This publication is not intended for distribution in the USA.

Orthognathics

TRUMATCH® CMF SOLUTIONSDeliver advanced technology and procedural support for facial reconstruction, orthognathic surgery, distraction and cranial reconstruction.

Our total solution seamlessly integrates virtual surgical planning, intraoperative patient-specific tools and personalized implants to help achieve your goals of:

ACCURACY through 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

EFFICIENCY through virtual surgical planning assisted by experienced clinical engineers to optimize preparation, surgical time and the number of procedural steps

PATIENT BENEFIT by striving to achieve satisfying aesthetic results and minimizing operative time

TRUMATCH® ORTHOGNATHICSTRUMATCH Orthognathics is a guided system which helps addressing the challenge of vertical maxillary positioning in complex asymmetric cases. The combination of Titanium 3D-printed patient-specific osteotomy/drill guides and personalized plates supports:

• the accurate transfer of the surgical plan to the operating room

• reducing the need of splints and plate bending• avoiding vital anatomical structures

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OVERVIEW

SURGICAL GUIDES

ORTHOGNATHIC SPLINTS

ANATOMIC MODELS

ORTHOGNATHIC SURGERY

TRUMATCH® CMF SOLUTIONS

VIRTUAL SURGICAL PLANNING

CRANIAL RECON

DISTRACTION OSTEOGENESIS

MANDIBLE AND MIDFACE RECON

PERSONALIZED PLATES AND IMPLANTS

Single bar or Strut design

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TI 3D-PRINTED PLATESIndividually designed to meet the needs of each patient and surgeon. Together with the matching guides, they provide a total solution aiming to support:

• the accurate transfer of the virtual surgical plan to the surgical site

• reducing the need for splints and plate bending

• avoiding vital anatomical structures

BSSO Plates

Genioplasty Plates

PERSONALIZED PLATES AND IMPLANTS • Intended to be used in combination with the Ti 3D printed guides

• Screw locations and vectors defined based on surgical access, bone volume and the avoidance of anatomical obstacles (nerves, tooth roots)

• Color coded to the matching guides

• Markers to facilitate the correct placement

• 0.8 mm and 1.0 mm thick, Pure Titanium Grade 2

• Designed and validated for compatibility with MatrixORTHOGNATHIC™ and MatrixMIDFACE™ screws and drill bits

Posterior top right or left indicator

Le fort I Plates

In line hole pattern2+2 hole design

Mixed design and patterns 3+3 hole designClover leaf hole pattern

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TI 3D-PRINTED SURGICAL GUIDESDesigned to assist with osteotomies and to accurately transfer the virtual surgical plan to the surgical site.

• Intended to be used in combination with the Ti 3D printed plates

• Design integrates the planned osteotomies, pilot hole locations and drilling vectors

− Cutting slots to guide the osteotomies, designed based on surgeon’s preference

− Drilling locations and vectors defined based on surgical access, bone volume and the avoidance of anatomical obstacles (nerves, tooth roots)

• Temporary fixation holes

• Color coded to the matching plates

• Anatomical markers to facilitate correct guide placement

• Designed and validated for compatibility with MatrixORTHOGNATHIC™ and MatrixMIDFACE™ screws and drill bits

INTRAOPERATIVE PATIENT-SPECIFIC

TOOLS Le Fort I guide

Genioplasty guide

Lateral extension of 5 mm

Midline cutting slot

Short lateral extension

Open design Flat design Bridge design Closed design

Drill guides

Cutting slots

Cutting slots

Cutting slots

Mental foramen indicator

Drill guides

Drill guides

Holes for temporary guide fixation

Screw vectors and position defined to avoid anatomical obstacles

Holes for temporary guide fixation

Holes for temporary guide fixation

BSSO guide

Features Design Options

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INTRAOPERATIVE PATIENT-SPECIFIC

