VALUE ANALYSIS BRIEF:

CLINICAL AND ECONOMIC EVIDENCE FOR THE VALUE OF MATRIXRIB™ FIXATION SYSTEM FOR THE SURGICAL STABILIZATION OF RIB FRACTURESSYSTEM FOR THE SURGICAL STABILIZATION

Value Analysis Brief: Clinical and Economic Evidence for the Value of MatrixRIB™ Fixation System for the Surgical Stabilization of Rib Fractures DePuy Synthes Companies 2

Executive Summary

Unmet Need• Ribfracturesoccurin~10%of

patientsadmittedtoatraumacenterandareamarkerforsevereinjury.41

• Patientswithmultipleribfracturesoraflailchestfrequentlyrequiremechanicalventilation;mortalityratesofupto33%havebeenreportedinflailchest.13,14,35,41

• Prevalenceofchronicpainof22%anddisabilityof53%amongpatientswithribfracturesat6months.20

• Morethan30%ofpatientsrequireadditionalcareinpost-acutesettings.23

• Despitetheclinicalandeconomicimpactofribfractures,currenttreatmentprimarilyconsistsoflittlemorethansupportivetreatmentincludingpaincontrol,restandmechanicalventilation5,30,35andthemortalityandshorttermmorbidityhavenotappreciablyimprovedduringthelastfourdecades.2,35

• Availabilityofribfixationtechnologypresentsapotentialoptiontowardaneffectiveapproachtomanagingribfracture.

Clinical Evidence Supporting Surgical Fixation:• Resultsfromtworecentmeta-analyses(eachincluding>500

flailchestpatients)haveshownthatcomparedtomedicalmanagement(non-operative),surgicalfixationpatientshad:25,36

•57-69%lesslikelyriskofmortality

•55-82%lesslikelytohavepneumonia

•4.5-7.5fewerdaysofmechanicalventilation

•3.4-4.8fewerICUdays

•3.8-4.0fewerhospitaldays

• ResultsfromstudieswithMatrixRIB™FixationSystemdemonstrated:•MatrixRIBFixationSystempatientshadasignificant

reductionintotalventilatordayscomparedtothenonsurgicalgroup(4.5vs.16.0;p=0.04).16

•84%ofpatientshadnopainat16±1monthandpatientswhonolongerhadpainsaidtheirribpainwascompletelygoneat5.4±1.1weekspostdischarge.27

•TheneedforanalgesiawassignificantlyreducedafterMatrixRIBFixationSysteminpatientswithmultipleribfractures.15

•Within3monthsMatrixRIBFixationSystempatientsregained84%ForcedVitalCapacity(%FVC)and77%ForcedExpiratoryVolume(FEV1)9

•Atsixmonths,7of15patientsthatcompletedfollowuphadreturnedtowork9

•Ina16-monthsurvey,ofpatientswhowereemployed,33of36(92%)patientsreturnedtoworkatthesamejobthattheydidpreinjury.27

POTENTIAL IMPLICATIONS• Basedontheresultsfromtwometa-analysesfor every25flailchestpatientstreatedwithribfixation:25,36

• Hospitalcostsmaybereducedbyapproximately$453,375-$792,786 • ThesesavingswouldbeattributedtoreductionsinICUdays,mechanicalventilationdaysandincidence

ofpneumonia.

Value Analysis Brief: Clinical and Economic Evidence for the Value of MatrixRIB™ Fixation System for the Surgical Stabilization of Rib Fractures DePuy Synthes Companies 3

IntroductionThisvalueanalysisbriefpresentsclinicalandeconomicevidenceforthevalueofoperativemanagementofribfracturesandtheMatrixRIBFixationSystemspecifically.Althoughsomeribfracturesaretreatedwithpainmanagementgenerally,aswellasbracing,endotrachealintubationandmechanicalventilationifnecessary,somepatientscouldbenefitfromsurgicalstabilization(osteosynthesis).Potentialbenefitsofsurgicalstabilizationofribfracturesincludereduceddurationofmechanicalventilationsupport,shortenedICUstaysandhospitalization,reductioninchestinfection,andimprovedqualityoflife.6,7,9,16,25,27,36

MethodsAsearchofpeer-reviewedliteraturepublishedafter1990throughApril2014usingtheEMBASEandMedlinedatabaseswasconducted.Studiesevaluatingclinicalandeconomicoutcomesassociatedwithoperativefixationofribfractureorflailchestwereevaluated.Referencelistsofselectedstudieswerealsoreviewedforpossibleadditionalarticles.

