overview brochure - synthes.vo.llnwd.net
TRANSCRIPT
This publication is not intended for distribution in the USA.
Overview Brochure
AccuracyEfficiency Patient Benefit
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OVERVIEW
TRUMATCH® CMF SOLUTIONSDeliver advanced technology and procedural support for facial reconstruction, orthognathic surgery, distraction and cranial reconstruction.
SURGICAL GUIDES
ORTHOGNATHIC SPLINTS
ANATOMIC MODELS
TRUMATCH® CMF SOLUTIONS
PERSONALIZED PLATES AND IMPLANTS
VIRTUAL SURGICAL PLANNING
CRANIAL RECON
DISTRACTION OSTEOGENESIS
ORTHOGNATHIC SURGERY
MANDIBLE AND MIDFACE RECON
Our total solution seamlessly integrates virtual surgical planning, intraoperative patient-specific tools and personalized implants to help achieve your goals of:
1. Ayoub N, Ghassemi A, Rana M, et al. Evaluation of computer-assisted mandibular reconstruction with vascularized iliac crest bone graft compared to conventional surgery: a randomized prospective clinical trial. Trials. 2014;15:114.
2. Hsu SS-P, Gateno J, Bell RB, Hirsch DL, Markiewicz MR, Teichfraeber JF, Zhou X, Xia JJ. Accuracy of a Computer-Aided Surgical Simulation Protocol for Orthognathic Surgery: A Prospective Multicenter Study. J Oral Maxillofac Surg. 2013; 71(1): 128–142.
3. Leiggener C, Messo E, Thor A, Zeilhofer HF, Hirsch J-M: A selective laser sintering guide for transferring a virtual plan to real time surgery in composite mandibular reconstruction with free fibula osseous flaps. Int. J. Oral Maxillofac. Surg. 2009; 38: 187–192.
4. Modabber A, Gerressen M, Stiller MB, Noroozi N, Fuglein A, Holzle F, Riediger D, Ghassemi A. Computer assisted mandibular reconstruction with vascularized iliac crest bone graft. Aesth Plast Surg 2012 Jun;36(3):653-659.
5. Rodby KA, Turin S, Jacobs RJ, Cruz JF, Hassid VJ, Kolokythas A, Antony AK. Advances in oncologic head and neck reconstruction: Systematic review and future considerations of virtual surgical planning and computer aided design/computer aided modeling. J Plast Reconstr Aesthet Surg. 2014 Sep; 67(9): 1171–1185.
6. Roser SM, Ramachandra S, Blair H, Grist W, Carlson GW, Christensen AM, Weimer KA, Steed MB. The accuracy of virtual surgical planning in free fibula mandibular reconstruction: comparison of planned and final results. J Oral Maxillofac Surg. 2010 Nov; 68(11):2824-32.
7. Saad A, Winters R, Wise MW, Dupin CL, Hilaire HS. Virtual Surgical Planning in Complex Composite Maxillofacial Reconstruction. Plast Reconstr Surg. 2013; 132(3): 626–633.
8. Xia JJ, Phillips CV, Gateno J, Teichgraeber JF, Christensen AM, Gliddon MJ, Lemoine JJ, Liebschner MAK. Cost-Effectiveness Analysis for Computer-Aided Surgical Simulation in Complex Cranio-Maxillofacial Surgery. J Oral Maxillofac Surg. 2006(64): 1780–1784.
9. Xia JJ, Shevchenko L, Gateno J, Teichgraeber JF, Taylor TD, Lasky RE, English JD, Kau CH, McGrory KR. Outcome Study of Computer-Aided Surgical Simulation in the Treatment of Patients with Craniomaxillofacial Deformities. J Oral Maxillofac Surg. 2011(69): 2014–2024.
10. Zanotti B, Zingaretti N, Verlicchi A, Robiony M, Alfieri A, Parodi PC. Cranioplasty: Review of Materials. J Craniofac Surg. 2016;27(8):2061-207211. Zhang WB, Yu Y, Wang Y, et al. Improving the accuracy of mandibular reconstruction with vascularized iliac crest flap: Role of computer-assisted techniques.
