Rigid External Distraction RED II System

Osteodistraction

Rigid External Distraction RED II System

2

Clinical example: LeFort I region Clinical example: LeFort III region

Introduction

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Distraction Osteogenesis has become an essential

treatment modality for patients with craniomaxillofacial

anomalies. The incredible success of the RED (rigid

external distractor) for the treatment of severe maxillary

hypoplasia associated with cleft palate patients has led to

the application of the device to treat many more complex

craniofacial anomalies. With the introduction of the RED II,

the craniomaxillofacial surgeon now has the flexibility to

treat patients requiring Le Fort II, III, or Monobloc

advancements. Now, more craniofacial patients with

maxillary and midface skeletal hypoplasia can be

effectively treated utilizing the principles of distraction

osteogenesis. This technique has unique advantages over

traditional surgical methods for the treatment of patients

with severe maxillary and midface deficiencies. Some of

these important advantages include the following:

● Ability to successfully treat patients at any age including

childhood.

● Ability to treat patients with severe skeletal

deficiencies who are not amenable to, or would receive

compromised results with, conventional orthognathic

surgery.

● Ability to focus treatment on only the affected

skeletal region.

● Ability to treat severe deformities with minimal

associated morbidity and at reduced cost.

● No bone grafting or internal fixation devices required.

The Martin Rigid External Distraction (RED) System

provides the means to obtain predictable and consistent

results in maxillary and midface distraction. This system

was designed to provide the surgeon the ability to deliver

controlled rigid distraction forces without the need for

internal hardware. The advantages of this Rigid External

Distraction (RED) system are multiple and include

the following:

● Allows rigid distraction forces.

● Allows multidirectional, accurate distraction.

● Allows for multiplanar adjustability of distraction forces at

any time during the distraction procedure.

● Is easily and quickly placed at the time of the osteotomy.

● Is easily and quickly removed in the office or

clinical setting.

● Allows for unlimited distraction.

● Allows for predictable results.

● Assures patient compliance during the

distraction procedure.

This lightweight and fully adjustable Rigid External

Distraction (RED) System demonstrates dramatic

distraction results in patients with a wide variety of

maxillary and midface hypoplasias. When utilized

properly, this system provides an essential treatment

modality for patients with severe midface deficiencies.

Rigid External Distraction RED II SystemPlacement of the RED System

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Fig. 1

Fig. 2

Fig. 3

Step 1 Assemble the RED components as shown in this manual.

Step 2 Adjust transverse dimension of RED by sliding each distractor segment along parallel carbon rods. Lock the distractor segments into the desired position. There should be approximately 2-3 cm distance between the inner aspect of the RED and the scalp. (Figure 1)

Step 3 Adjust vertical position of the RED. The RED should parallel the Frankfort Horizontal Plane and be placed at a vertical distance approximately 2-3 cm above the superior margin of the auricular helix on each side. (Figures 2 and 3)

Step 4 Placement of titanium trial positioning pins. Once transverse and vertical positions of the RED have been determined, the titanium trial positioning pins are placed in alternate screw holes to position the RED for placement of the final titanium fixation screws.Warning: It is extremely important not to use the titanium trial positioning pins as permanent fixation for the RED, as these may cause scalp erosion if left on the scalp long-term.

Step 5 Placement of permanent titanium fixation screws. Place permanent titanium fixation screws through the corresponding hole in the distractor segments until the pointed end of the screw has reached the scalp. Tighten the titanium fixation screws by hand in a symmetrical fashion on either side until tight to fingertip pressure.Finish tightening all titanium fixation screws utilizing the Martin torque wrench. Tighten to approximately 8 pounds per square inch for adults and 4 pounds per square inch for children.

1. No prepping of the scalp is required.Have the patient shampood their hair the night before surgery. No shaving ofthe hair at the screw site is required.For patients with very long hair, have an assistant hold the hair out of the waywhile placing titanium fixation screws toprevent entanglement.

2. No postoperative care of the screw siteis required. The patient may shampooand dry their hair normally with theRED in place.

3. Temporary placement of the verticalbar at the time of placement of the REDis helpful in orienting cranial and facialmidlines, as well as distance to the face.

4. After placement of the RED, the vertical bar and horizontal cross-barare generally removed and replacedpostoperatively on the date of initiationof distraction.

5. A minimum of 2 titanium fixation screws per side are required to securethe RED. Three titanium fixation screwsper side is preferred. The tightness of the titanium fixation screws can bechecked with the torque wrench at any time during the postoperativeperiod in the clinic.

