Biomaterials Decision Guide - Synthes

Syn hesHow to Use this Guide? Definition.How to Use this Guide?Current pageParameters for apositive answerQuestion on bonedefect conditionsand propertiesParameters for anegative answer1. Read the question on bone defect conditions and properties on the topof the page.AWhat are the mechanicalconditions l ke?What are the mechanicalconditions like?A122. Answer the question on bone defect conditions and propertiesby considering positive (left page, green) and negative (right page, red)parameters.AThe mechanical conditions arefavourab e, ifThe fractu e is tableStable ost osynthes s is p esentThe fractu e site s n n upper limbThe bone tructure a d density are normalThe pat ent pliant(i e avoids mechanical overload ng)AThe mechanical cond tions areless favourable, ifT Stable osteosynthes un s cannot be achievedAn articula f acture s presentComminution is presenThe pat en suffers from osteopo os sThe fractu e is t bleThe fractu e site s n a lower l mbThe osteosyn hesis has worked loose or has f acturedBABCD34563. If your answer is positive: go to the bottom of the left page and followthe directory leading to the next question.If your answer is negative: go to the bottom of the right page and followthe directory leading to the next question.ABCD7894. Having answered the last question (How are the geometry and anatomyof the bone void characterised?), go to the register of solutions/products(numerical outer register).Coming from A Coming from AGo to A Go to BEFG1011This register contains a choice of products, that might be appropriateto fill the specific bone defect.ASynthesDe i ion gu de or bone vo d i le s in traumaAH12Current pageRoute to current pageRoute to next question,if positive parameters(left page, green colour)or negative parameters(right page, red colour)preponderateInner registerfor questionsNumerical outer registerfor solutions/productsStartSynthesDecision guide for bone void fiillers in traumaSynthes

AWhat are the mechanicalconditions like?What are the mechanicalconditions like?AAThe mechanical conditions arefavourable, if– The fracture is stable– Stable osteosynthesis is present– The fracture site is in an upper limb– The bone structure and density are normal– The patient is compliant(i.e. avoids mechanical overloading)AThe mechanical conditions areless favourable, if– Stable osteosynthesis cannot be achieved– An articular fracture is present– Comminution is present– The patient suffers from osteoporosis– The fracture is unstable– The fracture site is in a lower limb– The osteosynthesis has worked loose or has fracturedComing fromA Coming fromAAGo to Go toBASynthesDecision guide for bone void fiillers in traumaSynthesA

What are the mechanicalconditions like?What are the mechanicalconditions like?BBThe mechanical conditions arefavourable, if– The fracture is stable– Stable osteosynthesis is present– The fracture site is in an upper limb– The bone structure and density are normal– The patient is compliant(i.e. avoids mechanical overloading)BThe mechanical conditions areless favourable, if– A stable osteosynthesis cannot be achieved– An articular fracture is present– Comminution is present– The patient suffers from osteoporosis– The fracture is unstable– The fracture site is in a lower limb– The osteosynthesis has worked loose or has fracturedBComing fromBComing fromBCGo to Go toDB SynthesDecision guide for bone void fiillers in traumaSynthesB

What are the histopathologicalconditions like?What are the histopathologicalconditions like?AAThe histological conditions arefavourable, ifAThe histological conditions areless favourable, ifA– The bone structure and density are normal– A benign tumour is present– A dystrophy is presentComing fromAAComing fromAAAGo to Go toBASynthesDecision guide for bone void fiillers in traumaSynthesA

What are the histopathologicalconditions like?What are the histopathologicalconditions like?BBThe histological conditions arefavourable, ifBThe histological conditions areless favourable, if– The bone structure and density are normal– A benign tumour is present– A dystrophy is presentBComing fromABComing fromABGo toCGo toDBSynthesDecision guide for bone void fiillers in traumaSynthesB

What are the histopathologicalconditions like?What are the histopathologicalconditions like?CCThe histological conditions arefavourable, if– The bone structure and density are normalCThe histological conditions areless favourable, if– A benign tumour is present– A dystrophy is presentCComing fromBCComing fromBCGo toEGo toFCSynthesDecision guide for bone void fiillers in traumaSynthesC

What are the histopathologicalconditions like?What are the histopathologicalconditions like?DThe histological conditions arefavourable, if– The bone structure and density are normalDThe histological conditions areless favourable, if– A benign tumour is present– A dystrophy is presentDDComing fromBDComing fromBDGo toGGo toHDSynthesDecision guide for bone void fiillers in traumaSynthesD

How are the geometry and anatomyof the bone void characterised?AThe ratio of the bone defect volumeto the volume of the segment containingthe bone defect is averageGo to 1AThe ratio of the bone defect volumeto the volume of the segment containingthe bone defect is highGo to 1AThe bone void is irregular in shapeGo to 2Minimally invasive access is essentialGo to 2Coming fromA A AASynthesDecision guide for bone void fiillers in traumaSynthesA

