Title:Lowintensityultrasound(LIUS)Treatmentforaccelerationofbonefracture Healing Exogentm

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)