www.elsevier.es/rmuanl
ORIGINAL
ARTICLE
Pedicle
screw
sublaminary
wiring
(PSSW)
combined
with
anti-tuberculosis
chemotherapy
for
treating
spinal
tuberculosis
in
adults:
A
cohort
study
A.
Azharuddin
a,b,
J.K.
Fajar
c,∗aDepartmentofOrthopedicandTraumatology,SchoolofMedicine,UniversityofSyiahKuala,Dr.ZainoelAbidinTeaching
Hospital,BandaAceh,Indonesia
bSpineSurgery,dr.ZainoelAbidinTeachingHospital,BandaAceh,Indonesia
cMedicalResearchUnit,SchoolofMedicine,UniversityofSyiahKuala,BandaAceh,Indonesia
Received26November2015;accepted19April2016 Availableonline11June2016
KEYWORDS Tuberculosis spondylitis; PSSW; Kyphosis; Neurological disorders
Abstract
Background: Operative procedures and anti-tuberculosis combinationsare controversial for tuberculousspondylitis(TS)managementincaseswithriskofdeformity,fragments,instability, andneurologicaldisorders.
Purpose: Toassesstheeffectivenessofacombinationofanti-tuberculosisandpediclescrew sublaminarywiring(PSSW)fortreatingTS.
Method: Thisstudywasacohortstudywithapre-test/post-testcontroldesign.Thisstudywas conductedattheDr.ZainoelAbidinHospital(BandaAceh)fromMarch2005toMarch2007. Samp-lingtechniquewasjudgementsampling.Neurologicaldatadeficit(Frankelclassification)was analyzedbeforeandaftertreatmentusingtheSpearmantest.Kyphosisangleswereanalyzed beforeandaftertreatmentusingtheregressioncorrelationtest.
Results:Atotalof18patients(61.1%maleand38.9%female)participatedinthisstudy.The spinalcolumninvolvedinthisstudywas55.6%thoracic,27.8%thoraco-lumbar,and16.7% lum-bar.Neurologicalstatusbeforethetreatmentwas11.1%FrankelC,72.2%Frankel,D,and16.7% FrankelE.Neurologicalstatusafterthetreatmentwas5.55%FrankelCand94.4%FrankelE. Itshowedthattherewasnosignificantassociationbetweenacombinationofanti-tuberculosis andPSSWforneurologicaldeficitimprovement(P=0.212).Themeanangleofkyphosisbefore
∗Correspondingauthorat:Jl.TanoehAbe,Darussalam,BandaAceh23111,Indonesia.Tel.:+62081235522287;fax:+6206517551843. E-mailaddress:[email protected](J.K.Fajar).
http://dx.doi.org/10.1016/j.rmu.2016.04.003
thetreatmentwas 23.05±11.9whileafter thetreatmentitwas10.5±5.9.Itshowedthat therewasasignificantassociationbetweenacombinationofanti-tuberculosisandPSSWfor kyphosisdegreeimprovement(P=0.000).
Conclusions:Acombinationofanti-tuberculosisandPSSWforsixmonthsprovidedsignificant resultsifassessedfromdegreeofkyphosis,butdidnotprovidesignificantresultsifassessed fromFrankelclassification.
©2016UniversidadAut´onomadeNuevoLe´on.PublishedbyMassonDoymaM´exicoS.A.Thisis anopenaccessarticleundertheCCBY-NC-NDlicense(http://creativecommons.org/licenses/ by-nc-nd/4.0/).