How are the geometry and anatomyof the bone void characterised?BThe ratio of the bone defect volumeto the volume of the segment containingthe bone defect is averageGo to 4The ratio of the bone defect volumeto the volume of the segment containingthe bone defect is highGo to 5BThe bone void is irregular in shapeBGo to 3Minimally invasive access is essentialGo to 3Coming fromA A BBSynthesDecision guide for bone void fiillers in traumaSynthesB

How are the geometry and anatomyof the bone void characterised?CThe ratio of the bone defect volumeto the volume of the segment containingthe bone defect is averageGo to 6The ratio of the bone defect volumeto the volume of the segment containingthe bone defect is highGo to 7CThe bone void is irregular in shapeGo to 8CMinimally invasive access is essentialGo to 8Coming fromA B CCSynthesDecision guide for bone void fiillers in traumaSynthesC

How are the geometry and anatomyof the bone void characterised?DThe ratio of the bone defect volumeto the volume of the segment containingthe bone defect is averageGo to 9The ratio of the bone defect volumeto the volume of the segment containingthe bone defect is highGo to 10The bone void is irregular in shapeDGo to 9Minimally invasive access is essentialDGo to 9Coming fromA B DDSynthesDecision guide for bone void fiillers in traumaSynthesD

How are the geometry and anatomyof the bone void characterised?EThe ratio of the bone defect volumeto the volume of the segment containingthe bone defect is averageGo to 11The ratio of the bone defect volumeto the volume of the segment containingthe bone defect is highGo to 11The bone void is irregular in shapeGo to 9EMinimally invasive access is essentialGo to 9EComing fromB C EESynthesDecision guide for bone void fiillers in traumaSynthesE

How are the geometry and anatomyof the bone void characterised?FThe ratio of the bone defect volumeto the volume of the segment containingthe bone defect is averageGo to 5The ratio of the bone defect volumeto the volume of the segment containingthe bone defect is highGo to 10The bone void is irregular in shapeGo to 9Minimally invasive access is essentialFGo to 9FComing fromB C FFSynthesDecision guide for bone void fiillers in traumaSynthesF

How are the geometry and anatomyof the bone void characterised?GThe ratio of the bone defect volumeto the volume of the segment containingthe bone defect is averageGo to 9The ratio of the bone defect volumeto the volume of the segment containingthe bone defect is highGo to 10The bone void is irregular in shapeGo to 9Minimally invasive access is essentialGo to 9GComing fromB D GGGSynthesDecision guide for bone void fiillers in traumaSynthesG

How are the geometry and anatomyof the bone void characterised?HThe ratio of the bone defect volumeto the volume of the segment containingthe bone defect is averageGo to 12The ratio of the bone defect volumeto the volume of the segment containingthe bone defect is highGo to 10The bone void is irregular in shapeGo to 12Minimally invasive access is essentialGo to 9HComing fromB D HHSynthesDecision guide for bone void fiillers in traumaSynthesHH

chronOS Granules andchronOS Preforms1Product descriptionchronOS is a fully synthetic andresorbable bone graft substituteconsisting of pure b-tricalcium phosphate(b-TCP). It features a compressivestrength similar to that ofcancellous bone. chronOS has a totalporosity of 60% for the granulesand 70% for the preformed shapes.chronOS benefits from the highestpossible degree of porosity, withoutcompromising the mechanical integrity.The interconnected porousstructure of chronOS acts as an osteoconductivematrix for the ingrowthof bone cells and blood vessels.chronOS implants are resorbed andcompletely remodelled into hostbone typically within 6 to 18 months,depending on patient condition.Features and benefitschronOS is synthetic– Bone harvesting from the ileumis unnecessary, avoiding morbidityassociated with the additionalsurgery.– A patented and standardized productionprocess provides chronOSwith a constant and reliablequality and biomechanical stability.chronOS is osteoconductive– Standardised macroporosityprovides an optimal structure forbone integration.– Correct pore size allows thematerial to be colonised by bloodvessels and bone tissue.– Interconnected pores allow rapidingrowth of bone to the core ofchronOS.Characterisation ofbone defectThe patient generally is in goodcondition, does not suffer from osteoporosisand is compliant. The softtissues are largely intact, the bonedefect is contained to a large extentand the vascular supply is ample.The mechanical conditions arestable. The bone defect is critical tolarge in size. In very large bonedefects, a combination of chronOSwith bone marrow might be considered.IndicationschronOS implants can be usedas fillers in critical size bone defectsrequiring cancellous rather thancortical bone. This includes the fillingof defects of traumatic origin suchas those occurring in metaphysealfractures, reconstructions afterremoval of benign tumours or cystsand corrections, as well as aftera high tibia wedge osteotomy.chronOS is resorbable– Microporosity increases the specificsurface area and acceleratesthe remodelling process.– Correct ratio between calciumand phosphorus makes chronOScompletely resorbable.– chronOS is completely substitutedby vital bone within 6 to 18months.chronOS is versatile– The vast range of products, rangingfrom granules in 4 sizes, toblocks, straight and semicircularwedges and cylinders allow forperfect defect filling in irregular aswell as in defined bone defects.SynthesDecision guide for bone void fiillers in traumaSynthes1