TOOLS

POLYAMIDE SURGICAL GUIDESDesigned to assist with osteotomies and to accurately transfer the virtual surgical plan to the surgical site

Le Fort I guides• For osteotomies

• Can be used with standard plates (e.g. MatrixORTHOGNATHIC plates)

Genioplasty guides• For osteotomies and positioning of the chin

• Can be used with standard plates (e.g. MatrixORTHOGNATHIC plates)

* Manufactured by Materialise

Cutting flanges

Holes for temporary guide fixation

Drill Guide

Cutting Guide

Repositioning Guide

Drill holes in preoperative mandible

Wide enough for chin plate

Holes match drill holes from first step

Flange to guide genioplasty cut

Splint indexes to teeth

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• 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

• Palatal strip for multi-piece maxilla

• Sandwich (splint-in-splint) design to avoid re-wiring

• 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

Three tooth impression depths Two widths of buccal contour Wiring holes Palatal strap for multi-piece maxilla

Standard design

Top component = Final splint

Bottom component removed

Top + bottom = Intermediate splint

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ORTHOGNATHIC SPLINTS/WAFERS

ANATOMIC MODELS

INTRAOPERATIVE PATIENT-SPECIFIC

TOOLS

Intermediate Final

Sandwich / Splint-in-Splint Design

• 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

VIRTUAL SURGICAL PLANNING

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PROPLAN CMF Technology for precise and accurate surgical planning

Preoperative planning for virtual simulation of maxillary and mandibular osteotomies

• 2D and 3D preoperative visualization of the patient anatomy and condition

• Virtual simulation and optimization of the skeletal osteotomies and reconstruction

• Improved communication between patient and surgery team

• Reduced surgical time¹*

• Making critical clinical decisions preoperatively

• Multiple cephalometric analysis options

• Soft-tissue simulation and photomapping (2D and 3D)

• Live interactive virtual planning session with a knowledgeable clinical engineering team

• No software installation or software knowledge required

Starting from (CB)CT patient data, the software generates 2D and 3D visualizations of the pre-operative patient anatomy. Where applicable, this can also be combined with facial pictures and scans of the dentition (optical scans of dental casts or intra-oral scan of the dentition).

Most common osteotomies

• Maxilla (single and multi-piece)

− Le Fort I

− Le Fort II

− Le Fort III

• Mandible

− BSSO

− VRO

− Genioplasty

Any other osteotomies according to surgeon preferences

* Results from case studies are not predictive of results in other cases. Results in other cases may vary. ¹ Value Brief Virtual Surgical Planning and TRUMATCH CMF Solutions, 2015

Pre-operative situation

Maxilla movement

Mandible movement

Chin movement

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VIRTUAL SURGICAL PLANNING

Cephalometric analysis

• Automatically perform cephalometric analyses

• Perform accurate 3D cephalometric analyses (e.g. Steiner, McNamara, Downs North Western, Ricketts)

Soft tissue simulation* and photo mapping

• Assessment of the effect of planned treatments on soft tissue

• Overlay of simulated planned soft tissue with pre-operative soft tissue

• Assessment of the overall appearance, by using 3D photomapping

Movement analysis

• Overall movement summary of selected points of occlusal and bony anatomical landmarks from the preoperative scan position to simulated postoperative position

* Displays a prediction of the behavior of the patient’s soft tissue after surgically modifying the facial skeleton. Although the biomechanical algorithm has been successfully validated by Materialise on real-life cases, no guarantees are given on the accuracy of the predicted outcome on specific patients or surgical routines. Interpret the results with clinical judgment.