J Craniomaxillofac Surg. 2016;44(11):1819-1827.
Accuracythrough visualization of anatomy and identification of surgical challenges within a 3D planning environment, intraoperative patient-specific tools to accurately transfer the plan to the OR, and personalized implants
Efficiencythrough virtual surgical planning assisted by experienced clinical engineers to optimize preparation, surgical time and the number of procedural steps
Patient Benefitby striving to achieve satisfying aesthetic results and minimizing operative time 1–11
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TITANIUM 3D MILLED PLATE FOR MANDIBLE
The design of the TRUMATCH® CMF Titanium 3D Milled Plates for Mandible is individually engineered to meet the needs of each patient and surgeon. By selecting plate design features, surgeons can customize the reconstruction plate to create a patient-specific solution. The Plates are 3D-milled to the planned patient anatomy, eliminating the step for intraoperative adaption and creating a stronger plate* with a lower overall profile.
The plates are never bent, consequently there is no induced stress due to bending.
INTENDED USE
Patient-Specific Plates for Mandible are intended for oral, maxillofacial surgery.
INDICATIONS
Trauma and Reconstructive surgery.
3D-milled for the patient
PERSONALIZED PLATES AND IMPLANTS Features and Benefits
Derived from Patient CT Data
• Design fits the planned outcome for easy positioning of the grafts at the planned location
• Integration with virtual surgical plan ning service** for seamless transfer of the surgical plan into the OR, using patient-specific surgical guides** with built-in drill guides that align with the plate holes (optional)
Customizable Design Features
• Screw hole positions and angulations defined indivi du ally to avoid screw interference with nerves, tooth roots, osteotomies, existing or future implants
• Screw length prediction and pre- visualization of screw trajectories to ensure a collision free construct
• Compatible with MatrixMANDIBLE Condylar Head Add-on
Strength with Low Profile
• 2.0 mm and 2.5 mm plate thicknesses for improved fatigue strength* with lower profiles compared to standard reconstruction plates
* Fatigue testing data shows increased fatigue life of both 2.0 and 2.5 mm profiles in comparison with MatrixMANDIBLE 2.5 mm thick plates. Test data does not indicate clinical performance. Test data on f le at DePuy Synthes - MT12-261: Dynamic Testing of Patient-Specific Mandible Plates (PSMP), 0000073412
** Manufactured by Materialise and distributed by DePuy Synthes
Surgical Guide
Max. 15°
8.0 mm
2.5 mm2.0 mm
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Features and Benefits
• Better anatomic fit versus conventional fixation/ reconstruction methods 1,2*
• Reduced operating time compared to traditional reconstruction methods that require extensive contouring 1,2*
• Satisfying aesthetic results for surgeon and patient 1,2*
• Suitable materials for definitive treatment
• Any necessary modifications of a PEEK implant (e.g. drainage, monitoring devices) can be performed in the OR with standard instruments
• Implant fixation with DePuy Synthes plates and screw systems
• Short turnaround time
PEEK (Polyetheretherketone)
• Engineered for strength, and stability
• Radiolucent (minimal MRI artifact)
• Bone-like stiffness and strength
• Surgeon can determine plate and screw placement during surgery
• Lightweight
• Autoclavable
Other Services Offered
• One-to-one online design sessions for preoperative surgical planning
• Online surgeon accounts
• 3D tools for implant reviews
• Supply of 3D data (format STL)
1 Jalbert F, Boetto S, Nadon F, Lauwers F, Schmidt E, Lopez R. One-step primary reconstruction for complex craniofacial resection with PEEK custom-made implants. J. Cranio-Maxillofacial Surg. 2014;42:141–148.
2 Zanotti B, Zingaretti N, Verlicchi A, Robiony M, Alfieri A, Parodi PC. Cranioplasty: Review of Materials. J Craniofac Surg. 2016;27(8):2061-2072.* Results from case studies are not predictive of results in other cases. Results in other cases may vary.
• Better anatomic fit versus conventional fixation/reconstruction methods 1,2,*
• Implant fixation with DePuy Synthes plates and screw systems
• Suitable material for definitive treatment
INDICATIONS
Intended for replacement of bony voids in the cranial/craniofacial skeleton.
