2025 EBl Vision Revised 4 - Zimmer Biomet Basic Principles and Biomechanical ConceptsP age 2 IndicationsPage 26 Bone Screw Insertion Technique... P age 10-12 Surgical Technique P age

Patent 6,277,119

EBIFIX

DYNAFIX® SYSTEM

®

DYNAFIX® VISION™

EXTERNAL FIXATIONSYSTEM

SURGICAL TECHNIQUE

CONTENTS

Basic Principles andBiomechanical Concepts..............Page 2

Indications.................................Page 26

Bone Screw Insertion Technique... Page 10-12

Surgical Technique...................... Page 13-25

Suggested Care Screw Site .......... Page 26

Sterilization.............................. Page 26

Introduction............................... Page 2

DYNAFIX® VISION

™

EXTERNAL FIXATIONSYSTEM

1

Component Review..................... Page 3-9

SURGICAL TECHNIQUE 2

INTRODUCTIONThe New DYNAFIX® Vision™ External Fixation System is a pin to barsystem, which will allow independent pin placement. With this systemsimple and effective external fixation can be applied. The DYNAFIX VisionSystem is versatile enough to be used as both temporary and definitivefixation. Temporizing measures include spanning transarticular fixationor non-spanning fixation for severe soft tissue damage or contamination.Definitive fixation uses include unilateral single bone fixation, hybridconfiguration and even use in hinge designs at the elbow and knee. Itcan also be applied to open book pelvic injuries as a resuscitive frameor a definitive fixator.

The simplicity and ease of use make this fixator friendly in theoperating room for quick applications. With the current trend fordelayed open reconstruction in peri-articular fractures, the DYNAFIX

Vision External Fixation System functions as an excellent means of“portable traction”. This allows the patients the benefit of soft tissuehealing while having the option of being at home and waiting for theirelective procedures. It allows the surgeon the benefits of getting thepatient out of the hospital quickly and readmitting for a well-plannedsafe surgery or for transfer to the appropriate physician.

Spanning fixator placement can easily be converted to the hybridconfiguration by simply adding a ring with tensioned wires to thearticular fragment. This assembly then connects to the previously placedpins and rods. Adaptation to the DYNAFIX hybrid or ankle frame canalso be preformed with the included components.

BASIC PRINCIPLESAND BIOMECHANICALCONCEPTSHalf-Pin Frame Biomechanics

The ideal frame stiffness is unknown. To increase frame stability,the following principles should be followed:

1. Use the largest diameter pin possible without the pin beinglarger than 1/3 the diameter of the bone.

2. Maximize pin spread within each fracture fragment.3. Place the Rod as close to the skin as possible, making sure

to leave enough room for additional soft tissue swelling.4. Placing pins out of plane will add stiffness in additional planes.5. Place a second Rod on the frame. (double stacked)6. Increase the number of pins in the construct.7. Using Rods of different materials can modify the stiffness of

the construct; stainless steel has the highest degree ofstiffness, followed by carbon fiber, and aluminum.

8. Maximize the pin spread within a fixed 5-hole clamp or 3-hole clamp.

SLM Rapid Rod-to-Rod Clamp

Part Number 14600

The SLM Rapid Rod-to-Rod Clamp has aserrated locking mechanism, which can betightened from either side of the clamp witha 5mm Allen Wrench. (Please note thedirectional arrow for locking etched on theclamp surface) The clamp was designed forrapid application and secure attachment to

the DYNAFIX® Vision™ Rods. The key featureof the SLM Rapid Rod-to-Rod Clamp is theability to secure the clamp from both sides in a single step locking procedure.

SLM Rapid 6mm Screw Clamp

Part Number 14605

The SLM Rapid 6mm Screw Clamp wasdesigned for ease of use and rapid locking.

A single step serrated lock allows for speedof application and secure purchase on rods,6mm bone screws and 6mm transfixingscrews. This clamp is locked with the 5mmAllen Wrench. The key feature of the SLM6mm Screw Clamp is the ability to snap onto both the rod and the shank of 6mm screwsand transfixing screws. This clamp also hasthe ability to lock to the shank of 5mmdiameter screws.

SLM Rapid Rod-to-Rod Clamp

COMPONENT REVIEW

SLM Rapid 6mm Screw Clamp

3

SL (single locking) Rod-to-RodRapid Clamp

Part Number 14005

The SL Rod-to-Rod Rapid Clamp has asingle serrated locking mechanism, which istightened with a 5mm Allen Wrench fromeither side of the clamp (please note thedirectional arrow for locking etched on clampsurface). The clamp was designed for rapid

and secure attachment to DYNAFIX® Vision™

Rods. The key feature of the SL Rapid Clampis the ability to secure the clamp with a singlestep locking procedure.