2chronOS Inject2Product descriptionchronOS Inject is a synthetic calciumphosphate bone substitute. The materialis injectable, osteoconductive,and resorbable. Irregular bone defectscan be completely filled with chronOSInject using a minimally invasivetechnique. chronOS Inject hardenswithout an exothermic reaction.It also sets in a humid environment.The implant is biphasic in its hardenedstate and consists of a brushitematrix and b-tricalcium phosphate(b-TCP) granules. The brushite matrixdissolves in the interface betweenthe implant and bone (osteoid), thuspermitting the ingrowth of newbone. The spherical b-TCP granulesresorb more slowly than the brushitematrix and act as an anchor for newbone.Features and benefits– Synthetic origin: no donor sitemorbidity, reduced blood loss, lessexposure, reduced OP time– Osteoconductive: fast osteointegration– Resorbable: remodels into nativebone– Injectable: minimally invasive applicationpossible, smaller incisions,less pain, faster recovery, completevoid filling– Self-setting at body temperature:no tissue damage, less pain, fasterrecovery– Easy mixing and application: fasterand better defect fillingCharacterisation ofbone defectThe patient generally is in goodhealth, does not suffer from osteoporosisand is compliant. The softtissues are largely intact, the bonedefect is contained to a large extentand the vascular supply is ample.The mechanical conditions are stable.The bone defect is critical to large insize but rather difficult to accessand irregular in shape. A minimallyinvasive procedure is recommendedso as not to extend the incisiondue to poor accessibility of the defect.Indications– Treatment of metaphyseal bonedefects in long bones, e. g. inthe radius, tibia, calcaneus, femur,humerus etc. in the non-osteoporoticpatient.– Filling of bone or resection defectsafter osteotomy or bone harvesting– Filling of bone voids after the removalof benign cysts and tumoursand filling of post-traumatic bonedefectsIn the first phase of resorption, thebrushite matrix dissolves in the areaof the osteoid and, in a subsequentphase, the b-TCP granules arecompletely transformed into bonematrix, usually within 6 to 18 months.All components of chronOS Injectare completely synthetic. The manufacturingprocess guarantees a controlled,consistent, and reproducibleimplant quality.SynthesDecision guide for bone void fiillers in traumaSynthes

Norian SRS3Characterisation ofbone defectThe patient generally is in goodhealth, but suffers from osteoporosis.The soft tissues are largely intact,the bone defect is contained to a largeextent and the vascular supply isample. The mechanical conditions arestable, but profit if supported by amechanically stable bone substitute(early load bearing). The bone defectis critical to large in size but ratherdifficult to access and irregular inshape. A minimally invasive procedureis recommended so as not to extendthe incision due to poor accessibilityof the defect.IndicationsFilling of critical size bone voids indefect fractures of: distal radius,proximal and distal tibia, calcaneus,proximal and distal femur, proximalhumerus, acetabulum etc.Product descriptionNorian SRS (Skeletal Repair System)is an injectable, mouldable andbiocompatible calcium phosphatethat sets at body temperature intocarbonated apatite. It has a compressivestrength of approximately50 MPa, which is significantly higherthan the average 5–15 MPa ofcancellous bone. This allows for earlyload bearing. Norian SRS closelyresembles the mineral phase of boneand gradually remodels to newbone via a cellular process.Features and benefits– High compressive strength:allows early return to function– Injectable: allows minimallyinvasive surgery, optimal fill– Not exothermic: preserves bloodsupply– Remodels gradually over time:restores anatomical form andfunction3SynthesDecision guide for bone void fiillers in traumaSynthes