PERSONALIZED PLATES AND IMPLANTS
PEEK MILLED IMPLANTSDerived from CT data for satisfying reconstructive results 1,2,*
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Features and Benefits
Patient-Specific Plate Design
The location of screws and drilling vectors are defined in the planned position. Surgical access, bone volume and the avoidance of anatomical obstacles such as nerves and tooth roots are considered.
Retro Planning
Predetermined screw locations in the planned position are transposed back to the initial position.
Osteotomy and Drill Guide Design
Planned osteotomies, drill pilot hole locations and drilling vectors are integrated into the guide design, accurately transferring the surgical plan to the operating room.
Plate-Guide Color Coding
The guide and matching plate are color coded to help with identifying the right combination when multiple devices are used for the same surgery.
Designed for Matrix Compatibility
The plates and guides are designed and validated for compatibility with the MatrixMANDIBLE™, Matrix MIDFACE™, MatrixORTHOGNATHIC™ and MatrixNEURO™ screws and drill bits, depending on the application.
TRUMATCH CMF Titanium 3D Printed Plates and Guides is a direct and fully guided system for bone part repositioning. The system consists of patient-specific osteotomy and drill guides and patient-specific plates for the accurate transfer of the surgical plan to the operating room.
PERSONALIZED PLATES AND IMPLANTS
TITANIUM 3D PRINTED PLATES*Guided system for bone part repositioning
INDICATIONS
Intended for bone repositioning surgical operations for different indications:
• Orthognathic surgery• Trauma reconstruction (secondary osteotomy and repositioning of
the Zygoma) • Reconstruction surgery
CONTRAINDICATIONS
• Doubt on the reliability of patient’s anatomical scan, as the scan data may not guarantee that a patient’s anatomy is accurately represented,
• Mental or neurological health troubles making the patient unable to accept or to follow postoperative precautions,
• Smoking, • Bad quality or insufficient bone tissue, or blood circulation issues, • High sensibility to metallic materials, • In the presence of active or latent infections, • Pregnancy.
OrthognathicsZygoma Repositioning/ Orbital Floor Reconstruction
Midface Reconstruction
Mandible Reconstruction
TRUMATCH CMF Titanium 3D Printed Plates
TRUMATCH CMF Titanium 3D Printed Guides
* Manufactured by Materialise
Features• Porous structure
• Complex anatomical shape
• Predetermined screw locations
• No additional fixation plates needed
• Designed for energy absorption in case of impact (local plastic deformation of implant)**
Specific Design Features• Anatomical anchors & suture holes
• Drainage
• Variable thickness
• Combination of continuous andporous structures is possible
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PERSONALIZED PLATES AND IMPLANTS
TITANIUM 3D PRINTED IMPLANTS*Flexible design for every clinical situation
INDICATIONS
Intended for bone reconstruction and restoration of bone defects of: the cranium, frontal bone, orbital floor, wall and roof, maxilla, zygoma and mandibular bones. And more generally all defects caused by a trauma injury, tumor removal, and genetic diseases.
The implants can also be used for volumetric increase of facial skeletal (for example: chin, cheekbones, mandibular angles).
CONTRAINDICATIONS
• Doubt on the reliability of patient’s anatomical scan, as the scan data may not guarantee that a patient’s anatomy is accurately represented,
• Mental or neurological health troubles making the patient unable to accept or to follow postoperative precautions,
• Smoking, • Bad quality or insufficient bone tissue, or blood circulation issues, • High sensibility to metallic materials, • In the presence of active or latent infections, • Pregnancy.