SL (single locking) Rapid Screw Clamps

SL Rapid 6mm Screw Clamps

Part Number 14040

SL Rapid 4mm Screw Clamps

Part Number 14045

The SL Rapid Screw Clamps were designedfor ease of use and rapid locking.A single step serrated lock allows for speedof application and excellent purchase onrods, bone screws and transfixing screws canbe utilized with this clamp. These clamps aresecured with the 5mm Allen Wrench.

SL Rod-to-Rod Clamp SL Rapid 4mm and 6mm Screw Clamps


3 and 5-Hole Clamps3-Hole Clamp

Part Number 14060

5-Hole Clamp

Part Number 14090

The 3 and 5-Hole Clamps were designed for multi-pin fixation, which increases framestiffness. The Clamp Cover Bolts are lockeddown with the 5mm Allen Wrench to secureBone Screws within the clamp. The 3/5 Postcan be attached to both sides of the clamp forRod or Bone Screw attachment. The 3/5 Postis secured to the 3 or 5-Hole Clamps with theT-handle Bone Screw Wrench.

DYNAFIX® Vision™ 3/5 PostPart Number 14240

The 3/5 Post is utilized with the 3-Hole and5-Hole Clamps primarily for Rod attachment,but can also be used for Bone Screw Clampattachment. The 3/5 Post is secured to eitherthe 3-Hole Clamp or the 5-Hole Clamp witha T-Handle Bone Screw Wrench or 9mmWrench.

Threaded end attaches to Clamps

Serrated Washer increasestorsional stability

Rod-to-Rod or Bone Screw Clamps can be securedto the body of the Post

Bone Screw Wrench is utilized to secure 3/5 Post to Multi-Pin Clamps

3-Hole ClampClamp CoverLocking Bolts

3-Hole Clamp

Serratedattachment for

3/5 Post

5-Hole Clamp

Clamp Cover Locking Bolts

Clamp Cover Locking Bolts

5

Bolts secure connector to Ring

Telescoping Bone Screw PostPart Number 14055

The Telescoping Bone Screw Post providesthe ability to place Bone Screws up to 3cmoff of Rods, allowing for increased versatilityin bone screw placement. The TelescopingBone Screw Post is attached to a Rod byutilizing a Rod-to-Rod Clamp.

Ring Connector Assembly (2-Bolt)Part Number 14069

The Ring Connector Assembly is used toconnect DYNAFIX® System Rings to theDYNAFIX Vision Rods to build a HybridConstruct. The Ring Connector Assembly issecured to the Ring with two locking bolts,which are tightened with a 5mm AllenWrench. A Rod- to-Rod Clamp is utilizedwith this assembly to attach to the body ofthe fixator.

Ring Connector Assembly (1 Bolt)Part Number 14330

The Ring Connector Assembly is used toconnect DYNAFIX System Rings to theDYNAFIX Vision Rods to build a HybridConstruct. The Ring Connector Assembly is secured to the Ring with one locking bolt,which is tightened with a 5mm AllenWrench. This assembly can be directlyattached to a Rod.

Bolt secure connector to Ring

Ring Connector - 1 Bolt

Rod-to-Rod Clampscan be secured to thebody of the Post

Ring Connector - 2 bolt

Bone Screw Coupler

LockingBolt

Rod-to-Rod Clampscan be secured to thebody of the Post

Telescoping Bone Screw Post


Connecting Rods150mm Connector RodPart Number 14360

100mm Connector RodPart Number 14355

50mm Connector RodPart Number 14350

The Connecting Rods were designed toincrease speed of application by having onerod Coupler already attached to the smallAluminum Connector Rods. The connectorrods also provide the 2 shortest rod lengthsavailable in the system. By having a shorteroverall length these connectors can serve asstruts or horizontal cross members toenhance the rigidity of a construct.