chronOS Granules and PreformsDBX*4Characterisation ofbone defectThe patient generally is in good healthand compliant, but suffers fromosteoporosis or/and has a weak softtissue cover. The bone defectis contained to a large extent andthe vascular supply is sufficient.The mechanical conditions are stable.The bone defect is critical in size.IndicationschronOS implants can be usedas fillers in critical-size cancellousbone defects of traumatic origin, inreconstructions and corrections.Product descriptionchronOS is a fully synthetic andresorbable bone graft substituteconsisting of pure b-tricalcium phosphate(b-TCP). It features a compressivestrength similar to that ofcancellous bone. chronOS benefitsfrom the highest possible degree ofporosity, without compromising themechanical integrity. The interconnectedporous structure of chronOSacts as a matrix for the ingrowthof bone cells and blood vessels.chronOS implants are resorbed andcompletely remo-delled into hostbone typically within 6 to 18 months,depending on patient condition.Features and benefitschronOS is synthetic: no additionalmorbidity due to bone graft harvesting;constant and reliable qualityand mechanical stability.chronOS is osteoconductive:standardised macroporosity and adefined pore size for prompt boneapposition and integration.chronOS is resorbable: the microporosityaccelerates the remodellingprocess; phase-pure b-TCP makeschronOS completely remodellablewithin 6 to 18 months.Characterisation ofbone defectThe patient generally is in good healthand compliant, but suffers fromsevere osteoporosis or/and has a veryweak soft tissue cover. The bonedefect is contained to a large extentand the vascular supply is sufficient.The mechanical conditions are stable.IndicationsDBX is used in cases where fast andreliable bone healing in critical-sizedefects is desired. Typical indicationsare the treatment of defects inseverely porotic bone or with insufficientsoft tissue cover.Product descriptionDBX is an allogenic bone substitute,consisting of demineralised bonematrix sourced from bones of humandonors. The main characteristicof DBX is its osteoinductivity: DBXactively supports new bone growth,regeneration and remodelling intonew bone within four to ten months.The donor tissue is supplied by MTF,one of the world’s largest non-profittissue banks, guaranteeing safetyand reliability. DBX is available asa mouldable putty formulation, a mixwith bone chips, and a shapeablestrip. All versions are ready-to-useallowing time-saving application.Features and benefits– Osteoinductive for fast and reliablebone fusion.– The sodium hyaluronate carrieris fully biocompatible, resistsirrigation, does not stick to glovesand makes DBX easily mouldable.– ISO certification and AmericanAssociation of Tissue Banksaccreditation guarantee highestsafety standards– Storage possible at room temperature.4* Legal manufacturer of DBX is MTF (Musculoskeletal Transplant Foundation).DBX is facilitated through Synthes.SynthesDecision guide for bone void fiillers in traumaSynthes

chronOS Granules and Preforms withBone Marrow AspirationDBX*5Characterisation ofbone defectThe general health of the patientmight be impaired (e. g. smoker,non-union, previous surgery but thedefect can be stabilised sufficiently.The histologic conditions are not optimale. g. due to an existing tumouror a dystrophy. To fill the defect witha purely osteoconductive bonesubstitute bears an increased risk offailure. Either an osteoinductive bonevoid filler or a conductive materialenhanced with osteogenetic bonemarrow are recommended. chronOSenhanced with bone marrow is idealfor situations where there is easyaccess and no complex defect shape.IndicationsThe chronOS Perfusion concept isindicated to impregnate chronOSwith bone marrow, allowing for acceleratedand enhanced remodellingof the bone graft substitute.Product descriptionchronOS Preforms are availablepre-packaged in a special perfusiondevice allowing thorough impregnationwith blood or bone marrow.The Bone Marrow Aspiration Systemcompletes the chronOS PerfusionConcept.Features and benefits– Autologous bone marrow:accelerated and enhanced osteo-integration– Vacuum perfusion system: efficientimpregnation of chronOSwith bone marrow– Marrow aspiration technique:time- and cost-saving– Synthetic origin of chronOS:reliable and reproducible productqualityCharacterisation ofbone defectThe general health of the patient isimpaired (e. g. smoker, non-union,previous surgery, severe osteoporosis)but the defect can be stabilisedsufficiently. The histologic conditionsare not optimal e. g. due to an existingtumour or a dystrophy. To fill thedefect with a purely osteoconductivebone substitute bears an increasedrisk of failure. Either an osteo-inductivebone void filler or a conductivematerial enhanced with osteogeneticbone marrow are re-commended.Defects with a complex shape or adifficult access can easily be filledwith DBX.IndicationsDBX is used in cases where fasthealing is desired in critical-size bonedefects. Typical indications are thetreatment of non-unions and poorlyvascularised defects.Product descriptionDBX is an allogenic bone substitute,consisting of demineralised bonematrix sourced from bones of humandonors. The main characteristicof DBX is its osteoinductivity: DBXactively supports new bone growth,regeneration and remodelling intonew bone within four to ten months.The donor tissue is supplied by MTF,one of the world’s largest non-profittissue banks, guaranteeing safetyand reliability.DBX is available as a mouldableputty, a mix with bone chips, anda shapeable strip. All versions areready-to-use allowing time-savingapplication.Features and benefits– Osteoinductive for fast and reliablebone fusion.– The sodium hyaluronate carrieris fully biocompatible, resists irrigationand does not stick to gloves.– ISO certification and AmericanAssociation of Tissue Banksaccreditation guarantee highestsafety standards– Storage possible at room temperature.5* Legal manufacturer of DBX is MTF (Musculoskeletal Transplant Foundation).DBX is facilitated through Synthes.SynthesDecision guide for bone void fiillers in traumaSynthes