Orbital Reconstruction
• Clinical applications include orbital floor, orbitalfloor and zygoma, supraorbital regions
• Compatible with the Matrix MIDFACE™ screwsand drill bits
Midface Reconstruction
• Clinical applications include zygoma, centralmidface, maxilla
• Dental implants support
• Compatible with the MatrixMIDFACE™ screwsand drill bits
Mandible Reconstruction
• Clinical applications include mandible volumetricreconstruction, graft containment
• Compatible with the MatrixMANDIBLE™ screwsand drill bits
Volumetric Increase of Facial Skeleton
• Clinical applications include chin, zygoma andmandibular angle
• Compatible with the MatrixMIDFACE™ andMatrixMANDIBLE™ screws and drill bits
Cranial Reconstruction
• Clinical applications include frontal, parietal,occipital regions
• Osteotomy guides available
• Compatible with the MatrixNEURO™ screws
* Manufactured by Materialise** Based on static tensile tests: HW-PorousiTi-14101G-verA Energy_Absorbation_Report
VIRTUAL SURGICAL PLANNING
CASE DATABASE
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PROPLAN CMF *Technology for precise and accurate surgical planning
• 2D and 3D preoperative visualization of thepatient anatomy and condition
• Virtual simulation and optimization of theskeletal osteotomies and reconstruction
• Improved communication between patientand surgery team
• Reduced surgical time¹–³**
• Making critical clinical decisions preoperatively
• Multiple cephalometric analysis options
• Soft-tissue simulation and photomapping (2Dand 3D)
• Live interactive virtual planning session with aknowledgeable clinical engineering team
• No software installation or softwareknowledge required
PROPLAN CMF
Used to perform the virtual surgical planning. It is operated mostly by the clinical engineers located at Materialise during the live interactive sessions.
PROPLAN CMF Online
Web-based module intended for: (1) Exchange information between DePuy Synthes sales representative, DePuy Synthes TRUMATCH CMF Team and Materialise.
(2) The surgeon use, allowing for case creation, data exchange, tracking and visualization of surgical plans, tools and implants.
Mandible and Midface Reconstruction
• Preoperative planning for virtual simulation ofresection, grafting and reconstruction
• Soft tissue simulation
Orthognathic Surgery
• Preoperative planning for virtual simulationof maxillary and mandibular osteotomies
• Cephalometric analysis
• Occlusion-based positioning
• Soft tissue simulation
• Photomapping
Distraction Osteogenesis
• Preoperative planning for virtual simulation ofosteotomies, positioning of DePuy Synthesdistractors and placement of footplates
Cranial Vault Reconstruction
• Preoperative planning for virtual simulation ofresection, grafting, reconstruction of bonysegments
• Soft tissue simulation
PROPLAN CMF is the virtual surgical planning platform consisting of two platforms:
* Manufactured by Materialise** Results from case studies are not predictive of results in other cases.
Results in other cases may vary.¹ Modabber A, Gerressen M, Stiller MB, Noroozi N, Füglein A, Hölzle F, Riediger D, Ghassemi A. Computer assisted mandibular reconstruction with vascularized iliac
crest bone graft. Aesth Plast Surg 2012 Jun;36(3):653-659.² Roser SM, Ramachandra S, Blair H, Grist W, Carlson GW, Christensen AM, Weimer KA, Steed MB. The accuracy of virtual surgical planning in free fibula mandibular
reconstruction: comparison of planned and final results. J Oral Maxillofac Surg. 2010 Nov; 68(11):2824-32.³ Leiggener C et al. A selective laser sintering guide for transferring a virtual plan to real time surgery in composite mandibular reconstruction with free fibula osseous
flaps. Int J Oral Maxillofac Surg (2009), doi:10.1016/j.ijom.2008.11.026.