BackgroundRibfracturesareobservedinapproximately10%ofpatientsadmittedtoatraumacenterandareamarkerforsevereinjury.41 Ribfracturescanleadtodefectsinthechestwallandsignificantpainwhichmayhinderbreathing.Thesepatientshaveanincreasedriskofdevelopingchestinfection,impairedpulmonaryfunction,sepsis,atelectasis,respiratoryfailureandotherpulmonarypathologiesaswellasprolongedhospitalizations.31,33 Asthenumberoffracturedribsincreases,apatient’sriskforundesiredoutcomesisincreasednotonlybecauseofotherseriousinjuries,butalsobecauseoftherespiratorycomplicationsthatareadirectconsequenceofthepainandimpairedcapacitytoventilate.10,18,38Ithasalsobeenshownthatelderlypatientswhosustainbluntchesttraumawithribfractureshavetwicethemortalityandthoracicmorbidityofyoungerpatientswithsimilarinjuries.11Inaddition,thecontributionofribfracturestoprolongeddisabilityandchronicpainisgreaterthantraditionallyexpected.17Theprevalenceofchronicpainanddisabilityamongpatientswithribfracturesatsixmonthshavebeenreportedas22%and53%,respectively.20

Patientswithmultipleribfracturesoraflailchest(unilateralfracturesofatleast3consecutiveribs,eachwith2ormorefractures32)frequentlyrequiremechanicalventilationandareatriskfordeath.35Flailchestoccursin5-13%ofpatientswithchestwalltrauma26andhasamortalityrateofupto33%.13,14 IntheUS,patientswithflailchestareinthehospitalanaverageof11days,predominantlyintheintensivecaresetting.23Morethan30%ofpatientsrequireadditionalcareinpost-acutesettings.23Indirectsocietalcostsresultfrominabilitytoworkorreducedworkplaceproductivity.

Unmet NeedDespitethemeasurableclinicalandeconomicimpactofribfractures,currenttreatmentofthemajorityofpatientsconsistsoflittlemorethansupportivetreatmentincludingpaincontrol,restandmechanicalventilation5,30,35andthemortalityandshorttermmorbidityofthisentityhavenotappreciablyimprovedduringthelastfourdecades.2,35

Therelativelyrecentavailabilityoffixationtechnologyspecificallytailoredtoribfixationpresentsapotentialoptiontowardamoreeffectiveapproachtomanagingribfracture.

MatrixRIB Fixation System* TheMatrixRIBFixationSystemiscomprisedof:

• Pre-contouredtitaniumalloylockinglowprofile1.5mmthickplateswith2.9mmdiameterlockingscrews

• Theplatesarepre-contouredtofittheaverageribshape,minimizingIntra-operativebending

• PlatestiffnessoftheMatrixRIBFixationSystemissimilartocadavericosteoporoticrib,allowingforflexibilityoftheribcage

• Thepre-contouredplatesarelongenoughtofixatemultipleandcomminuted/obliquefractures

• Anteriorplatingtechniquedesignedtoavoidsurgicaldisruptionofintercostalsofttissues,andintramedullarysplintsallowminimallyinvasiveprocedures

• Instrumentsthatenableribstabilizationofsub-scapularfractures

The relatively recent availability of

fixation technology specifically

tailored to rib fixation presents

a potential option toward a more

effective approach to managing rib

fracture.