6. In patients with prior craniotomiespalpate the skull prior to screwplacement to be certain that there is solid bone under the scalp at thelocation where you want to place the titanium fixation screw.

Step by Step Instructions

Additional Considerations

Rigid External Distraction RED II SystemDistraction Protocol

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Step by Step Instructions

Distraction Initiation

Following discharge from the hospital (usually 24 hours after surgery) the patientreturns to the office on the 4th or 5th postoperative day for follow-up. At this timethe following is performed:

Step 1 Placement of vertical bar.

Step 1 Placement of horizontal cross-bar with spindle units containing distraction screws. Check that sufficient distraction distance for the planned advancement has been allowed in the distraction screws.

Step 1 Connection of distraction screws to the traction hooks of the intraoral appliance with surgical wire.

Step 1 Distraction is begun at the rate of 1mm per day. One complete revolutionof the distraction screw is equal to 1/2 mm. Therefore, for a distraction rate of 1mm per day the patient is instructed to turn each screw 2 revolutions per day. Preferably this is performed with 1 revolution in the morning and 1 revolution in the evening for each distraction screw.The patient is seen every 5-7 days during the distraction period to check progress and make alterations in the rate and/or direction of distraction.

Active Distraction

The patient is monitored weekly during the active phase of distraction. Duringthis time adjustments in the rate of distraction can be made based upon clinicaljudgement. Adjustments in the position of the horizontal cross-bar in the verticaldimension can be made in the clinic. This allows for changes in the vector ofdistraction depending on the clinical requirements. Rotations of the occlusal planecan be controlled by adjusting the vertical position of the horizontal cross-barand/or by rotation of the spindle units containing the distraction screws. This maybe done at any time during the distraction process. These adjustments areperformed readily in the clinic with no patient discomfort.

With the RED system an unlimited amount of horizontal distraction can beperformed. If the distraction screws have reached a maximum level ofadvancement, the surgical wires connecting the distraction screws and thetraction hooks of the orthodontic appliance are disconnected and replaced after resetting the distraction screws for additional distraction. The amount of overjet can be completely controlled with the distraction process.

Retention phase.

Upon completion of distraction, the RED is left in place without activation for 2-3weeks to allow for rigid retention. The RED is then removed and an additional 4-6weeks of nighttime elastic retention is utilized with a standard orthodontic facemask. The extraoral traction hooks of the intraoral appliance are cut at the time ofremoval of the RED and the elastic retention performed at nighttime only is donethrough use of the intraoral hooks previously built into the appliance.

Rigid External Distraction RED II SystemIntraoral Splint

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Fig. 1

Fig. 2

Fig. 3

Fig. 4

In order to apply traction to the maxilla through the dentition, a rigid intraoralsplint needs to be fabricated. Orthodontic bands with 0.050 inch headgeartubes are fitted either on the second primary molars (children under 6 years) or first permanent molars and an alginate or compound impression is taken ofthe maxillary arch. The bands are transferred and the impression is poured withdental stone. The splint is made on the working model, with 0.045 or 0.050stainless steel rigid orthodontic wire. If the patient does not have orthodonticbrackets, the labial and palatal wires are bent in close contact with most of themaxillary teeth. If the patient has orthodontic brackets, the labial wire has to bebent outward and gingivally to clear the existing appliances. If needed, atranspalatal bar can be added to increase rigidity. Connecting wires betweenthe labial and palatal arches through the embrasures between the lateral andcanine teeth bilaterally or in any other area where the wire can be passedwithout interfering with the occlusion may also be incorporated (Fig. 1).

The basic design of the splint has been successfully used in patients undergoingprotractive face mask therapy. The rigid splint is then tried in the patient,assuring adequate fit, and two markings are done on the labial wire just medialto both commissures. The splint is removed from the patient’s mouth and twostraight pieces of 0.060 inch rigid stainless steel orthodontic wire are solderedperpendicular to the labial wire. (Fig. 2) These vertical wires have a short endtowards the vestibule that eventually will be used as intraoral hooks. The longend of the vertical wire is marked while the device is in the mouth to bend theexternal traction hooks. The wire is bent under, over and anterior to the lip. Theends of the wire are bent in a circle to eliminate sharp ends and to have a rigideyelet from where to apply the traction. This traction eyelet is positioned at thelevel of the floor of the nose or at any other desired level to control rotationalmovements of the maxilla (Fig. 3). The purpose of this external hook is to avoidany irritation to the lip while applying traction and also to control the direction ofthe traction forces, relative to the approximate center of resistance of the maxilla.The completed splint is cemented in the clinical setting and at the time orsurgery, circumdental wires are passed through most of the maxillary teeth toincrease rigidity and stability (Fig. 4, 5).

