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Cranioplasty jc Macquarie Neurosurgery Journal Club

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MACQUARIE NEUROSURGERYJOURNAL CLUBStephen Honeybul, David Anthony Morrison, Kwok M. Ho, Christopher R. P. Lind, andElizabeth GeelhoedA randomised controlled trial comparing autologous cranioplasty with custom-made titanium cranioplastyJournal of Neurosurgery, January 2017, volume 126, pp81-90.

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AuthorsSenior author: Stephen Honeybul, neurosurgeon Sir Charles Gairdner HospitalDavid Morrison: biomedical engineer Royal Perth HospitalKwok Ho: intensive care physician Royal Perth HospitalChristopher Lind: neurosurgeon Sir Charles Gairdner Hospital and RPHElizabeth Geelhoed, professor of population health, UWA

Disclosures/FundingNo disclosures

Partially funded by Western Australian State Health Research Advisory Council ($129 500)

Doesnt mention company

Study RelevanceCranioplasty after decompressive craniectomy is performed to restore cerebral protection; for cosmesis; and has been reported to improve neurologic function Benefits of patients own bone: cheap; biocompatible; radiolucent; ideal contour.Disadvantages: high failure rate due to infection or bony resorptionTitanium is an alloplastic material that has been previously used due to strength and biocompatibilityComputer-assisted design and manufacturing has made production of custom-made plates viable

asceptic necrosis causes bone flap resorption (28 of 92 patients in one series had major resorption, range from 4 to 50% in literature)rates of infection 1-2% in W.A. 20% in some series.paper in 2013 reporting on 127 titanium cranioplasties in RPH and CGH (Neurosurgery. 2013 Feb;72(2)248-56;256. Cranioplasty with custom-made titanium plates--14 years experience. Wiggins A, Austerberry R, Morrison D, Ho KM, Honeybul S)8 references by S.H.

OriginalityFirst RCT comparing bone to titanium

52 patients, 6 months follow up. mixed results, 2 HA infections, 5 titanium; reoperation in 7 patients in each group

AimTo compare the long term aesthetic and functional outcomes, and the cost-effectiveness, of primary autologous bone versus primary prefabricated titanium cranioplasty.

Hypothesis: primary titanium cranioplasty improves cerebral protection by avoiding the frequent problem of bone resorption requiring reoperation, and this will offset the higher initial outlay cost of titanium plates

hypothesis stated in discussion

Trial DesignProspectively registered with ANZCTR (ACTRN12612000353897)Interventional randomised controlled trialSingle centre, single surgeonTwo arm, parallel group studySingle Blinded (to patient and relatives)

Initially double blinded, but changed to single blinded after failure to get funding for a research nurse. So assessment of outcome was performed by surgeon.

Trial DesignEligibility criteria:age >18decompressive craniectomy + own bone available

Exclusions:bone flap damaged or comminutedintracranial infection following craniectomypenetrating brain injury

Trial DesignManufacture:based on high resolution CTrapid protocol 3D model of skull createdplates manufactured from medical grade titanium, (thickness 0.6-1.0mm)patient identification and orientation laser marked on plateplate try-fitted on model to ensure smooth contour and unambiguous orientationstandard steam sterilisation

company?deals with hospital?

Trial DesignSurgical procedure:all cases performed by S.H.detailed operative description

one surgeon limit confounders from different techniques and expertise.introduces some bias to be discussed later

Trial DesignPrimary outcome measure:implant failure requiring reoperationeither infected cranioplasty requiring removal of implant or bone flap resorption

Secondary outcome measures:adverse events (any time in the 12 months)cosmetic and functional outcome (assessed by S.H. and patient/primary carer)total hospital costs over 1 year period

assessment of bone flap resorption performed by S.H. based on post-op CT and the 12 month CT (criteria shown later)AEs: neurologic deterioration; post-op collections; increased seizure ratefunctional assessment involved clinical palpation to assess how effectively the contour of the skull was restored

Trial DesignPrimary Outcome assessment

assessment performed by S.H.and infection was defined as infected cranioplasty requiring removal and systemic antibiotics

Trial DesignSecondary Outcome assessment

overall outcome was graded based on the lowest score achieved, i.e. to be a complete success, it needs complete success in all categories

Trial DesignStatistical Analysis Plansample size calculation: taking p

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