Value Analysis Brief: Clinical and Economic Evidence for the Value of MatrixRIB™ Fixation System for the Surgical Stabilization of Rib Fractures DePuy Synthes Companies 4

MatrixRIB™MIPO(MinimallyInvasivePlateOsteosynthesis)-90degreescrewdriver

Clinical Effectiveness of Surgical Fixation vs. Medical (Non-operative) ManagementNumerousstudiescomparingsurgicalfixationvs.medical(non-operative)managementhavebeenreportedintheliterature.Thestudiesexaminedavarietyofclinicalendpoints,trialdesigns,andpatientpopulations.1,3,4,8,15,16,21,24,

28,30,37,38,40Thereisnodefinitiveclinicaltrialthatdelineatestheroleofsurgeryinthemanagementofpatientswithmultipleribfractures,25recentguidelinespublishedbytheNationalInstituteforHealthandClinicalExcellence(NICE)recommendsurgicalstabilizationofaflailchestbasedonconsistentevidenceofitsefficacyandlackofmajorsafetyconcerns.29Also,accordingtoguidelinesfromtheEasternAssociationfortheSurgeryofTrauma(EAST):“Surgicalfixationmaybeconsideredincasesofsevereflailchestfailingtoweanfromtheventilatororwhenthoracotomyisrequiredforotherreasons.”35Inaddition,therearetworecentlypublishedmeta-analysesthatsummarizetheclinicaleffectivenessofsurgicalfixationversusmedicalmanagement.25,36

Slobogeanetal(2013)36conductedasystematicreviewofpreviouslypublishedcomparativestudiesusingoperativeandnonoperativemanagementofflailchest.Atotalof11manuscriptswith753patientswereincluded.Leineckeetal(2013),25throughanNIH-supportedstudy,alsoconductedasystematicreviewofpreviouslypublishedcomparativestudiesusingoperativeandnonoperativemanagementofflailchest,however,3%ofpatientsintheoperativearmand7%inthenonoperativearmwerenon-flailchest.15,25Atotalof9studieswith538patientsmettheinclusioncriteria.

Themeta-analysesshowedsignificantbenefitofsurgicalfixationintermsofmortality,pneumonia,ventilatordays,ICUdays,tracheostomy,andsepticemia.25,36

Lower Risk of Mortality 57%

Lower Risk of Pneumonia 55%

Lower Risk of Tracheostomy 75%57% 55%

75%

Leinecke et al., 2013

Mor

talit

y

Pneu

mon

ia

Trac

heos

tom

y

Slobogean et al., 2013

Surgical Fixation Had*:

Lower Odds of Mortality 69%

Lower Odds of Pneumonia 82%

Lower Odds of Tracheostomy 88%Lower Odds of Septicemia

*septicemia not assessed

64%

Surgical Fixation Had:

Mortality Pooled RR: 0.43; 95% CI: 0.28-0.69

Pneumonia Pooled RR: 0.45; 95% CI: 0.29-0.67

Tracheostomy Pooled RR: 0.25; 95% CI: 0.13-0.47

Mortality OR 0.31; 95% CI: 0.20-0.48

Pneumonia OR 0.18; 95% CI: 0.11-0.32

Tracheostomy OR 0.12; 95% CI: 0.04-0.32

Septicemia OR 0.36; 95% CI: 0.19-0.71

The meta-analyses showed significant benefit of surgical fixation in terms of mortality, pneumonia, ventilator days, ICU days, tracheostomy, and septicemia.25,36

Operative Management is Associated with a Statistically Significant Reduction in Mortality, Pneumonia, Tracheostomy, and Septicemia Compared to Non-Operative management25,36

Value Analysis Brief: Clinical and Economic Evidence for the Value of MatrixRIB™ Fixation System for the Surgical Stabilization of Rib Fractures DePuy Synthes Companies 5

Sincepublicationofthemeta-analyses,additionalstudies,(Marascoetal.andDobenetal.),comparingsurgicalfixationtomedicalmanagementforthestabilizationofribfractureshavebeenpublished.16,28Resultswereconsistentwithwhatwasfoundinthemeta-analyses.Marascoetal.isdescribedbelowandDobenetal.isdescribedinstudiesevaluatingtheMatrixRIBFixationSystem.

