Title:Lowintensityultrasound(LIUS)treatmentforaccelerationofbonefracture healing–ExogenTM bonegrowthstimulator–November2001
Agency:MedicalServicesAdvisoryCommittee(MSAC) CommonwealthDepartmentofHealthandAgeing GPOBox9848CanberraACT2601Australia.
Reference: MSACApplication1030. AssessmentreportISSN1443-7120
Aim: ToassessthesafetyandeffectivenessofLIUStreatmentforaccelerationofbonefracturehealing (ExogenTM bonegrowthstimulator)andunderwhatcircumstancessuchservicesshouldbesupported withpublicfunding.
Conclusionsandresults
Safety: Theinterventionappearssafeforuseinadults,however,itshouldnotbeusedpriortoskeletalmaturation,orinpatientswithpacemakers.
Effectiveness: Theresultsoftwohighquality,randomised,placebo-controlledstudies conductedonthetreatmentofdistalradiusandtibialfractureswithLIUSare contradictory.ItisnotpossibletoconcludethatLIUSisconsistentlymore efficaciousthancurrenttreatmentoffreshfractures.Evaluationofcomparative effectivenessagainstcurrentAustraliantreatmentsoffracturenon-unionwas notpossible.
Cost-effectivenessThecost-effectivenessofLIUSinthetreatmentoffreshtibial,distalradiusand scaphoidfracturesdoesnotcomparefavourablywitha rangeofothercommon healthcareinterventions.
Recommendation
PublicfundingunderAustralianMedicarebenefitsarrangementsshouldnotbesupportedforthisservice.
Method
MSACconductedasystematicreviewofthemedicalliteraturefrom1996toOctober2000.ThisreviewsoughtdataontheuseofLIUStotreatclosedand/orgrade1openfreshfracturesandexisting fracturesexhibitingnon-union.Furtherinformationwassourcedfromtheapplicant.
Randomisedcontrolledclinicaltrialevidencewasavailablefortibial,distalradiusandscaphoidfresh fractures.Onlynon-comparativecaseseriesandregistrydatawereavailableforfracturenon-union. Evidencewasclassifiedandscoredwithrespecttostudydesign,patientcharacteristics,minimisationofbias,outcomesmeasuresandstatisticalanalyses.Theprimaryoutcomemeasurewastimetohealingdefinedasindependentradiologicalconfirmationofbridgingofthreeoffourcortices.
ValidcomparatorsweredeterminedbyareviewofcurrentAustralianpractice.
Thecomparatorfor freshfracturesofthetibia,distalradiusandscaphoidwascastimmobilisation(withorwithoutclosed reduction). Inaddition,fortibialfracturesspecifically,theuseofanintramedullaryrodwasalsoan appropriatecomparator. Thecomparatorforfracturenon-unioninthepubliclyfundedhealthsector wasopenreductionandinternalfixationwithbonegrafting.
Economicevaluationswereundertakentodeterminethecost-effectivenessandcostutilityratiosof LIUStreatmentoffreshfractures,relativetocurrentAustralianpractice. Directandindirectcosts wereconsidered. Withrespecttonon-unions,thecost-effectivenessofLIUSrelativetocurrent Australianpracticewasunabletobeinvestigatedduetothelackofcomparativeefficacydata.PreparedbyDrAdèleRWeston,MedicalTechnologyAssessmentGroup(M-TAG)