Double Rod ConnectorPart Number 14080

The Double Rod Connector can be utilized todouble stack a Frame to increase the rigidityof the construct. The double rod connectorcan also be used as a compression distractionmechanism between 2 parallel rods

DYNAFIX® Vision™ Rods

Part Numbers150mm Rod Steel - 14100200mm Rod Steel - 14105250mm Rod Steel - 14110300mm Rod Steel - 14115350mm Rod Steel - 14120400mm Rod Steel - 14125150mm Rod Aluminum - 14130200mm Rod Aluminum - 14135250mm Rod Aluminum - 14140300mm Rod Aluminum - 14145

350mm Rod Aluminum - 14150400mm Rod Aluminum - 14155150mm Rod Carbon - 14160200mm Rod Carbon - 14165250mm Rod Carbon - 14170300mm Rod Carbon - 14175350mm Rod Carbon - 14180400mm Rod Carbon - 14185

The DYNAFIX Vision Rods are available in three different material compositions. TheMaterials used in the rods vary in stiffnessand can be utilized to make a construct moreor less rigid. The Steel Rods are the Stiffestfollowed respectively by the Carbon andAluminum Rods. This allows up to 18choices for Rod selection. All Rods areoffered in a 9.5mm diameter. Carbon fiberrods have the added benefit of beingradiolucent and extremely lightweight.

Open RodCouplers

LockingBolts

150mm Connector Rod

100mm Connector Rod

50mm Connector Rod

Rod-to-Rod or Screw Clampscan be secured to the body ofthe Connector Rod

400mm Rod350mm Rod300mm Rod250mm Rod200mm Rod150mm Rod

Connecting Rods Double Rod Connector DYNAFIX Vision Rods

7

Metaphyseal BarMetaphyseal Bar 150mm

Part Number 14250

Metaphyseal Bar 180mm

Part Number 14255

The Metaphyseal Bars are used primarily forperi-articular fracture fixation with BoneScrews. Please note that these bars were notdesigned for small tensioned wire fixationand only Screw Clamps or Rod-to-RodClamps should be utilized with theMetaphyseal Bars. The bars have an angledstep off to allow for enhanced radiographicvisualization and surgical access.

DYNAFIX® Vision™ L-BarPart Number 14290

The low profile lightweight aluminum materialof the DYNAFIX Vision L-Bar was designed toprovide surgical access to the injury withoutcompromising strength. The component wasdesigned with room between two 45-degreebends to accommodate a Pin-to-Rod or Rod-to-Rod Clamp. This feature maximizes thepotential for Pin-to-Rod and Rod-to-Rodplacement on the DYNAFIX Vision L-Bar.

Transfixing Screw6mm Transfixing Screw

Part Number 14285

4mm Transfixing Screw

Part Number 14280

The 6mm and 4mm Transfixing screws weredesigned primarily for temporizing fixationtechniques, which typically span a joint andzone of injury. The transfixing screws aresecured to the frame with either style RapidBone Screw Clamp. Both sizes ofTransfixing Screws are equipped with adrilling tip and centrally threaded body. The6mm Transfixing Screw is unique in that ithas a removable drill tip. It is important tonote that the 6mm Transfixing Screw shouldnot be reversed while the removable drill tipis attached or it may become detached whilein bone or soft tissue.

DYNAFIX Vision L-Bar

Transfixing screw midshaft threading

4mm and 6mm Transfixing screws

6mm Transfixing screwwith removable tip

Metaphyseal Bar180mm Inner Diameter

Metaphyseal Bar150mm Inner Diameter


DYNAFIX® Vision™ 5/13mm L-WrenchPart Number 14270

The DYNAFIX Vision 5/13mm L-Wrench can be used to Lock both the Internal HexLocking Bolts with the 5mm end and TheExternal Hex Locking Bolts with the 13mmend. This wrench can also be utilized as acounter torque instrument for the RapidClamps by placing the 13mm end over the

External Hex Bolt when loosening theInternal Hex Bolt for independent reduction maneuvers.

DYNAFIX Vision Ratcheting T-Wrench 13mm

Part Number 14275

The Ratcheting T-Wrench 13mm can beused to lock the External Hex Bolts on the Rapid Clamps.

DYNAFIX Vision 9mm Wrench

Part Number 14245The DYNAFIX Vision 9mm Wrench isutilized for the DYNAFIX Vision 3/5postattachment to the 3-Hole or 5-Hole fixed pin clamps.

DYNAFIX Vision Ratcheting T-Wrench 13mmL Wrench 9mm Wrench

9

1. Pre-operative planning is recommendedprior to application of this device. Assesspotential screw site location based onavailable bone stock and soft tissueconsiderations. Prep and drape in routinesterile fashion.

2. Obtaining a preliminary reduction isrecommended. The first bone screw is

generally inserted in the shortest or mostdifficult fragment. Assess available bonestock for desired bone screw position.When possible, allow 2 1/2 cm ofdistance between fracture site and thefirst bone screw.