In certain instances, it becomes necessary to do an intraoral splint to anabnormal arch form, knowing that after distraction, the patient will undergofurther orthodontic treatment or surgical orthodontic expansion of the arch.If it is determined that the arch will be expanded surgically at the time of therequired osteotomy for distraction, the cast has to be cut, aligned, and the splint made to the newly desired maxillary arch form.

Step by Step Instructions

Rigid External Distraction RED II SystemIntraoral Splint

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Fig. 5

Fig. 6

Fig. 7

Fig. 8

It is preferable to do arch expansion procedures before or after maxillarydistraction to avoid moving the maxillary bone simultaneously in severaldirections where vector control can become more difficult. If the cliniciandesires to expand simultaneously with anterior distraction, an expansion screwcan be incorporated into the splint, which has to be split into two segments,but the rigidity of the device may be compromised.

The intraoral splint can also be made with a commercially available orthodonticheadgear face bow with a long external outer and an inner bow without loops.(Fig. 6) The inner bow is bent to the desired arch form, and the loose ends arepassed through the headgear tubes for future soldering. The outer bow is bentdownward and anteriorly, in order to clear the upper lip. The advantage of usinga face bow is that the wires for the traction hooks (outer bow) are strong andrigid and the traction hooks are already soldered (Fig. 7). It is difficult to use theface bow in maxillary arches with poor arch form or in young children becauseit is difficult to adapt the inner bow to the teeth, making circumdental wiringdifficult.

The external traction hook can be further strengthened by soldering a piece of wire diagonally to decrease the cantilever effect at the free end of the hook.(Fig. 8)

In younger patients in which cooperation might be a factor, the splint can becemented after the patient is anesthetized and before surgical preparation in the operating room. In cases in which a splint has been made to a surgicallycreated arch form, the splint has to be cemented after the maxillary osteotomyis completed and the segments have been mobilized. This procedure can bedifficult, as the segments are mobile and maintaining a dry field can be difficult.Adequate assistance from the surgeon and assisting personnel are required tohold the segments in place and maintain a dry field.

Figure 5 – Intraoral appliance used to deliver distraction force to the maxilla.Note circumdental wiring.

Figure 6 – Intraoral splint made with an orthodontic headgear face bow withlong external outer bow.

Figure 7 – Completed intraoral appliance made from a headgear face bow.The outer bow has been bent to form the traction hooks. Note small solderedhooks to be used during the facial mask retention phase after distraction.

Figure 8 – Reinforced External Traction Hook

Step by Step Instructions

Rigid External Distraction RED II SystemLeFort II, III, Monoblock Procedures

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Removal of REDStep by Step Instructions

Modification for Monoblock Advancement:

During Monoblock advancement, the orbital-maxillofacialcomplex is mobilized and advanced. If a fixed halo isutilized for distraction, the advancement is limited by thefixed position of the halo. Thus, the surgeon must placethe halo sufficiently forward to provide enough space foradvancement or risk having to reposition the halo with a subsequent operation. This represents additionalmorbidity to an otherwise straightforward and minimallyinvasive procedure.

To avoid the two previously mentioned limitations of thetechnique, the fixed cranial halo has been modified to beadjustable. The device consists of a base with screwperforations for fixation. The superior and posterior partof the base contains a stop through which an activatingscrew has been added. The anterior part of the screwextends into a movable part, which slides above the fixedbase. (figure 1) This adjustability allows the surgeon toadvance the anterior part of the cranial halo as theadvancing supraorbital rims approximate the halo.

To provide control of the monoblock segment duringadvancement, and to adjust the vectors of distraction, twolevels of anchorage to the moving segments are utilized.A superior one connected to specially designed platesover the supraorbital rims and percutaneous pins thatexit through the eyebrows. This allows for a hidden scar.The inferior anchorage for the advancement is providedby two traction hooks anchored to an intraoral appliance.Superior and inferior horizontal bars are utilized. Eachhorizontal bar has a right and left distraction screw. Thedistraction screws are connected to the superior tractionpins and to the dentally anchored traction hooks utilizingsurgical wire gauge 26.