• Marascoetal.28Aprospectiverandomizedcontrolledtrialofflailchestpatientsreceivingmechanicalventilationcomparedoperativeribfixation(n=23)tonon-operativemanagement(n=23)Ribfixationpatientshadsignificantly:

•shorterICUstay(3.08dayssaved;p=0.03)

• lessnoninvasiveventilationafterextubation(3hoursvs.50hours;p=0.01)

Studies Evaluating the MatrixRIB Fixation System

Hospital Resource Utilization• Dobenetal.16AretrospectivereviewofMatrixRIBFixationSystempatients

(n=10)matchedtohistoricalnon-operativecontrols(n=11)found:

•MatrixRIBFixationSystempatientshadareductionintotalICUstay(18daysvs.9days,p=0.37)

•TheMatrixRIBFixationSystempatientshadasignificantreductionintotalventilatordayscomparedtothenonsurgicalgroup(4.5vs.16.0;p=0.04)

•Patientswithsurgerywerepermanentlyliberatedfromtheventilatorwithinamedianof1.5days(0-8days)

Patients who underwent surgery

with MatrixRIB Fixation System had a significant

reduction in total ventilator days

compared to the non surgical group (4.5 vs. 16.0; p =0.04)16

# o

f D

ays

-4.5-3.4 -3.8

Leinecke et al., 2013 Slobogean et al., 2013

-9

-8

-7

-6

-5

-4

-3

-2

-1

0

-9

-8

-7

-6

-5

-4

-3

-2

-1

0

# o

f D

ays

Decrease in Ventilator Days

with Surgery

Decrease in ICU Days

with Surgery

Decrease in Hospital Days with Surgery

Decrease in Ventilator Days

with Surgery

Decrease in ICU Days

with Surgery

Decrease in Hospital Days with Surgery

-7.5

-4.8-4.0

Ventilator Days 95% CI: −5.54 to −3.50

ICU Days 95% CI: −6.01 to −0.80

Hospital Days 95% CI: −7.12 to −0.54

Ventilator Days 95% CI: −5.0 to −9.9

ICU Days 95% CI: −1.6 to −7.9

Hospital Days 95% CI: −0.7 to −7.4

Significantly Fewer Number of Ventilator Days, ICU Days, and Hospital Days with Operative Management Compared to Non-Operative Rib Fixation25,36

Value Analysis Brief: Clinical and Economic Evidence for the Value of MatrixRIB™ Fixation System for the Surgical Stabilization of Rib Fractures DePuy Synthes Companies 6

Long-term Pulmonary FunctionBottlangetal.conducteda6-monthprospectivecohortstudy,fundingsupportfromSynthesCMF,ofMatrixRIBFixationSystempatientsandmeasuredlong-termpulmonaryfunctionat3-(n=16)and6-months(n=15)post-surgery.9

•At3months,patientsregainedanaverage%ForcedVitalCapacity(FVC)of84%andaForcedExpiratoryVolume(FEV1)of77%

•At6months,theaverage%FVCand%FEV1was85%and79%,respectively

Patient-Centered Outcomes

Pain Majerciketal.performedalongterm(16-month)post-dischargetelephonesurveyandchartreviewofpatientstreatedwithMatrixRIBFixationSystem(n=50).Resultsshowedthat84%ofpatientshadnopainat16±1monthandpatientswhonolongerhadpainsaidtheirribpainwascompletelygoneat5.4±1.1weekspostdischarge.Ofthe16%(8patients)withpain,sixpatientsreportedthatthepainisminimalorintermittent,anddidnotinterferewithdailyactivities.27InastudyconductedbyDeMoyaetaltheauthorsfoundthattheneedforanalgesiawassignifcantlyreducedafterMatrixRIBFixationinpatientswithmultpileribfractures.15

Patient SatisfactionMajerciketal.measuredsatisfactionwithMatrixRIBFixationSystemonascaleof1to10,with1beingnotsatisfiedatall,and10beingverysatisfied,patients(n=50)ratedtheirexperiencewithMatrixRIBFixationSystemandtheresultsoftheprocedureas9.2±0.2.27Ninety-fourpercentstatedthattheywouldrecommendthesurgerytoinjuredfriends/family.27

0%

20%

40%

60%

80%

100%

10%

30%

50%

70%

90%

20%

40%

30%

Forced Vital Capacity

3 month 6 month 3 month 6 month

Forced Expiratory Volume (FEV1)

79%77%

85%84%

No Pain

84%

Minimal Pain

12%

Chronic Pain

4%

Pulmonary Function 3 and 6 Months after MatrixRIB Fixation System Surgery9

84% of Patients Treated with MatrixRIB Fixation System had No Pain at 16 ± 1 Month Post Discharge27

Value Analysis Brief: Clinical and Economic Evidence for the Value of MatrixRIB™ Fixation System for the Surgical Stabilization of Rib Fractures DePuy Synthes Companies 7