Introduction
Tuberculosis spondylitis (TS) is one of the oldest known humandiseases.Thisdiseasewasfirstdescribedin1779by PercivalPott,thereforethisdiseaseisalsoknownasPott’s disease.1 The average number of extra-pulmonary
tuber-culosis(TB) in the world hasremained stable.TS is most commonlymusculoskeletal TB, theprevalence ofwhich is about 40---50% of all cases of musculoskeletal TB2 and an
estimated1---2%ofallcasesofTB.3TSincidenceis1.17per
100,000infemalesand0.916per100,000inmales.4
Further-more,theincidenceofneurologicalcomplicationsofTBis about10---43%.5
TSisthemostdangerousmusculoskeletalTB.Itcancause damageduetobonedeformity,seriousmorbidity,bone dis-orders,andsevereneurologicaldeficits.6Theregionsofthe
spinethatwere mostoftenaffected byTSwere35% lum-bar, 31% thoracal, 15% thoraco-lumbar, 13% cervical, and 6%cervico-thoracal,7butthispercentagewasvariedin
sev-eralotherpublications.GargandSomvanshi8revealedthat
thethoracicregionofthevertebralcolumnwasmost fre-quently affected. Godlwana et al.4 found that the spinal
regionaffectedwas42%thoracic,30%lumbar,11%cervical, 10%thoraco-lumbar,5%lumbosacral,and2%sacral.Turgut3
found thatthe spinalregion affectedwas55.8% thoracic, 22.8%lumbar,16.9%thoracolumbar,and4.2%cervical.Kotil etal.9 found that the most common regionof Pott’s
dis-easewasthethoracolumbarjunction(41%),followedbythe thoracic(36%),andlumbar(23%)regions.
Untilnow,themanagementofTSisstillcontroversialdue tothe high variationin clinical TS. The Medical Research CounciloftheUnitedKingdom(MRC,London)suggestedthe useof an isoniazid andrifampicin regimen for sixmonths asstandard therapy forTS, butit didnotincludeTS with damagetothreeormoreareasofthespine.10 Other
stud-ies revealed that the risk of deformity, instability, and progressiveneurologicaldeficitswererelatedtothe num-berof spinal areasdamaged andindicated that operative managementshouldmaintainspinalstability.6,11Therefore,
althoughtheMRC10suggestedthatdrugtherapyisastandard
treatmentforTS,itisnotapplicabletoallcasesofTS. One of the operative procedures for TS is pedicle screwsublaminarywiring(PSSW).PSSW,besidescorrecting kyphosisdegrees,isalsoexpectedtoimproveneurological deficits.12 A study conducted by Jutte andVan
Loenhout-Rooyackers13 and Issack and Boachie-Adjei14 revealed
that surgical management could improve the degree of kyphosis.
Inthisstudy,weconductedtheobservationofkyphosis improvement after PSSW combined with anti-tuberculosis drugs,asassociatedwithneurologicalstatus.
Material
and
method
Researchdesign
This wasan observational analytical study. The design of thisstudyisacohortstudywithapretest/posttestcontrol design.
Researchscheduleandlocation
ThestudywasconductedattheOrthopaedicDepartmentof theCentreofSurgeryInstallationandtheRadiology Installa-tionattheDr.ZainoelAbidinTeachingHospital,fromMarch 2005toMarch2007.
Researchpopulationandsample
The samples in this study were TS patients who agreed toreceiveacombinationofanti-tuberculosistherapywith PSSWbasedonclinicalindications.Thesamplingtechnique usedin this studywas judgementsampling. The inclusion criteriaofthisstudywere(1)patientage>18years,(2) diag-nosedclinically,microbiologically,andradiologicallyasTS, (3)thelesion’sregionswerefoundinthethoracal, thoraco-lumbar, and/or lumbar regions. Exclusion criteria of this study were(1)patientswithotherspine disordersand(2) patientswithseveresystemicdisorders.
Researchprocedures
Table1 GenderandspineregionofTSpatients.
Criteria Amount(n) Percentage(%)
Gender
Male 11 61.1
Female 7 38.9
TSregion
Thoracal 10 55.6
Thoraco-lumbar 5 27.8
Lumbar 3 16.7
dividedintotwodosesfor sixmonths.(4)PSSWoperative procedure witha posteriorapproach(resectionofspinous processlamina,transverseprocess,ribs,resectionof pedi-cles, middle column,posterior wall,controlled closureof posterior defect, and cantilever Pedicle Screw Sublami-narWiringinstrumentation).15 (5)Afterthewoundhealed,
patientswerere-examinedaboutneurologicaldeficitsand radiologytodeterminetheangleofkyphosisaftersurgery, (6)ThedataobtainedwasprocessedusingSPSSver16.0to assessdescriptivelyandanalyticallytoaccessthe associa-tionbetweenvariables.