Distraction Protocol:

After careful preoperative planning the distraction vectorsare planned. All the necessary osteotomies for a mono-block advancement are completed. It is then necessary to mobilize the segments, but not to the extent required intraditional craniofacial surgery. The surgeon must becertain that the bone segment is free and mobile. Afterclosure, the adjustable halo system is placed as previouslydescribed.

After 3-7 days distraction is begun by activating the screwsin the horizontal bars at the rate of one millimeter per day(two 0.5 millimeter turns). As the clinician notices that theforehead is close to the anterior aspect of the cranial halo,the screws of the fixed part of the halo can be activated.It should be noted that the capability of linear distraction issubstantially increased. Activation of the screws in the halobase will result in advancement of the vertical bars, whichin turn will result in additional orbital and midfacialadvancement. Activation of the halo screws can be done at any time; but is usually initiated when the forehead tohalo distance is about 5-10 millimeters.

Vector control is achieved by differential activation of thedistraction screws mounted on the horizontal bars.Activation of the halo screws will maintain the angulation of the initial vectors of distraction.

Fig. 1

Removal of the RED is performed by simply looseningthe titanium fixation screws on both sides of the RED untilit can be gently lifted away from the cranium. In olderchildren and adults, this is performed in the clinic afteranesthetizing the skin immediately adjacent to eachtitanium fixation screw with a minimal amount of localanesthetic. In young children the RED can be removed inan outpatient setting under light sedation. Removal of theRED takes only the amount of time required to unscrewthe titanium fixation screws.

After removal of the screw there will be a small separationof the scalp at the location where the screw was removed.Any crusting at this site can be gently removed with analcohol swab or moistened gauze. No other care of thesesites is required after the removal of the RED. The patientcan wash their hair normally the same day as removal ofthe device and within 24-48 hours any small scalpseparations close.

Rigid External Distraction RED II SystemDiscussion

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1. Is a complete LeFort I osteotomy required or can I perform only amaxillary corticotomy?This is a key question. We highly recommend a complete LeFort I osteotomywith bilateral pterygomaxillary and septal disjunction. The maxillary segmentsshould also be mobilized, especially in patients with severe palatal/pharyngealscarring. In young children a high transverse osteotomy is necessary to avoidtooth buds.

2. How is the external distraction device tolerated by the patient, does it hurt?The rigid external distraction device (RED) is extremely well tolerated by thepatient. This device is lightweight, and there is virtually no discomfortexperienced with the titanium fixation screws. It does not hurt the patient andno pain medications are required. This is the same experience reported fordecades with the use of a cranial halo with neurosurgical and trauma patients.

3. What special care is required at the screw site while wearing thedevice?None. Patients should shampoo their hair and carry out normal scalp hygiene.No ointments, creams, or other medications should be applied at the screw site.

4. How active can the patient be while wearing the device?Patients can perform most normal daily activities with the exception of athletics,swimming and contact sports.

5. Do the patients experience pain during the distraction procedure orturning of the distraction screws?No, this process is pain free. This is the same experience reported withmandibular distraction.

6. Are the changes we see in these patients a true skeletal change or arethey dental?With the use of the intraoral appliance as described, all of the vertical,horizontal, and transverse movements which occur during the distractionprocedure are skeletal in nature. Rigid external distraction as described in thisbooklet produces no significant dental movements.1,2

7. How much control do you have over maxillary skeletal changes?The RED allows for excellent horizontal and vertical control over the maxillarymovements. The horizontal control is achieved through the activation of thedistraction screws. The vertical control is obtained by changing the position of the horizontal cross-bar which supports the distraction screws. Theseadjustments can be performed any time during the distraction process.

8. Do you see skeletal relapse with maxillary distraction osteogenesis?The answer so far to this question is no. 12 to 24 month follow-up has shown nosignificant vertical or horizontal relapse in patients who have undergone rigidexternal distraction of the maxilla.1,2 This is true irrespective of the number ofmaxillary segments involved during the osteotomy or age of the patient.

9. Do you need to overcorrect with rigid external distraction of themaxilla?In general, in fully grown patients, an overcorrection of the overjet in maxillarydistraction with the use of the RED is not required. Distraction with the REDshould be continued until the full amount of desired overjet and occlusal relationsare achieved. At this point the retention phase is begun. In growing children anovercorrection of the overjet by 2-4 mm beyond the desired maxillary positionshould be considered. If over-correction is contemplated care should be taken to finish the core with adequate and staple posterior occlusal relations.