Left/Right Ant/Post Up/Down Point (mm) (mm) (mm)

A 0.5 Left 3.0 Anterior 4.0 UpANS 0.6 Left 3.0 Anterior 4.0 UpMe 0.8 Right 13.3 Anterior 5.8 UpPog 0.6 Right 13.1 Anterior 5.9 UpMaxilla Medial L 0.6 Left 3.0 Anterior 3.7 UpMaxilla 1st Molar L 0.1 Left 3.0 Anterior 3.5 UpMaxilla Lateral R 0.6 Left 3.0 Anterior 4.7 UpMaxilla Medial R 0.6 Left 3.0 Anterior 4.3 UpMandible 1st Molar R 0.1 Left 6.3 Anterior 5.3 UpMandible Incisor Midline 0.0 6.3 Anterior 5.3 UpMandible Canine L 0.1 Left 6.3 Anterior 4.9 UpMaxilla 1st Molar R 0.1 Left 3.0 Anterior 4.5 UpMandible Canine R 0.1 Left 6.3 Anterior 5.4 UpMaxilla Lateral L 0.6 Left 3.0 Anterior 3.4 UpMaxilla Canine L 0.0 3.0 Anterior 3.6 UpMandible 1st Molar L 0.1 Left 6.3 Anterior 4.5 UpMaxilla Incisor Midline 0.0 3.0 Anterior 4.0 UpMaxilla Canine R 0.0 3.0 Anterior 4.4 Up

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WORKFLOW

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DESIGN WORKFLOW CASE WORKFLOW• Start by downloading PROPLAN CMF Connect and request a new account via the web

interface (visit www.trumatchcmf.com to access the download link and instructions)

• Alternatively, ask your sales consultant for support

• Create a new case in PROPLAN CMF Connect and upload the patient CT Scan. Fill in the preferences for the planning, guides, splints, models and implants

• Join the interactive virtual surgical planning session with an experienced clinical engineer

• Approve your virtual surgical plan, followed by the patient-specific tools and 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

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CT Scan patient/ Request for Service

Approve plate and guides

Interactive virtual planning

Manufacture

Approve plan, plates and guides preferences

Deliver plate, guides, models, splints

Design plate and guides

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PRE-OP WITH HOLES AND OSTEOTOMIES

PLANNED

GUIDE DESIGN

PRE-OP

PLATE DESIGN

FINAL SCREW POSITION

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CASE STUDY*

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PATIENT PROFILE AND PRE-OPERATIVE SITUATION

TREATMENT PLAN

A 22-year-old male patient was referred from a local orthodontist for evaluation of a combined orthodontic surgical approach for correction of a class III malocclusion.

The challenges included a frontal and lateral open bite in combination with a maxillary transversal deficiency. The patient showed a midfacial hypoplasia which resulted in concave facial profile and positive lip step. The large tongue showed lateral teeth impressions and the patient had an immature swallowing pattern.

The young patient complained about his difficulty eating and especially biting. Prior to the start of the orthodontic treatment the third molars were removed. After an intensive case discussion with the orthodontist the first idea of a rapid palatal extension prior to the bimaxillary surgery was discarded and a two-piece Le Fort I osteotomy with maxillary advancement and posterior widening in combination with a mandibular setback was planned.

The patient returned to the orthodontist to be set up for surgery.

Following the additional orthodontic leveling and aligning, the surgical plan included the following procedures:

• a two-piece Le Fort I osteotomy with maxillary advancement

• posterior maxillary widening to compensate the transversal deficiency

• posterior maxillary impaction to close the open bite and normalize the occlusal plane

• a bilateral sagittal split osteotomy with mandibular setback and autorotation.

VIRTUAL SURGICAL PLANNINGPreoperative multi-slice computer tomography (MSCT) was obtained and uploaded in PROPLAN CMF Connect. During a web-based meeting with a clinical engineer, the surgical procedures were planned.

First the skull was oriented in the natural head position in accordance to the Frankfurt horizontal plane and the bipupillary line.

Afterwards, a two-piece Le Fort I osteotomy with maxillary advancement and posterior impaction were planned . In addition the plan included a posterior maxillary widening to compensate the transversal deficiency in relation to the mandible. Then a bilateral split osteotomy with mandibular setback and autorotation was simulated to achieve the final occlusion.