INTRAOPERATIVE PATIENT-SPECIFIC
TOOLS
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PATIENT-SPECIFIC SURGICAL GUIDES*
Some examples include, but are not limited to:
• Mandible and midface resection and drilling guides
• Graft harvesting and drilling guides (e.g. fibula, iliac crest, scapula)
• Osteotomy and plate positioning guide for placement of distractor footplates
• Surgical guides for segment and/or graft resection and segment (re)placement in cranial vault reconstruction
• Osteotomy and drill guide for orthognathic surgery (3D printed Titanium)
• Osteotomy and drill guide for secondary osteotomy and repositioning of the Zygoma (3D printed Titanium)
Designed to assist with osteotomies and to accuratelytransfer the virtual surgical plan to the surgical site
Resection guide for midface reconstruction (polyamide)
Resection and drilling guide for mandible reconstruction (polyamide)
Osteotomy and drill guide for orthognathic surgery (3D printed Titanium)
Osteotomy and drill guide for secondary osteotomy and repositioning of the Zygoma (3D printed Titanium)
Graft harvesting and drilling guide (polyamide)
Osteotomy and foot plate positioning guide for distraction (polyamide)
Osteotomy guide for cranial vault reconstruction (polyamide)
Orientation indicator
Holes for temporary guide fixation
Irrigationports
Drill guides matching the plate’s holes position and angulation
Cutting slots designed per surgeon preference. Flange or slot design
* Manufactured by Materialise
INTRAOPERATIVE PATIENT-SPECIFIC
TOOLS
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PATIENT-SPECIFIC ORTHOGNATHIC SPLINTS* ANATOMIC MODELS*• TRUMATCH CMF orthognathic splints are patient-
specific surgical tools used to transfer the virtual plan to the OR, indicating the steps of the surgery based on the dentition (occlusal) information
• Intermediate and final occlusion splints available
• Multiple impression depth and buccal contour width available
• Various options to submit occlusion data: physical plaster models, optical scans of the plaster models or intraoral scan (no plaster model needed at all)
• Made of sterilizable clear acrylic
• Tactile representation of the anatomy or preoperative plan for surgical simulation and communication to the patient
• Facilitate communication with the surgical team and patient
• Highlighted critical anatomical structures like tooth roots and nerves
Three tooth impression depths Two widths of buccal contour Wiring holes Palatal strap for multi-piece maxilla * Manufactured by Materialise
WORKFLOW
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* The process for orthognathic surgery, distraction and cranial vault reconstruction follows a similar workflow. The process can be performed without personalized implants as well.
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VIRTUAL SURGICAL PLANNING, PLATES, GUIDES AND MODELS
• Start by logging into your PROPLAN CMF Online account or requestan account if you don’t have one (visit the Inter national section onwww.trumatchcmf.com to access the link and instructions)
• Alternatively, ask your sales consultant for support
• Create a new case, upload the patient CT Scan and fill in the preferencesfor the planning, guides, splints, models and implants
• Join the interactive virtual surgical planning session with an experiencedclinical engineer
• Validate your virtual surgical plan, then the patient-specific tools andfinally the personalized implants
• The guides, models and implants are manufactured and delivered to you
• You can now transfer the virtual plan to the patient, as you imagined it
• The same process applies for the milled and 3D printed plates
PEEK (MILLED) AND TITANIUM (3D PRINTED) IMPLANTS
• Start by filling a Request for Service and upload the CT scan
• We will design the implant according to your instructions and provide aquote; if required, an interactive design session can be done
• Approve the implant when you are satisfied and place an order; yoursales representative can help you with this
• We will manufacture the implant through milling or 3D printing,depending on the choice of implant
• The implant will be delivered to you
CT Scan patient/ Request for Service
CT Scan patient/ Request for Service
Approve plate* and guides
Manufacture
Interactive virtual planning
Design and Quote
Manufacture
Approve plan and plate* preference
Approve design and place order
Deliver plate, guides, models, splints
Delivery
Design plate* and guides
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SERVICES AND PRODUCTS
AT A GLANCE
Synthes GmbHEimattstrasse 34436 OberdorfSwitzerlandTel: +41 61 965 61 11Fax: +41 61 965 66 00www.jnjmedicaldevices.com
This publication is not intended for distribution in the USA.
All surgical techniques are available as PDF files at www.depuysynthes.com/ifu ©
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Personalized Implants
• Titanium 3D Milled Plates for Mandible
• PEEK Milled Implants
• Titanium 3D Printed Plates*
• Titanium 3D Printed Implants*
Patient-Specific Tools*
• Surgical guides
• Orthognathic splints
• Anatomic models
Virtual Surgical Planning*
• Planning kits
• Soft tissue simulation
• Photo mapping
• Outcome analysis
• STL file transfer
* Products and services manufactured by
and distributed by DePuy Synthes