COMMONQUESTIONS

REGARDING RIGIDEXTERNAL

DISTRACTION(RED)

COMMONQUESTIONS

REGARDING RIGIDEXTERNAL

DISTRACTION(RED)

COMMONQUESTIONS

REGARDING RIGIDEXTERNAL

DISTRACTION(RED)

Rigid External Distraction RED II SystemDiscussion

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10. How is the RED removed?Following completion of the distraction process and the period of rigid retention,the titanium fixation screws are simply unscrewed and the RED removed. Thiscan be performed in older children and adults with local anesthesia in the clinicsetting or with mild sedation in the younger age group.

11. Is any special care required at the site of the titanium fixation screwsfollowing removal of the device?No. Normal scalp hygiene is continued and the small separation of the skin atthis site closes within 24-48 hours.

12. Is maxillary distraction osteogenesis with rigid external distraction(RED) a definitive surgical procedure?In some patients if the occlusal relationships and dental arches are wellcoordinated prior to distraction, the distraction can be a definitive procedure.In other patients whose arches are not well coordinated, and in patients who arevery young, maxillary distraction with the RED is a very important intermediateprocedure which allows the surgeon to obtain substantial maxillaryadvancement with good alignment of the basal skeleton between the upper andlower jaws. For these patients a definitive LeFort I procedure may be indicatedat a later date to obtain final ideal occlusal relationships. However, the amount of vertical and horizontal change at the time of this definitive surgery should beminimal. This allows for total correction of the deficiency only in the affected jawand the additional bone stock from the distraction procedure enables maximumstability and minimal chance for relapse.

13. Can any orthodontist manufacture the intraoral appliance utilizedduring maxillary distraction?Yes. All of the supplies required to manufacture the appliance can be found inthe orthodontist’s office or laboratory. Most orthodontists are familiar with thebasic design of the appliance and how to manufacture it.

14. Can the patient eat and speak with the rigid external distraction (RED)device in place?Yes; however, it is imperative that the intraoral appliance be fabricated andplaced as specified in the orthodontic protocol of this manual. The day aftersurgery patients are placed on a soft diet and they gradually progress to aharder diet. The lip seal is not affected by the traction hooks thereforeswallowing and speech are not impaired. Remember intermaxillory fixation isnot used during the procedure.

15. Do you expect changes in the velopharyngeal mechanism?Any time that the maxilla is advanced the risk exists of affecting thevelopharyngeal mechanism. However, this effect is related to the amount ofdistraction performed. Patients with large anterior movements are more likely to experience velopharyngeal changes. In patients with a pharyngeal flap noalteration of the flap at the time of surgery is required. After distraction mostpatients report an improvement in speech articulation as the dental archesassume normal relations. Improved nasal patency has also been reported in previously obstructed patients.

Reference: The Journal of Craniofacial Surgery/Volume 10, Number 4 July 1999

COMMONQUESTIONS

REGARDING RIGIDEXTERNAL

DISTRACTION(RED)

Rigid External Distraction RED II SystemCase I

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A six-year old boy with the diagnosisof Apert’s Syndrome was scheduledfor monoblock advancement withdistraction utilizing the modified rigidexternal distraction device. Aftergeneral anesthesia, the previouslyprepared intraoral device wascemented and secured with circum-dental wires to as many teeth aspossible. After completing the bonycuts for monoblock osteotomy, theright and left superaorbital plateswith a thread for percutaneous pinswere secured with bone screws.After all the incisions were closed,the halo was secured utilizing thevertical bar as a guide for properfacial placement. Three skull screwswere utilized on each side. At thecompletion of an unremarkable 3 day hospital stay and prior todischarge, the vertical bar anddistraction screws were mounted and connected with surgical wire tothe supraorbital traction pins, and thetraction hooks of the intraoral splint.

On the fifth post-operative day,distraction was initiated at the rate ofone millimeter per day. After 15 mm.of distraction, it became necessary to activate the halo screws. This wasdone at the rate of one millimeter perday for five days. After a three-weekrigid consolidation period, the haloand traction pins and the intraoraldevice were removed under generalanesthesia. The total advancementwas 20 millimeters at the orbital level,and 18 millimeters at the dental level.

The exohtalmos, nasal bridgedepression, and severe anterior crossbite were successfully corrected.