3. A 1-cm incision is made and bluntdissection continued to bone.

4. A Trocar and appropriate length softtissue guide are then utilized to identify the center of the bone and toestablish the orientation of the screwtract to be pre-drilled. The orientation of the insertion of the bone screwshould be perpendicular to the long axis of the bone to maximizebiomechanical stability.

BONE SCREW INSERTION TECHNIQUEPREOPERATIVE PLANNING AND BONE SCREW INSERTION


NOTE: Care must be taken to avoid over-penetration. Due to the tapered design bone screws must not be backed out or they will lose purchase.

5. Once the screw site is selected usegentle pressure to maintain contactbetween the soft tissue guide and thecortex of the bone. Extract the Trocar.The soft tissue guide may now betapped with a mallet if needed toengage the bone.

6. Insert appropriate drill guide into the softtissue guide.

4mm Screw Shank Diameter2.7mm 2.7mm 3.3/3.0mm Cortical2.0mm 2.0mm 3.0/2.5mm Cortical

(Bone screw diameter should not exceed1/3 diameter of bone)

7. Insert matching drill bit with drill stopinto the drill guide. Drill the near cortex.Drilling is halted upon contact with thefar cortex. Be sure pre-drilled screw tractis perpendicular to the long axis of thebone.

Note:Drill Guide Drill Bit Screw6mm Screw Shank Diameter4.8mm 4.8mm 6/5mm Cortical3.2mm 3.2mm 6/5mm Cancellous3.2mm 3.2mm 4.5/3.5mm Cortical2.9mm 2.9mm 3.5/3.2mm Cortical

11

8. Upon contact with the far cortex the drillstop is re-positioned and securedapproximately 5mm from the base of thedrill guide. The drill stop will preventover penetration of the drill bit intounderlying soft tissue structures. The farcortex is then drilled.

9. After bi-cortical penetration of thedrill, the drill and drill guide arewithdrawn. Maintain contact andposition of the soft tissue guide.

10. The appropriate length screw is theninserted through the soft tissue guide.The bone screw T-Wrench is used to

advance the screw into the bone. To obtain optimal purchase, all bonescrews must be bi-cortical with no less than 2mm protruding from the far cortex and about 5mm remainingoutside the near cortex. Imageintensification is utilized to confirmdepth of penetration.


• Unstable Pelvic Fractures• Open Book Pelvic Fractures• Highly Contaminated wounds• Cannot physiologically tolerate an extended

surgical procedure• Supplementing Posterior Fixation

Two pins are applied to either iliac crest andconnected with an anterior frame.The ASIS is identified and the insertionpoints are 2cm posterior for the first pin. Thesecond pin is inserted approximately 2-3cmposterior to the first along the crest.A small incision is centered over the iliaccrest/tubercle and sharply dissected down to

bone. The medial and lateral borders of thecrest are identified. The 4.8mm drill and drillguide are then used to drill the cortex in themiddle to a depth of approximately 1cm. The6mm pin is then inserted through the softtissue sleeve. Care must be taken to ensurethat the pin does not penetrate the inner orouter Table of the crest.

The second pin is inserted in a similarfashion. Screw clamps are used to connectthe two half-pins on either side. The frame istrapezoidal in shape and fixed such that thepatient can sit up in bed. Surgeons areencouraged to achieve reduction by applying

a compressive force across the pelvic ring bypushing against the greater trochanter. It isnot recommended to push against the screwclamps. This will increase forces on the pinto bone interface. This can also increase orexacerbate posterior instability. Pushing fromthe greater trochanter will provide an evencompressive force across the pelvic ring.Once adequate compression has beenachieved, all locking components should bedefinitively tightened. Traction is applied asmay be necessary.

SURGICAL TECHNIQUEPELVIC FRACTURES

DYNAFIX® Vision™ Pelvis Iliac Crest – anterior and lateral view DYNAFIX® Vision™ Pelvis anterior column – anterior and lateral view

13

• Pediatric femur fractures• Vascular injury with prolonged

ischemia time• Severe soft tissue compromise• Cannot physiologically tolerate an extended

surgical procedure

Half-pins are usually inserted from the lateral side of the femur. Ideally pins shouldbe placed obliquely along the lateral intra-muscular septum so that the pin transfixes theleast amount of muscle. For extremelyunstable fractures a delta frame can beconstructed with additional pins placed fromanterior to posterior or frames

can be double stacked to increase stiffnessand rigidity. A minimum of two pins areplaced distal and proximal to the fracture.Using traction and manipulation, the fractureis reduced and the clamps tightened. The pinsare connected to a rod with 6mm screwclamps and definitively tightened.