Researchvariables
Frankelclassification
Thismethodof classificationis usedasasystem to evalu-ateanddocumenttheneurologicalprogressofanindividual patient, a large number of patients, or a subgroup of patients with spinal injuries following a full neurological examination.16Datawasobtainedbyneurological
examina-tion,andtheordinalscalewasusedtoassessthisvariable.
Kyphosisangle
Theanglemeasuredfromlinesdrawnfromthesuperior bor-deroftheupperendvertebraandtheinferiorborderofthe lowerendvertebra,withperpendicularlinesdrawnfromthe endvertebralinestomeasuretheintersectingangle.17The
datawereobtainedbyanX-raymeasurement.Theinterval scalewasusedtoassessthisvariable.
Statisticalanalysis
Datawasanalyzed usingunivariateandbivariateanalysis. Data on neurological deficits before and after treatment was analyzed using the Spearman test. Data of kyphosis angle before andafter treatment wasanalyzed using the regressioncorrelationtest.Datawasconsideredsignificant ifP<0.05.18
Results
A totalof 18 patients participated in thisstudy. 61.1%of themweremaleand38.9%ofthemwerefemale.The aver-age ageof TS patientsin this studywas27.88 years.The spinal regionaffectedwas 55.6%thoracic, 27.8% thoraco-lumbar,and16.7%lumbar(seeTable1).
Neurological status of patients beforethe intervention was11.1% FrankleC, 72.2% Frankle D,and 16.7% Frankle
Table 2 Frankel classification before and after intervention.
No. Frankle classificationa
before intervention
Frankle classifica-tionafter intervention
Significance (P)
1 E E
0.212
2 E E
3 E E
4 D E
5 D E
6 D E
7 D E
8 D E
9 D E
10 D E
11 D E
12 D E
13 D E
14 D E
15 D E
16 D E
17 C E
18 C C
a Frankel’sclassification19:
GradeA,completelossofbothmotorandsensoryfunctions. GradeB,completemotorloss,somesensationspreserved. GradeC,motorfunctionspresent,butuseless.
GradeD,motorfunctionuseful,butweak. GradeE,neurologicallyintact.
E.Neurologicalstatusafterinterventionwas5.6%FrankleC and94.4%FrankleE(seeTable2).Anexplanationregarding isaFrankelclassification19 isdescribedinTable2.
Table2showsneurologicaldeficitsbeforeandafterthe intervention.The Spearmantestwasperformed tofindan association of neurological deficits before and after the intervention.The SpearmantestresultsobtainedP=0.212 (P>0.05),anditwasconcludedthattherewasno statisti-callysignificantassociationbetweenacombinationofPSSW andanti-tuberculosistherapyandimprovementof neurolog-icaldeficitsinpatientswithTS.
TheRegressioncorrelationtestwasperformedtoassess thedegreeofkyphosisbeforeandaftertheintervention.It obtainedP=0.000(P>0.05),soweconcludedthattherewas astatisticallysignificantassociationbetweenacombination ofPSSWandanti-tuberculosistherapywithimproveddegree ofkyphosisinTSpatients(seeTable3).
Discussion
Tuberculosisspondylitis(TS)isasecondaryinfectiondisease ofthespine.TSisthemostcommonandthemost danger-ousof TB infections. TS is a commonmusculoskeletal TB withthatmakesupnearlyhalfofallcasesof musculoskele-talTB.2TheincidenceofTShasnodifferencebetweenmale
andfemale.3ThisstudyshowedthatTSwasmorecommonin
Table3 Kyphosisanglebeforeandafterintervention.