chronOS Granules and PreformsNorian SRS6Characterisation ofbone defectThe patient generally is in good healthand compliant, but suffers fromosteoporosis or/and has a weak softtissue cover. The bone defect iscontained to a large extent and thevascular supply is sufficient. Themechanical conditions are partiallydifficult (e. g. comminution, articularfracture etc.), but can be stabilisedsufficiently. The bone defect is criticalin size.IndicationschronOS implants can be usedas fillers in critical-size cancellousbone defects of traumatic origin, inreconstructions and corrections.Product descriptionchronOS is a fully synthetic and resorbablebone graft substituteconsisting of pure b-tricalcium phosphate(b-TCP). It features a compressivestrength similar to that ofcancellous bone. chronOS benefitsfrom the highest possible degreeof porosity, without compromisingthe mechanical integrity. Theinterconnected porous structure ofchronOS acts a matrix for the ingrowthof bone cells and blood vessels.chronOS implants are resorbedand completely remodelled into hostbone typically within 6 to 18 months,depending on patient condition.Features and benefitschronOS is synthetic: no additionalmorbidity due to bone graft harvesting;constant and reliable quality andmechanical stability.chronOS is osteoconductive:standardised macroporosity anda defined pore size for prompt boneapposition and integrationchronOS is resorbable: microporosityaccelerates the remodelling process;phase-pure b-TCP makes chronOScompletely remodellable within 6 to18 months.Characterisation ofbone defectThe patient generally is in goodhealth, but suffers from osteoporosis.The soft tissues are largely intact,the bone defect is contained to alarge extent and the vascular supplyis ample. The mechanical conditionsare unstable. The bone defect is criticalin size.IndicationsFilling of critical size bone voids indefect fractures of: distal radius,proximal and distal tibia, calcaneus,proximal and distal femur, proximalhumerus, acetabulum etc.Product descriptionNorian SRS (Skeletal Repair System)is an injectable, mouldable andbiocompatible calcium phosphatethat sets at body temperature intocarbonated apatite. It has a compressivestrength of approximately50 MPa, which is significantlyhigher than the average 5–15 MPaof cancellous bone. This allowsfor early load bearing. Norian SRSclosely resembles the mineral phaseof bone and gradually remodelsto bone via a cellular process.Features and benefits– High compressive strength:allows early return to function– Injectable: allows minimallyinvasive surgery, optimal fill– Not exothermic: preserves bloodsupply– Remodels gradually over time:restores anatomical form andfunction6SynthesDecision guide for bone void fiillers in traumaSynthes

chronOS Granules and Preforms withBone Marrow AspirationNorian SRS7Characterisation ofbone defectThe patient generally is in good healthand compliant, but suffers froma mechanically challenging situation.The bone defect is extensive butcontained to a large extent and thevascular supply is sufficient. Themechanical conditions are difficult(e. g. comminution, articular fracture,difficulties to achieve an RIF etc.),but can be stabilised sufficiently.IndicationsThe chronOS Perfusion conceptis indicated to impregnate chronOSwith bone marrow, allowing foraccelerated and enhanced remodellingof the bone graft substitute.Product descriptionchronOS preforms are availablepre-packaged in a special perfusiondevice allowing thorough impregnationwith blood or bone marrow.A Bone Marrow Aspiration Systemcompletes the chronOS PerfusionConcept.Features and benefits– Autologous bone marrow:accelerated and enhanced osteointegration– Vacuum perfusion system: efficientimpregnation of chronOSwith bone marrow– Marrow aspiration technique:time and cost-saving– Synthetic origin of chronOS:reliable and reproducible productqualityCharacterisation ofbone defectThe patient generally is in good healthand compliant, but suffers fromosteoporosis or a mechanically challengingsituation. The bone defectis extensive but contained to a largeextent and the vascular supply issufficient. The mechanical conditionsare difficult (e. g. comminution, articularfracture, difficulties to achievean RIF etc.), but can be stabilisedsufficiently. To reduce the additionalmorbidity through the surgery, aminimally invasive access is desirable.IndicationsFilling of critical size bone voids indefect fractures of: distal radius,proximal and distal tibia, calcaneus,proximal and distal femur, proximalhumerus, acetabulum etc.Product descriptionNorian SRS (Skeletal Repair System)is an injectable, mouldable andbiocompatible calcium phosphatethat sets at body temperature intocarbonated apatite. It has a compressivestrength of approximately50 MPa, which is significantlyhigher than the average 5–15 MPaof cancellous bone. This allowsfor early load bearing. Norian SRSclosely resembles the mineral phaseof bone and gradually remodels tobone via a cellular process.Features and benefits– High compressive strength:allows early return to function– Injectable: allows minimallyinvasive surgery, optimal fill– Not exothermic: preserves bloodsupply– Remodels gradually over time:restores anatomical form andfunction7SynthesDecision guide for bone void fiillers in traumaSynthes