MIDSHAFT FEMUR FRACTURES

Midshaft Femur single stack – anterior and lateral view Midshaft Femur double stack – anterior and lateral view

Alternatively the pins can be placed freehandin each fracture fragment, connected withineach fragment using a short rod and two

6mm screw clamps. A Rod-to-Rod Clamp isthen used to connect the two bars together.The fracture is reduced using manual

traction and the clamps are tightened. The frame is typically double stacked toincrease frame stiffness.

INDEPENDENT PIN PLACEMENT FEMORAL FIXATION


Midshaft Femur 5-hole – anterior and lateral view

Using two 5-hole clamps a minimum of twopins are placed proximal and distal to thefracture site. The first pin in each fragment isplaced freehand and the second is placedusing the pin clamp as a guide to insure

parallel pin placement within the clamp. Thepins should be placed through the first andlast holes of the pin clamp to maximize thespread of the pins in each fracture fragment.The pin clamps are connected using an

anterior and a posterior bar attached to the3/5 Posts with Rod-to-Rod Clamps. Manualtraction is then used to reduce the fractureand all clamps are tightened definitively.

FEMORAL FIXATION FIXED CLAMPS

15

• Vascular injury with prolonged ischemia time

• Severe soft tissue compromise

• Cannot physiologically tolerate an extendedsurgical procedure

• Highly contaminated wound

TIBIA FRACTURES, MIDSHAFT FRACTURES

Tibial pins are usually placed either in an antero-medial direction starting on theanteromedial face of the tibia or in ananterioposterior direction starting just medial

to the tibial crest. A minimum of two pins areplaced freehand in each fracture fragmentand connected to a Rod using 6mm ScrewClamps. The two Rods are then connected

using a Rod-to-Rod Clamp. A reduction isperformed using manual traction and allclamps are definitively tightened.

INDEPENDENT PIN PLACEMENT - SINGLE STACKED TIBIAL FIXATION

Midshaft Tibia reduction frame – anterior and medial view


Midshaft Tibia single stack – anterior and medial view Midshaft Tibia double stack – anterior and medial view

Tibial pins are usually placed either in an anteromedial direction starting on theanteromedial face of the tibia or in ananterioposterior direction starting just medialto the tibial crest. A minimum of two pins are

placed freehand in each fracture fragment andconnected to a Rod using 6mm Screw Clamps.The two Rods are then connected using aRod-to-Rod Clamp. A reduction is performedusing manual traction and all clamps are

definitively tightened. To increase thestiffness of the frame a second Rod can be placed.

INDEPENDENT PIN PLACEMENT - DOUBLE STACKED TIBIAL FIXATION

17

The DYNAFIX® Vision™ External FixationSystem has Telescoping Bone Screw Poststhat can be placed on the rod allowing pins to be placed at different angles into fracturefragments. This allows great versatility forpin placement and is useful for proximal and

distal fractures as well as those with multiplefracture lines. A 6mm Screw Clamp can beused in the less comminuted fragment andthen pins can be placed off the bar connectedto the pin clamp into the smaller and/or morecomminuted fragment using the Telescoping

Bone Screw Post. They can also be used toplace pins into a segmental fracture fragment.A reduction is performed using manual tractionand all clamps are definitively tightened.

INDEPENDENT PIN PLACEMENT - BOX FRAME TIBIAL FIXATION

• Vascular injury with prolonged ischemia time

• Severe soft tissue compromise• Cannot physiologically tolerate an extended

surgical procedure• Highly contaminated wound• Comminuted fractures that may interfere

with internal fixation insertion techniques

To gain fixation in a small proximal or distalfragment, pins can be placed out of plane andconvergent. A hybrid ring with variable bonescrew carriages or a Metaphyseal Bar withindependent pins can be used for fixation inthe small fragment distally or proximally.Fixation in the large fragment can beobtained using parallel pins placed in a

5-hole clamp or pins can be placedindependently and connected with a rod and6mm screw clamps. A minimum of two pinsare placed distal and proximal to the fracture.

PROXIMAL AND DISTAL THIRD FRACTURES TIBIAL FIXATION

Metaphyseal Tibia/Segmental – anterior proximal, anterior distal and angled proximal view


• Open Fractures• Severe soft tissue compromise• Cannot physiologically tolerate an extended

surgical procedure• Highly contaminated wound

The proximal pins are placed from lateral tomedial, and the distal pins either from lateralto medial or posterior to anterior. The pinsmust be placed using open incisions, with thebone visualized, and using guides to protectthe neurovascular structures. A simple single

stacked frame is usually sufficient for thehumerus. Pins could also be placed using the3 or 5-Hole Clamps, and if needed, the framecan be double stacked. A reduction isperformed using manual traction and allclamps are definitively tightened.