No. Kyphosis angle before interven-tion (◦)
Kyphosis angleafter interven-tion (◦)
Significance (P)
Correlation coefficient
1 8 0
0.000 0.970
2 9 4
3 10 3
4 10 4
5 11 5
6 13 7
7 14 9
8 19 9
9 21 11
10 25 11
11 25 13
12 27 13
13 29 13
14 35 14
15 37 16
16 39 19
17 41 19
18 42 20
X±SD 23.05±11.910.5±5.9
incidenceofTSwas34.6%infemalesand65.4%inmales,20
39.5%infemalesand60.5%inmales,2154.2%infemalesand
45.8%in males,22 25%in females and75% in males,23 50%
in females and50% in males,3 48% in females and 52% in
males,966.6%infemalesand33.3%inmales,24and1.17per
100,000inthefemalepopulationand0.916per100,000in themalepopulation.4
The generally affected spinal regions are often not significantly different. A review by Garg and Somvanshi8
revealed that the thoracic region of the vertebral col-umn wasmost frequently affected. A study by Punamiya etal.7 showed that the spinal regions affected were 35%
lumbar, 31% thoracic, 15% thoraco-lumbar, 13% cervical, and6% cervico-thoracic. Godlwana etal.4 found that the
spinal regions affected were 42% thoracic, 30%lumbar, 11%cervical,10% thoraco-lumbar,5%lumbosacral,and2% sacral.Turgut3foundthatthespinalregionsaffectedwere
55.8% thoracic, 22.8% lumbar, 16.9% thoracolumbar, and 4.2% cervical. Kotil et al.9 found that the most common
region of Pott’s disease was the thoracolumbar junction (41%), followed by the thoracic (36%), and lumbar (23%) regions.Ourresultsfound thatthespinalregionsaffected werethoracic(55.6%),thoraco-lumbar(27.8%),andlumbar (16.7%).
This studyalsoreportedkyphosisanglesand neurologi-caldeficitsin patients withTS.In thisstudy,the average angleofkyphosisinTSpatientsbeforetheinterventionwas 23.05±11.9and10.5±5.9after.Kyphosisoccursduetothe destructionofthe spine.Kyphosis canbe foundin almost all TS patients who have spinal damage in the affected
region.Kyphosisoccursduetothedestructionof the cor-pus vertebrae. It is caused by infection in the anterior region.Kyphosishasagreatertendencytooccurinthe tho-racicregioncomparedtootherregions.25Furthermore,this
study foundthat FrankelD neurologicdeficitsoccurred in 83.3% ofpatients, andfound that94% ofpatients showed an improvementof neurologicalstatusafterthe interven-tion.Neurologicaldeficitscanbefoundinalmostallcasesof TS,withmanifestationssuchasparaplegia,paresis,reduced sensibility,or caudaequina syndrome.The manifestations ofneurologicaldeficitsdependsontheregionofthe dam-age.TSmanifestationsappearbetween3and4monthsafter infectionof thespine. The manifestationsappeared a lit-tle longerin the lumbar region. This is due to the spinal canalofthelumbarregionbeingwider,andthusmore tol-erant to neurological disorders, while the spinal canal of thethoracicregionisnarrow,whichresultsinneurological symptomsappearingfaster.13
Acombinationofanti-tuberculosisdrugsandPSSWresults intotalmanagementofTS.Therestorationofthepatient’s condition is this management’s goal, so that patient can return tosocial life, family,and the work environment.15
PSSW,orshorteningprocedure,ispartofthetotaltreatment approachforTS.Theshorteningprocedureisperformedby removing laminaeand facetjoints, precessustransversus, adjacent ribs, and middle segments until circumferential decompressionoftheduramaterandcordisachieved.Then, thecorrectionisperformedbyclosingtheposteriorgapwith posterior segmental instrumentation (cantilever pedicle screwsublaminarwiringinstrumentation).26Managementof
TSisdifferentineachinstance,buthasthesamebasic prin-ciples.No study hasreported acombination ofPSSW and anti-tuberculosisdrugsinpatientswithTS.However,several similarstudieshavereportedresultsthatwerenotmuch dif-ferentfromthisstudy.Zhangetal.27 conductedastudyon
surgicalmanagementformultilevelnoncontiguousthoracic spinal tuberculosis by single-stage posterior transforami-nalthoracicdebridement,limiteddecompression,interbody fusion,andposteriorinstrumentation(modifiedTTIF) com-bined with anti-tuberculosis chemotherapy for 3 months. Follow-up wasconductedat 10 monthsafter surgery.The resultsshowedimprovementinpatientswithTS.The kypho-sisangledecreasedfrom19.21±12.63to8.07±6.91.The neurologicalstatusofthe12patientswithpreoperative neu-rologicaldeficitswere6withgradeDrecoveredtonormal; 2withgradeB,bothofthemtogradeD;4withgradeC,2 togradeD,1togradeE,and1stillingradeC.Sahooetal.24