chronOS InjectNorian SRS8Characterisation ofbone defectThe patient generally is in goodhealth, does not suffer from osteoporosisand is compliant. The softtissues are intact, the bone defect iscontained and the vascular supplyis ample. The mechanical conditionsare challenging because the defectis in a lower limb metaphysis witha potential communication to thejoint.The bone defect is critical to largein size and rather difficult to accessand irregular in shape. A minimallyinvasive procedure is recommendedso as not to extend the incisiondue to poor accessibility of the defect.Indications– Treatment of metaphyseal bonedefects in long bones, e. g. in theradius, tibia, calcaneus, femur etc.in the non-osteoporotic patient.– Filling of bone voids after theremoval of benign cysts and tumoursand filling of post-traumaticbone defectsProduct descriptionchronOS Inject is a synthetic calciumphosphate bone substitute. Thematerial is injectable, osteoconductive,and resorbable. Irregular bone defectscan be completely filled, usinga minimally invasive technique.The implant is biphasic in its hardenedstate and consists of a brushitematrix and b-tricalcium phosphate(b-TCP) granules. The brushitematrix dissolves in the interfacebetween the implant and bone, thuspermitting the ingrowth of newbone. The b-TCP granules resorbmore slowly and act as an anchorfor new bone. chronOS Inject typicallyremodels into new bone within6 to 18 months. All components ofchronOS Inject are completelysynthetic.Features and benefits– Synthetic origin: no donor sitemorbidity, reduced blood loss,exposure and OP time– Osteoconductive: fast osteo -integration– Resorbable: remodels into nativebone– Injectable: for minimally invasiveapplication, smaller incisions,less pain, faster recovery– Self-setting at body temperature:no tissue damageCharacterisation ofbone defectThe patient generally is in goodhealth, but suffers from osteoporosis.The soft tissues are largely intact, thebone defect is contained to a largeextent and the vascular supply isample. The mechanical conditionsare challenging because the bonedefect is in a lower limb metaphysis,is comminuted or with implication ofthe joint. The mechanically weaksituation would profit if supportedby a mechanically stable bone substitute(early load bearing). The bonedefect is critical to large in size andrather difficult to access and irregularin shape. A minimally invasiveprocedure is recommended so asnot to extend the incision dueto poor accessibility of the defect.IndicationsFilling of critical size bone voidsin metaphyseal defect fracturessuch as: distal radius, proximal tibia,calcaneus, proximal humerus, etc.Product descriptionNorian SRS is an injectable, mouldableand biocompatible calciumphosphate that sets at body temperatureinto carbonated apatite. It hasa compressive strength of approximately50 MPa, which is significantlyhigher than the average 5–15 MPaof cancellous bone. This allowsfor early load bearing. Norian SRSclosely resembles the mineral phaseof bone and gradually remodels tobone via cellular remodelling process.Features and benefits– High compressive strength:Allows early return to function– Injectable: allows minimallyinvasive surgery, optimal fill– Not exothermic: Preserves bloodsupply– Remodels gradually over time:Restores anatomical form andfunction8SynthesDecision guide for bone void fiillers in traumaSynthes

DBX*Reamer/Irrigator/Aspirator (RIA)IndicationsDBX is used in cases where fast andreliable bone healing is desired incritical-size bone defects. Typicalin-dications are the treatment ofdefects in severely porotic bone orwith insufficient soft tissue cover.IndicationsRIA is designed to harvest finelymorselised autologous bone for anysurgical procedure requiring bonegraft. It is indicated mainly, wherelarge quantities of bone have to bereplaced.9Characterisation of bone defectThree different bone defect characteristicsindicate the use of DBX:1) The defect is enclosed and bloodsupply is sufficient but the patientis osteoporotic or suffers froma comminuted or articular fractureor there is a benign tumour.The defect is of irregular shapeor requires a minimally invasiveapproach.2) The patient’s general conditionis impaired (e. g. smoker, previousirradiation, pseudarthrosis etc.),but the mechanical conditionis stable. The defect is of irregularshape or requires a minimallyinvasive approach.3) The patient’s general conditionis impaired and the mechanicalcondition is challenging (e. g.osteoporosis, articular fracture,difficulties to achieve an RIF etc.).The defect is of irregular shapeor requires a minimally invasiveapproach.Product descriptionDBX is an allogenic bone substitute,consisting of demineralised bonematrix sourced from bones of humandonors. The main characteristicof DBX is its osteoinductivity: DBXinduces bone growth and remodelsinto new bone within four to tenmonths.DBX is available as a mouldableputty, a mix with bone chips, anda mouldable strip. All versions areready-to-use allowing time-savingapplication.Features and benefits– Osteoinductive for fast and reliablebone fusion.– The sodium hyaluronate carrieris fully biocompatible, resists irrigationand does not stick to gloves.– MTF, the supplier of bone, isISO certified and AATB (AmericanAssociation of Tissue Banks)accredited– Storage possible at room temperature.Characterisation ofbone defectTwo different bone defect characteristicsindicate the use of RIA:1) The defect is large but enclosed,blood supply is sufficient andthe bone is not porotic. The patientsuffers from a comminutedor articular fracture or there is abenign tumour. The defect is ofirregular shape or requires a minimallyinvasive approach.2) The patient’s general condition isimpaired (e. g. smoker, previousirradiation, pseudarthrosis etc.).The mechanical condition is potentiallychallenging (e. g. articularfracture, difficulties to achieve anRIF etc.). The defect is large andof irregular shape.Product descriptionReaming of the intramedullary canalcreates finely morselised bone. Thesebone chips, together with bonemarrow, are aspirated and collectedin a filter mesh by size filtration.Features and benefits– High contents of growth factors:osteoinductive for acceleratedbone ingrowth– Rich in progenitor and stem cells:osteogenetic for accelerated boneremodelling– Autologous bone: full biologicalcompatibility– Standard incision for placementof IM nails: low morbidity, low pain– Large harvesting volume of RIAaspirate: 30–80 ml9* Legal manufacturer of DBX is MTF (Musculoskeletal Transplant Foundation).DBX is facilitated through Synthes.SynthesDecision guide for bone void fiillers in traumaSynthes