MIDSHAFT HUMERUS FRACTURE INDEPENDENT PIN PLACEMENT

Midshaft humerous – anterior and lateral view

19

Spanning Knee anterior 5 hole – anterior and lateral view Spanning Knee independent knee – anterior and lateral view

• Complex open distal femur fractures notamenable to acute fixation

• Unstable knee dislocations• Complex tibial plateau fractures with soft

tissue compromise• Floating knee fractures

The femoral pin insertion sites are identifiedas proximal to all fractures and all futureInternal fixation. Pins are inserted on theanterior surface of the femur. Use the 5-HoleClamp and aim to insert two pins through the1st & 5th screw positions. Utilizing a smallskin incision dissect down to bone through

the quadriceps muscle using blunt dissection.Following pin insertion protocol proceed toinsert the first screw. In order to maintain aparallel relationship to the first pin insert thesecond pin using the 5-Hole Clamp as aguide. The Tibial Pin insertion sites areidentified as distal to all fractures and allfuture Internal fixation. Pins are inserted onthe anteromedial surface of the tibia. Use 5-Hole Clamp and aim to insert two pinsthrough the 1st & 5th screw positions.Utilizing a small skin incision dissect downto bone using blunt dissection. Following pininsertion protocol proceed to insert the first

screw. In order to maintain a parallelrelationship to the first pin insert the secondpin using the 5-Hole Clamp as a guide. One 5-Hole Clamp is used for each set of pins.Alternatively, you can use independent 6mmScrew Clamps for each pin. The femoral andtibial pins are connected to each other withRods and Rod-to-Rod Clamps anterior to theknee joint. Using traction and manipulation,the fracture is reduced and the clampstightened definitively taking care to keep theknee flexed approximately 15 degrees torelax the posterior neurovascular structures.

KNEE SPANNING ANTERIOR FRAME


• Distal tibia fractures• Plafond fractures with or without fibula

fixation• Unstable ankle fractures or dislocations• Severe soft tissue compromise

Tibial pin sites should be planned inaccordance with secondary or definitiveprotocols in mind. Pins are inserted on theanteromedial surface of the tibia. Use the 5-Hole Clamp and aim to insert two pinsthrough the 1st & 5th screw positions.Utilizing a small skin incision dissect downto bone using blunt dissection. Following pin

insertion protocol proceed to insert the firstscrew. In order to maintain a parallelrelationship to the first pin insert the secondpin using the 5-Hole Clamp as a guide. The6mm calcaneal pin is inserted from medial tolateral. A small incision is made posteriorand distal to the neurovascular bundle, andblunt dissection is made down to the bone.Following pin insertion protocol the calcanealpin is inserted into the bone parallel to theankle joint. A 4mm pin is now inserted fromthe medial side into the medial and middlecuneiform. A small incision is made over themidpoint of the medial cuneiform and bluntdissection is carried down to the bone.

Following pin insertion protocol insert the4mm pin staying parallel to the ankle joint.The pin should be placed through the medialcuneiform and into the middle cuneiform.Connect the pins in a triangular formationusing the 6mm Screw Clamp, 4mm ScrewClamp, and Rods. Apply traction to the legalong its long axis, using the calcaneal pin.Once adequate reduction is achieved, tightenthe clamps over the tibia and calcaneus. Thefoot is then dorsiflexed to the neutral positionand clamps connecting the cuneiform pinsare tightened. All clamps should be checkedfor definitive locking.

ANKLE SPANNING HALF PIN FRAME

Spanning Ankle Triangular frame – anterior, anteromedial and medial view

21

Spanning Ankle Transfixing screw frame – anterior and medial view

• Distal tibia fractures• Pilon fractures with or without

fibula fixation• Unstable ankle fractures or dislocations• Severe soft tissue compromise