Return to WorkReturntoworkwasevaluatedintwostudieswithMatrixRIBFixationSystem.9,27 Bottlangetal.showedthatatsixmonths,7of15patientsthatcompletedfollow-uphadreturnedtowork.9Ina16-monthsurvey,Majerciketalfoundthatofthepatientswhowereemployed,33of36(92%)patientsreturnedtoworkatthesamejobthattheydidpreinjury.Meantimetogetbacktofull-timeworkwas7.9±1.0weeks.27

Quality of life InpatientswhounderwentsurgeryusingtheMatrixRIBFixationSystem,Billèetal.foundthemedianQualityofLifeandgeneralhealthscore(n=6)accordingtotheQLQ-C30were7(range6-7).7

Clinical and Economic Implications of the MatrixRIB Fixation SystemBasedontheresultsoftheLeineckeetal.andSlobogeanetal.meta-analyses,theBottlangetal.MatrixRIBFixationSystemprospectivecohortstudy,publishedICU42andnationalcostingdata22forpneumonia,andBureauofLaborStatisticsConsumerPriceIndexmedicalcareinflation,12itisprojectedthattheuseofMatrixRIBFixationSystemin25flailchestpatientscouldpotentiallyresultinacost-savingsbetween$453,375-$792,786.ThesesavingswouldbeattributedtoreductionsinICUdays,mechanicalventilatordaysandincidenceofpneumonia.

(792,786)

Slobogean et al., 2013Leinecke et al., 2013

(453,375)Overall Cost Savings Overall Cost Savings

Cost-savings per 25 Flail Chest Patients Undergoing Rib Fixation Surgery

Value Analysis Brief: Clinical and Economic Evidence for the Value of MatrixRIB™ Fixation System for the Surgical Stabilization of Rib Fractures DePuy Synthes Companies 8

Leinecke et al. Slobogean et al.

ICU Cost $(292,500) $(413,011)

non-ICU Cost $(13,982) $27,964

MV Cost $(394,055) $(656,758)

Pneumonia Cost $(73,864) $(72,056)

Cost of Surgery $106,875 $106,875

Cost of Device $214,200 $214,200

DiscussionAlthoughsomeribfracturesaretreatedwithpainmanagementandbracing,aswellasendotrachealintubationandmechanicalventilationifnecessary,somepatientscouldbenefitfromsurgicalstabilization.Twometa-analysesdemonstratedtheefficacyofsurgicalfixationinthetreatmentofribfracturesanditssuperioritytomedicalmanagement(non-operative).

InaliteraturesearchconductedbyGirsowiczetal,theninestudiesreviewedsupporttheuseofsurgicalstabilizationinthemanagementofisolatedmultiplenon-flailandpainfulribfractures.Benefitwasshownnotonlyintermsofpainandrespiratoryfunctionbutalsoinimprovedqualityoflifeandreducedsocio-professionaldisability.19

Basedontheseresults,useoftheMatrixRIBFixationSystemhasthepotentialtoleadtofewerICUdays,mechanicalventilationdays,casesofpneumonia,tracheostomies,mortality,casesofsepticemia,andlowercostcomparedtomedical(non-operative)managementofmultipleribfractures.StudiesevaluatingtheMatrixRIBFixationSystemshowedthatpatientshadasignificantreductionintotalventilatordayscomparedtoanonsurgicalgroupandthatmostpatientsregainedlong-termpulmonaryfunction3and6monthspost-surgery.16Patient-centeredoutcomes,includingpain,satisfaction,qualityoflife,andreturntowork,werefavorablewiththeMatrixRIBFixationSysteminthesecaseseries.7,9,15,27

Value Analysis Brief: Clinical and Economic Evidence for the Value of MatrixRIB™ Fixation System for the Surgical Stabilization of Rib Fractures DePuy Synthes Companies 9

Value Analysis Brief: Clinical and Economic Evidence for the Value of MatrixRIB™ Fixation System for the Surgical Stabilization of Rib Fractures DePuy Synthes Companies 10

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Value Analysis Brief: Clinical and Economic Evidence for the Value of MatrixRIB™ Fixation System for the Surgical Stabilization of Rib Fractures DePuy Synthes Companies 11

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