conductedastudy aboutaposterior-only approachsurgery for fixation and decompression of thoracolumbar spinal tuberculosis combined with anti-tuberculosis drugs and chemotherapyfor6monthsforthetreatmentofTS. Follow-up was observed at 24 months after surgery. The results showedthat kyphosisimproved froma preoperative value of 17.7±5.8 degreesto9.4±4.6 degreespostoperatively and neurological recovery occurred in 94.4% of patients. Maetal.28 conductedastudyabouttheoutcomesof
wasobservedat 12weeksaftersurgery.Theresultsfound that the kyphosis degree was corrected by a mean of 11.5◦ in group A and 12.6◦ in group B, respectively. Fu etal.29conductedastudyaboutacombinationofintensified
anti-tuberculosistreatment,posteriortranspedicularscrew systeminternalfixation,intertransversebonegrafting,and ananteriorapproachfocusdebridementforthetreatment ofthoracolumbartuberculosis.Follow-upwasconductedat 12---23 months after surgery. The results showed that all thepatients achievedsuccessfulbonyfusion6---18 months after operation, and the Cobb angle was 7---21 degrees (average15.2degrees)12monthsafteroperation,without aggravation.TheFrankelgradingsystemwasusedtoassess postoperative neurological function. 1 patient in grade B before the operation was improved to grade C after the operation,1 patientingrade BwasimprovedtogradeD, 1patientingradeCwasimprovedtogradeD,4patientsin gradeBwereimprovedtogradeE,and7patientsingradeD wereimprovedtogradeE.Xuetal.30conductedastudyon
theeffectsofonestagesurgicaltreatmentof thoracolum-barspinaltuberculosisbyanteriorradicaldebridementwith bone graft fusion and posterior pedicle screw-rodsystem fixationcombinedwithanti-tuberculosischemotherapyfor 9months.Thepatients wereall complicated,with kypho-sisdeformityand anaverage Cobbangle of (28.0+/−9.7) degrees(beforesurgery).According totheFrankel neuro-logicalfunctiongradesystem, therewere3casesingrade B,5 in gradeC, 1 in grade D, and 12 in grade E (before surgery).Follow upwasconducted2.5yearsaftersurgery. The results showed that the kyphosis deformity was cor-rected by 17.2 degrees in the thoracolumbar region, on average. According tothe Frankel neurological functional gradesystem,1casewasingradeC,3ingradeD,and17in gradeE(aftersurgery).Yangetal.31 conductedastudyon
the effectof one-stageanteriordebridement of infection in functionreconstructionofthe anteriorandmiddle col-umn combinedwith anti-tuberculosis chemotherapy for 9 monthsforthetreatmentofthoracolumbarspinal tubercu-losis.In 14cases withspinalcordinjury (beforesurgery), there were 5 cases of grade C and 9 cases of grade D, accordingtotheFrankelclassification.The kyphoticCobb anglewas20---65degrees(41degreesonaverage). Follow-up was conducted 12 months after surgery. The results showedthatat12monthsafteroperation,thepain disap-peared,andtherewere7casesofgradeDand7casesof gradeE,accordingtotheFrankelclassification.Thekyphotic Cobbanglewas0---33degrees(24degreesonaverage).This studyassessedradicalsurgeryandposteriorimplant place-mentcombinedwithanti-tuberculosischemotherapyforsix monthsforthetreatmentofTS.Theresultsshowedthatit waseffectiveforpatientswithTStocorrectspinal kypho-sis.
Conclusion
PSSW, combined with anti-tuberculosis chemotherapy for six months, waseffective for patients withTS to correct spinal kyphosis, but it did not show a statistically signifi-cantdifferencetoimprovetheneurologicaldeficitsalthough approximately94%ofthepatientsshowedanimprovement inneurologicalstatus.
Conflicts
of
interest
Theauthorshavenoconflictsofinteresttodeclare.
Funding
Nofinancialsupportwasprovided.
Acknowledgements
ThankstotheDirectorandstaffofDGHIE-IUJakartaand HEI-IUUniversityofSyiahKuala.ThankstoDirectorandstaffof GeneralHospitalDr.ZainoelAbidin,BandaAceh.
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