Tibial Pin sites should be planned inaccordance with secondary or definitiveprotocols in mind. Pins are inserted on theanteromedial or anterior surface of the tibia.Pins can be placed independently using 6mmBone screw clamps or through a fixed 5-Holeclamp. Utilizing a small skin incision dissect

down to the bone using blunt dissection.Following pin insertion protocol place thetibial bone screw cluster. The 6mmtransfixing screw is inserted from medial tolateral. A small incision is made posteriorand distal to the neurovascular bundle, andblunt dissection is made down to the bone.Following pin insertion protocol the calcanealtransfixing screw is inserted into the boneparallel to the ankle joint. Transfixing screwsare available in 4mm and 6mm sizes. Bonescrew clamps are now attached to either sideof the transfixing screw and appropriate size

rods are attached. The proximal end of boththe medial and lateral rod, are now attachedto the most proximal pin in the tibia withbone screw clamps. The distal pin in the tibiais attached to the construct with a bone screwclamp and the appropriate size rod. The rodattached to the distal pin in the tibia is nowconnected to the medial and lateral rods withrod to rod clamps. Apply traction to the legalong its long axis, using the calcanealtransfixing screw. Once adequate reduction isachieved, tighten all clamps. All clampsshould be checked for definitive locking.

ANKLE SPANNING TRANSFIXING SCREW FRAME


Tibial external fixation can be used fortemporary or definitive fixation. Externalfixation is utilized for patients who cannotphysiologically tolerate internal fixation,have a vascular injury with prolongedischemia time, or have a severe soft tissueinjury. In addition highly comminutedproximal or distal third fracture patterns mayinterfere with internal fixation insertiontechniques, necessitating an alternativeoperative modality. Intra and peri-articularfractures where the fracture pattern andavailable bone stock preclude theintroduction of larger diameter bone screws.

The first step in placing a hybrid externalfixator in the distal tibia is to obtain ananatomic reduction of the joint surface. Thiscan be accomplished percutaneously if thejoint surface is non-displaced the externalfixator can be placed early. If formal openreduction needs to be performed, thendelayed reconstruction is recommended afterallowing adequate time for soft tissuehealing.

First choose an adequate size ring to allow 2 finger breadths distance around the ankle.Elevate the ankle on 4-5 cloth towels to allowclearance to place the tensioned wires. Thefirst tensioned olive wire is placed fromposterolateral through the fibula exitinganteromedial. The wire should exit medial tothe tendon of tibialis anterior to avoidneurovascular injury. The second wire isthen placed posteromedial to anterolateral.Posteromedial placement should be justanterior to posterior medial edge of the tibiaand exit should be between the peronealtendons and toe extensors. This wireplacement will allow for maximum spreadutilizing the “safe zones” as described byBehrens and Searls to avoid neurovasculardamage.

The wires are then connected to the ring by use of the variable wire carriages andtensioned to the appropriate level.

Two 6mm cortical pins are placed in theproximal diaphysis by drilling with the4.8mm drill bit. This system allows for theversatility of either using a 5-Hole Clamp or

for independent pin placement. Once thehalf pins are inserted the distal and proximalsegments are attached by using the 9.5mmcarbon fiber rods.

When using the 5-Hole Clamp a 3/5 Post isplaced on either side of cluster. This allows a Rod-to-Rod Clamp to attach the rod to theperi-articular segment and the ring.Connection to the ring is accomplished viathe Ring Connector Assembly that connectswith either one or two screws to the ring.Alternatively the rod can be connected to thering via the post extension of the wirecarriage and the use of a Rod-to-Rod Clamp.

An alternative method of connecting the halfpins to the rods is by direct connection withthe use of Screw Clamps. A triangular(delta) type configuration is easily made.

Once all connections have been establishedthe fracture is reduced and aligned by the useof ligamentotaxis. The frame is tightenedand fluoroscopy imaging is done to confirmlength, alignment and rotation. Smalladjustments can be easily achieved by

HYBRID RING FIXATION DISTAL TIBIA

23

loosening the appropriate clamp to allowcorrection in the plane which adjustment isneeded. Once alignment has been obtainedadditional rods can be added to increaseframe stiffness and rigidity. For example ifthe fracture is tending to collapse into a varusa medial strut will maintain medial lengthand keep a neutral position.

The final step involves placement of a pointof fixation in the peri-articular segment. Thiscan be either a half pin or tensioned wire.Final full length x-rays centered at the ankleshould be obtained prior to waking thepatient from anesthesia to assure adequatealignment and reduction has been obtained.

Distal Tibia Hybrid – anterior and medial view


Tibial external fixation can be used fortemporary or definitive fixation. Externalfixation is utilized for patients who cannotphysiologically tolerate internal fixation,have a vascular injury with prolongedischemia time, or have a severe soft tissueinjury. In addition highly comminutedproximal or distal third fracture patterns mayinterfere with internal fixation insertiontechniques, necessitating an alternativeoperative modality. Intra and peri-articularfractures where the fracture pattern andavailable bone stock preclude theintroduction of larger diameter bone screws.

