drawn from a prospective patient registry required bythe US Food and Drug Administration. The registry wasopen to all patients and every patient who had completeinformation was assessed, so this population closelyreflects the clinical setting. Indeed, orthopedic registrystudies are known to be valuable for monitoring patientoutcomes in ‘real-world’ scenarios [4]. In a subgroupanalysis of 91 patients who were free of surgery in the90 days prior to LIPUS treatment, the study by Zura et al.[3] observed an 85.7 % heal rate, in sharp contrast to the32.8 % heal rate reported by Biglari et al. [1].Biglari et al. also noted the results of a randomizedcontrolled trial by Schofer et al. comparing LIPUS withsham-device treatment of chronic nonunion patients [5].Although a non-significant difference in the rate of healingbetween the study groups is cited, Biglari et al. fail todescribe that the study duration was just 16 weeks, sincethe endpoint of that study was not healing in a traditionalsense. The primary outcomes of that study were bonemineral density and gap area at the fracture site, both ofwhich were significantly improved by LIPUS versus shamtreatment [5].We note several additional issues with the study byBiglari et al.: (1) compliance with device usage was raisedas an important consideration, but compliance rates werenot reported; (2) osteitis, which would likely impair healingsubstantially, was seen in 23 % (14 of 61) of cases, and& R. Grant SteenGrant.Steen@bioventusglobal.comRobert Zurarzura@lsuhsc.eduGregory Della Roccadellaroccag@health.missouri.eduSamir MehtaSamir.Mehta@uphs.upenn.eduHans Goosthans@goost.de1 Department of Orthopaedic Surgery, Louisiana StateUniversity, New Orleans, LA, USA2 Department of Orthopaedic Surgery, University of Missouri,Columbia, MO, USA3 Department of Orthopaedic Surgery, University ofPennsylvania, Philadelphia, PA, USA4 Department of Orthopedic and Trauma Surgery, UniversityHospital Bonn, Bonn, Germany5 Bioventus LLC, 4721 Emperor Blvd., Suite 100, Durham,NC 27703, USA123Arch Orthop Trauma Surg (2016) 136:1629–1630DOI 10.1007/s00402-016-2579-5was significantly more prevalent in the ‘‘unsuccessfultreatment’’ group; (3) chronic nonunion was defined asnon-healing for [90 days after surgery, which is incon-sistent with most other definitions of nonunion [6]; and (4)bone reduction in Biglari et al. (as shown in Fig. 1) appearsto be sub-optimal. Furthermore, patients had an average of3.02 prior surgeries (18 patients had C4 surgeries) prior toLIPUS treatment. If we assume that every patient receivedsurgery at presentation, this means that the patientsreported in the study [1] had already failed an average oftwo additional surgeries, yet 32.8 % of these patientshealed with LIPUS treatment and no further surgery. Per-haps the findings of Biglari et al. should be viewed as atestament to the power of LIPUS to heal in the context ofsub-optimal surgical treatment.Open Access This article is distributed under the terms of theCreative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use,distribution, and reproduction in any medium, provided you giveappropriate credit to the original author(s) and the source, provide alink to the Creative Commons license, and indicate if changes weremade.References1. Biglari B, Yildirim TM, Swing T, Bruckner T, Danner W,Moghaddam A (2016) Failed treatment of long bone nonunionswith low intensity pulsed ultrasound. Arch Orthop Trauma Surg136:1121–11342. Roussignol X, Currey C, Duparc F, Dujardin F (2012) Indicationsand results for the Exogen ultrasound system in the management ofnon-union: a 59-case pilot study. Orthop Traumatol Surg Res.98(2):206–2133. Zura R, Della Rocca GJ, Mehta S et al (2015) Treatment of chronic([1 year) fracture nonunion: heal rate in a cohort of 767 patientstreated with low-intensity pulsed ultrasound (LIPUS). Injury46(10):2036–20414. Inacio MC, Paxton EW, Dillon MT (2016) Understandingorthopaedic registry studies: a comparison with clinical studies.J Bone Joint Surg Am 98(1):e35. Schofer MD, Block JE, Aigner J, Schmelz A (2010) Improvedhealing response in delayed unions of the tibia with low-intensitypulsed ultrasound: results of a randomized sham-controlled trial.BMC Musculoskelet Disord 11:2296. Bashardoust Tajali S, Houghton P, MacDermid JC, Grewal R(2011) Effects of low-intensity pulsed ultrasound therapy onfracture healing: a systematic review and meta-analysis. Am JPhys Med Rehabil 91(4):349–3671630 Arch Orthop Trauma Surg (2016) 136:1629–1630123

Archives of Orthopaedic and Trauma Surgery

Letter to the Editor re: Biglari et al. (2016)

https://link.springer.com/content/pdf/10.1007%2Fs00402-016-2579-5.pdf

Letter to the Editor re: Biglari et al. (2016)

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