As the final step, the midline, the position of the incisors, the maxillary canting and the chin position were checked in relation to the facial midline, the lips and the natural head position. Fine tuning of the position was performed by moving the mono-block out of maxilla and mandible in final occlusion.

A soft tissue simulation in the planned position of the bones was also performed, as shown below.

Pre-surgery lateral and frontal view and x-ray showing Class III malocclusion, frontal and lateral open bite

Pre-operative situation

Pre-operative soft tissue situation Soft tissue simulation in planned position

Planned osteotomies Final position

* Results from case studies are not predictive of results in other cases. Results in other cases may vary.

CASE STUDY

Guide positioning

Plate attached in accordance to the primary pre-drilled screw holes

Osteotomy in accordance to the guide

BSSO fixed using a SplitFix plate

Midline osteotomy complete

Final outcome

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IMPLANT AND GUIDE DESIGN After the final position of the maxilla was virtually determined along with the necessary osteotomies, the placement, clustering and angulation of the screws was determined taking into consideration bone availability, teeth roots and surgical access. The plates were designed based on these constraints.

Next, the osteotomized bone segments (with the associated planned screw position and osteotomies) are virtually moved back to the preoperative position. The guides could be now designed with the drilling and cutting features as virtually planned.

The plate and the guide were then produced from Pure Titanium Grade 2 using a laser melting process.

INTRAOPERATIVE SURGICAL DETAILSUnder general anesthesia via nasal endotracheal intubation, a maxillary vestibular approach was used to gain access for the two-piece Le Fort I osteotomy.

Upon maxillary exposure, the surgical guide was placed and fixed with two MatrixMIDFACE 1.5 mm screws on the maxilla. The position of the guide was determined by the precise fit of the guide which allows a unique position.

Then the screw holes were pre-drilled (black arrow) and Le Fort I osteotomy (white arrow) was performed in accordance to the surgical guide.

After removal of the guide the two-piece Le Fort I osteotomy was completed and the down fracture in combination with the midline split was performed.

Maxillary positioning in all three dimensions (sagittal, transversal and vertical) was achieved by fixing the patient specific plate in accordance to the pre-drilled screw holes at the maxilla first and at the midface second.

Additional transversal stability of the two-piece Le Fort I osteotomy was achieved by using a transversal wire enforced palatal plate which was manufactured prior to surgery by the dental technician.

The new maxillary position in sagittal, transversal and vertical dimension is encoded in the shape of the patient specific plate. No additional splint (wafer) or intraoperative measurements were necessary for positioning of the maxilla.

After closing the maxilla, a classical BSSO with semi rigid SplitFix fixation was performed and the final occlusion was adjusted using a splint (wafer) in final occlusion.

Plate design based on the planned bones and screws position

Guide design based on the planned osteotomies and final screws position

Plate and guide set ready for surgery

CASE STUDY

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RESULTS AND DISCUSSIONThe patient did well postoperatively. A stable Class I occlusion could be achieved and the open bite could be closed safely. He had full sensation along the V2 and V3 distribution of the trigeminal nerve six weeks postoperatively.

There are two main benefits of this wafer-less maxillary positioning.

The first benefit is the high precision of maxillary positioning according to the virtual plan without the loss of vertical control of the maxilla. We could achieve an accuracy between plan and result of median below 0.5 mm in all 3 axes x, y and z (in a series of 12 cases).

The second benefit is the significant reduction of surgery time of up to one hour due to the straight forward procedure, without the need of an intermediate splint/wafer, which eliminates the intraoperative plate bending and any measuring for the adjustment of the vertical dimension.