For tibial plateau fractures the same basicsteps as for the Pilon should be followed.Fixation in the peri-articular (proximal tibia)segment by placement of tensioned olivewires. Half-pin placement in the distal to thefracture site. Followed by connecting theframe and reducing the fracture. Addingsupporting struts to prevent collapse and lossof reduction and final placement of a thirdfixation point in the metaphysis.

Again, anatomic reduction of the articularsurface is mandatory. If no incisions arenecessary immediate hybrid fixation can beperformed. If an open reduction is required,trans-articular fixation should be performed

first, with definitive reconstruction delayeduntil the soft tissue envelope has a chance toheal, typically 7 to 14 days.

Safe wire placement is as follows. The firstwire is placed posterolateral, just in front ofthe fibula exiting anteromedial. As opposedto the ankle the fibula head should not beincluded in the fixation. The second wireshould be placed from posteromedial, anteriorto the medial head of the gastrocnemius,exiting anterolateral. Wire divergence should maximized, as described by Tornettaand Geller, to increase the strength of theconstruct. The third wire will be placedanterior to point of intersection of the firsttwo wires, which will also increase thestrength of the construct. Whenever possible,wires should be kept a minimum of 15mmfrom the joint surface to avoid penetratingthe knee joint capsule. This will decrease the associated risk of septic arthritis.

The remaining portion of this procedure is identical to that for Pilon fractures. Theappropriate diameter ring should be used.Keep in mind, that if hybrid fixation is doneacutely the proximal soft tissue envelope maysignificantly swell, thereby making the 2/3rdsring chosen to small. In the acute setting erron too large of a ring.

HYBRID RING FIXATION TIBIAL PLATEAU

Proximal Tibia Hybrid – anterior and anteromedial view

25

SUGGESTED SCREW SITE CAREDry sterile gauze is wrapped around the shanks of the bone screws to preventpistoning of the soft tissues on the bone screws. A solution of 2% hydrogenperoxide and sterile water should be used on the pin sites until the woundshave healed and sutures are removed. The patients are then instructed toshower on a daily basis using soap and water and reapply gauze dressings as a means for routine bone screw hygiene. Screw sites should be monitoredduring subsequent clinical visits. All fixator locking components should beevaluated for tightness during subsequent clinical visits.

STERILIZATIONThe EBI X FIX® System is provided nonsterile and must be sterilized prior to use. Repeated sterilization of carbon fiber components is notrecommended. All packaging materials must be removed prior to sterilization. All fixator components should be sterilized in a loosened state such that components may move freely. The following steamsterilization parameters are recommended.

Cycle: Vacuum SteamTemperature: 270° F/132° CTime: 8 minutesNote: Allow for cooling

Individuals or hospitals not using the recommended method, temperature, and time are advised to validate alternative methods or cycles using anapproved method or standard.

INDICATIONS The DYNAFIX® Vision™ External Fixation Systemis a modular external fixator intended for use in the treatment of bone conditions includingleg lengthening, osteotomies, arthrodesis,fracture fixation, and other bone conditionsamenable to treatment by use of the externalfixation modality.

Caution: Federal Law (USA) restricts thisdevice to sale by or on the order of a physician.

Warning: This device is not approved for screw attachment or fixation to the posteriorelements (pedicles) of the cervical, thoracic, or lumbar spine.

See package insert for full prescribinginformation.

To reorder call:(800) 526-2579Fax (800) 524-0457

EBI, as the manufacturer of this device, andtheir surgical consultants, do not recommendthis or any other surgical technique for use on aspecific patient. The surgeon who performs anyimplant procedure is responsible fordetermining and utilizing the appropriatetechniques for implanting the device in eachindividual patient. EBI and their surgicalconsultants are not responsible for selection ofthe appropriate surgical technique to be utilizedfor an individual patient.


P/N 192291L 12/03

EBI, L.P.

100 Interpace Parkway Parsippany, NJ 07054 www.ebimedical.com

1-800-526-2579

Michael Sirkin, M.D. Assistant Professor Dept. of OrthopaedicsNew Jersey Medical School, Newark, NJ

Nirmal Tejwani, M.D. Assistant Clinical Professor Dept. of OrthopaedicsNYU-HJD, NY, NY

Philip Wolinsky, M.D. Associate Clinical Professor Dept. of OrthopaedicsUC Davis, Sacramento, CA

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