DBX* mixed with chronOS GranulesReamer/Irrigator/Aspirator (RIA) togetherwith chronOS Granules10Characterisation ofbone defectThe patient’s general condition is impaired(e. g. smoker, previous irradiation,pseudarthrosis etc.). The defectsite is poorly vascularised and themechanical condition might be challenging(e. g. osteoporosis, articularfracture, difficulties to achieve an RIFetc.). The defect is large and thereforerequires a significant amount ofbone substitute (> 20 ml).IndicationsDBX, together with chronOS Granules,is used in cases where large bonedefects require fast bone healing.Typical indications are the treatmentof non-unions and large, poorlyvascularised defects.Product descriptionDBX is an allogenic bone substitute,consisting of demineralised bonematrix, sourced from bones of humandonors. The main characteristicof DBX is its osteoinductivity: DBXinduces bone growth and remodelsinto new bone within four to tenmonths. The DBX mouldable puttycan be mixed with osteoconductivechronOS Granules. The combinationprovides both, an osteoconductiveand osteoinductive solution, therebyenhancing the performance ofchronOS.Features and benefits– Osteoinductive for fast and reliablebone fusion.– The sodium hyaluronate carrier isfully biocompatible– DBX resists irrigation and doesnot stick to gloves– Combination provides improvedhandling characteristics– MTF, the supplier of bone, isISO certified and AATB (AmericanAssociation of Tissue Banks)accredited– Storage possible at room temperature.Characterisation ofbone defectThe patient’s general condition is impaired(e. g. smoker, previous irradiation,pseudarthrosis etc.). The defectsite is poorly vascularised and themechanical condition might bechallenging (e. g. articular fracture,difficulties to achieve an RIF etc.).The defect is very large and thereforerequires a significant amount ofbone substitute (> 40 ml).IndicationsRIA is designed to harvest finelymorselized autologous bone for anysurgical procedure requiring bonegraft. It is indicated mainly, wherelarge quantities of bone have to bereplaced. RIA aspirate can be mixedwith chronOS Granules. This significantlyincreases the volume andprovides it with structure, withoutcompromising its osteoinductiveand osteogenetic properties.Product descriptionReaming of the intramedullary canalcreates finely morselised bone.These bone chips, together withbone marrow, are aspirated from thecanal, collected in a filter mesh andsubsequently mixed with chronOSGranules.Features and benefits– High contents of growth factors:osteoinductive for acceleratedbone ingrowth– Rich in progenitor and stem cells:osteogenetic for accelerated boneremodelling– From the patient’s own bonetogether with chronOS: high biologicalcompatibility– Standard incision for placementof IM nails: low morbidity, low pain– Large harvesting volume of RIAaspirate together with chronOSGranules: > 40 ml10* Legal manufacturer of DBX is MTF (Musculoskeletal Transplant Foundation).DBX is facilitated through Synthes.SynthesDecision guide for bone void fiillers in traumaSynthes