Postoperative images and x-ray showing Class I occlusion and no open bite

Surgeons Profile

PD Dr. Dr. Frank Wilde (MD, DMD) Vice Chair Oral and Plastic Maxillofacial Surgery Military Hospital Ulm Ulm, Germany

Prof. Dr. Dr. Alexander Schramm (MD, DMD) Professor and Chair Oral and Maxillofacial Surgery University Hospital Ulm Oral and Plastic Maxillofacial Surgery Military Hospital Ulm Ulm, Germany

Synthes GmbHEimattstrasse 34436 OberdorfSwitzerlandTel: +41 61 965 61 11Fax: +41 61 965 66 00www.depuysynthes.com

This publication is not intended for distribution in the USA.

All surgical techniques are available as PDF files at www.synthes.com/lit ©

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TRUMATCH Orthognathics Article List ARTICLE DESCRIPTION

Kits

SD900.008 Patient Specific Instrument and Planning Kit - Orthognathic Kit, Two Splints (Planning, splints)

SD900.009 Patient Specific Instrument and Planning Kit - Orthognathic Kit, One Splint (Planning, splint)

Kits (Titanium 3D printed)

SD980.001 TRUMATCH Orthognathic System Full Bimaxillary Surgical Kit (planning, plates, guides, splint)

SD980.002 TRUMATCH Orthognathic System Full Bimaxillary Surgical Kit without planning (plates, guides, splint)

SD980.003 TRUMATCH Orthognathic System Basic Bimaxillary Surgical Kit (planning, plates, guides)

SD980.004 TRUMATCH Orthognathic System Basic Bimaxillary Surgical Kit without planning (plates, guides)

SD980.005 TRUMATCH Orthognathic System Full Maxillary Surgical Kit (planning, plates, guides, splint)

SD980.006 TRUMATCH Orthognathic System Full Maxillary Surgical Kit without planning (plates, guides, splint)

SD980.007 TRUMATCH Orthognathic System Basic Maxillary Surgical Kit (planning, plates, guides)

SD980.008 TRUMATCH Orthognathic System Basic Maxillary Surgical Kit without planning (plates, guides)

SD980.009 TRUMATCH Orthognathic System Full Mandible Surgical Kit (planning, plates, guides, splint)

SD980.0010 TRUMATCH Orthognathic System Full Mandible Surgical Kit without planning (plates, guides, splints)

SD980.0011 TRUMATCH Orthognathic System Basic Mandible Surgical Kit (planning, plates, guides)

SD980.0012 TRUMATCH Orthognathic System Basic Mandible Surgical Kit without planning (plates, guides)

SD980.0013 TRUMATCH Orthognathic System Genioplasty Add-on Surgical Kit (plates, guides)

ARTICLE DESCRIPTION

Guides (Polyamide )

SD900.101 Patient Specific Guide, Mandible (genioplasty)

SD900.104 Patient Specific Guide Midface (maxilla)

Splints

SD900.105 Patient Specific Splint, Orthognathic, Intermediate

SD900.106 Patient Specific Splint, Orthognathic

Anatomic models

SD900.201 Anatomical Model, Mandible, Clear

SD900.206 Anatomical Model, Mandible - Orbit, Clear

SD900.209 Anatomical Model, Skull, Clear

SD900.231 Planned Model, Mandible, Clear

SD900.236 Planned Model, Mandible-Orbit Clear

SD900.239 Planned Model, Skull, Clear

SD900.301 Anatomical Model, Mandible, white

SD900.306 Anatomical Model, Mandible - Orbit, white

SD900.309 Anatomical Model, Skull, white

SD900.331 Planned Model, Mandible, White

SD900.336 Planned Model, Mandible-Orbit, White

SD900.339 Planned Model, Skull, White

ARTICLE DESCRIPTION

Additional Titanium 3D printed guides and plates

SD980.014 TRUMATCH Midface plate

SD980.015 TRUMATCH Midface Guide

SD980.016 TRUMATCH Mandible Plate Mini

SD980.017 TRUMATCH Mandible Guide

Other

SD900.091 Planning Session Orthognathic

SD900.092 Outcome Analysis Service

SD900.093 STL File Transfer Service

SD900.094 Segmentation Service