chronOS Granules and Preforms withBone Marrow AspirationFeatures and benefits– Enhanced osteointegrationBecker et al. (2006) have shownthat the combination of chronOSwith autologous bone marrowclearly accelerates and enhancesosteointegration.11Characterisation ofbone defectThe patient’s general condition isnot good (e. g. smoker, previousirradiation, pseudarthrosis, poorblood supply etc.). The bone defectmight be extensive but contained.Bone density is normal and a goodstabilization of the fracture can beachieved.IndicationsThe chronOS Perfusion concept isdesigned to impregnate chronOS withbone marrow for critical-size defectsor if faster remodelling of the bonegraft substitute is required. The BoneMarrow Aspiration System is indicatedfor aspirating bone marrow.chronOS implants can be used asbone void fillers in defects requiringcancellous rather than cortical bone.Bone defects of traumatic origincan be filled, and reconstructions andorthopaedic interventions performed.Product descriptionThe use of the Perfusion Conceptallows chronOS to be combined withosteoprogenitor cells and growthfactors present in autologous bonemarrow. It enhances the biologicalproperties of chronOS and leads toaccelerated and enhanced osteointegration.Due to the highly porousstructure of chronOS, perfusion undervacuum and pressure is requiredto force the air out of the poresand bring the bone marrow into theimplant. chronOS preforms areavailable pre-packaged in specialperfusion devices allowing thoroughimpregnation. A Bone MarrowAspiration System with biopsy needlesof 11 or 15 cm length completes thechronOS Perfusion Concept.– Efficient impregnationThe specially developed perfusiondevices allow easy, effective andtime-saving intraoperative vacuumimpregnation of all chronOSperforms. According to their size,chronOS Cylinders, Blocks andWedges are pre-packaged in oneof four different perfusion devices.– Avoid bone harvestingAutologous bone graft harvestingis associated with donor site painand other morbidities. Dependingon the harvesting site and thequantity, more than 30% of allpatients suffer from donor sitepain 2 years after discharge (McKay,2002). Furthermore, bone harvestingcan be limited by insufficientvolume or quality available.The chronOS Perfusion Concept isan ideal alternative to autologousbone. It avoids donor site morbidityand shortens the duration of theoverall surgery. Having a syntheticorigin, chronOS Perfusion Conceptoffers the advantage of uniformquality and unlimited availability.11SynthesDecision guide for bone void fiillers in traumaSynthes

DBX*Reamer/Irrigator/Aspirator (RIA)Characterisation ofbone defectA worst case situation: the patient’sgeneral condition is not good(e. g. smoker, previous irradiation,pseudarthrosis etc.), and themechanical condition is challenging(e. g. osteoporosis, comminution,articular fracture, difficulties to achievean RIF etc.). The blood supply atthe fracture site is poor and there maybe dystrophy. The defect is largeand of irregular shape.IndicationsDBX is used in cases where fast andreliable healing is desired in criticalsizedefects.Typical indications arethe treatment of defects in severelyporotic bone or with insufficientsoft tissue cover and blood supply.Product descriptionDBX is an allogenic bone substitute,consisting of demineralised bonematrix sourced from bones of humandonors. The main characteristicof DBX is its osteoinductivity: DBXactively supports new bone growthand remodelling into new bonewithin four to ten months. The donortissue is supplied by MTF, one ofthe world’s largest non-profit tissuebanks,guaranteeing safety and reliability.DBX is available as a mouldableputty, a mix with bone chips, anda shapeable strip. All versions areready-to-use allowing time-savingapplication.Features and benefits– Osteoinductive for fast and reliablebone fusion.– The sodium hyaluronate carrieris fully biocompatible, resists irrigationand does not stick to gloves.– ISO certification and AmericanAssociation of Tissue Banksaccreditation guarantee highestsafety standards– Storage possible at room temperature.Characterisation ofbone defectA worst case situation: the patient’sgeneral condition is not good(e. g. smoker, previous irradiation,pseudarthrosis etc.) and the mechanicalcondition is challenging (e. g.comminution, articular fracture,difficulties to achieve an RIF etc.).The blood supply at the fracture siteis rather poor and there mightbe dystrophy. The defect is very large(> 30 ml) and of irregular shape.IndicationsThe RIA is designed to harvest finelymorselised autologous bone forany surgical procedure requiring bonegraft. It is indicated mainly, wherelarge quantities of bone have to bereplaced.Product descriptionReaming of the intramedullary canalcreates finely morselised bone. Thesebone chips, together with bonemarrow, are aspirated and collectedin a filter mesh by size filtration.Features and benefits– High contents of growth factors:osteoinductive for acceleratedbone ingrowth– Rich in progenitor and stem cells:osteogenetic for accelerated boneremodelling– Autologous bone: full biologicalcompatibility– Standard incision for placement ofIM nails: low morbidity, low pain– Large harvesting volume of RIAaspirate: 30–80 ml12* Legal manufacturer of DBX is MTF (Musculoskeletal Transplant Foundation).DBX is facilitated through Synthes.SynthesDecision guide for bone void fiillers in traumaSynthes12

Clinical consultant:Dr. Philippe CheliusClinique de ChampagneTroyes, France035.000.055 SE_150473 AA 70070042 © 09/2008 Synthes, Inc. or its affiliates All rights reserved Synthes is a trademark of Synthes, Inc. or its affiliates