Rigid External Distraction RED II SystemCase II

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This 5 year old boy with a repairedleft unilateral cleft lip and palate andsevere maxillary deficiency wastreated with maxillary distractionosteogenesis utilizing RED. The REDdevice was anchored with scalp pinsto the cranium providing the rigidanchorage required for controlledmaxillary distraction. The REDdevice is connected through surgicalwires to an intraoral appliancecemented and wired to the patient’steeth. The preoperative view revealsthe concave profile of the patient andthe retrusion of the maxilla relative tothe mandible and the anterior cranialbase. The intraoral viewdemonstrates complete anterior andposterior crossbites.

The patient underwent a high twopiece LeFort I maxillary osteotomy,with pterygomaxillary and septaldisjunction, avoiding all tooth buds.No internal fixation hardware orbone grafts were utilized.Immediately following completion ofthe osteotomy, RED was placed. Thepatient was discharged from thehospital the morning followingsurgery and maxillary distractionwas begun on the fifth postoperativeday at the rate of 1 mm per day.The patient underwent 11 mm ofmaxillary distraction utilizing RED.After distraction the concave defor-mity of the face was corrected tonormal facial relations and pro-portions. The postoperative intraoralview demonstrates correction of thecrossbites with stable occlusalrelations. The postoperative radio-graph demonstrates the markedincreased convexity of the skeletalprofile. The tracings demonstratethe extent of maxillary advancementwith minimal changes in mandibularposition. These changes are stableat 18 months following the distraction.

Rigid External Distraction RED II SystemCase III

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This 10 year 2 month old boypresented with a repaired bilateralcleft lip and palate with severescarring of the soft tissues andsevere maxillary hypoplasia.The preoperative photographsrevealed the extreme retrusion of the midface and upper lip.The preoperative lateral cephalo-metric radiograph revealed severemaxillary hypoplasia with a cross-bite of 16 mm and mandibularoverclosure.

The patient underwent a high threepiece LeFort I maxillary osteotomywith pterygomaxillary and septaldisjunctions, and completemobilization of the premaxillawithout bone grafting. No internalfixation hardware was utilized.The RED device was placedimmediately following completion of the osteotomy. The patient wasdischarged from the hospital themorning after surgery.On postoperative day 6, distractionwas begun at the rate of 1 mm perday. The total maxillary advance-ment was 16 mm. The improvementof the facial profile and vertical facialdimensions are evident in the facialpostoperative photographs.The postoperative cephalometricradiograph demonstrates adequatemaxillo-mandibular relationships andimproved overjet. The skeletalchanges are also highlighted on the tracings in which the maxillaryadvancement is clearly noted.During the distraction process therewas also a slight mandibular rotationin the counterclockwise direction.After 2 years the patient hasremained stable with no evidence of relapse.

Rigid External Distraction RED II SystemCase IV

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This 9 year 10 month old boy with a repaired left unilateral cleft lip andpalate presented with severemaxillary hypoplasia.The preoperative facial photographsdemonstrate the midface deficiencywith a concave profile and retrusiveupper lip. Intraorally there weremarked anterior and bilateralposterior crossbites.

The patient underwent a high twopiece LeFort I osteotomy withpterygomaxillary and septaldisjunctions. No bone grafting orrigid internal fixation hardware wasutilized. There was no repositioningof the maxilla at the time of thesurgery. The RED device wasplaced immediately after theosteotomy and the patient wasdischarged the morning aftersurgery. Distraction was initiated on postoperative day 5 at the rate of 1 mm per day. The total maxillaryadvancement was 10 mm. Threeweeks of rigid retention wereutilized. After maxillary distractionthe facial profile and balance wererestored to normal proportions.Note the improved prominence atthe malar level and the improvedrelationship between the upper andlower lips. Nasal form was alsoimproved as a result of the maxillaryadvancement through distractionosteogenesis. The postoperativeintraoral photographs demonstratecomplete correction of the anteriorcrossbite. One year after distractionthe patient has not shown signs ofrelapse.

Rigid External Distraction RED II SystemCase V

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The patient is a 20-year old femalewith severe congenital craniofacialmalformation consistent with thediagnosis of cleidocranial dysostosis.

Past surgical history has involvedmultiple leg osteotomies for conco-mitant stigmata associated with hercongenital deformity. She presentedwith severe maxillary horizontal andvertical hypoplasia and multiple mal-formed and impacted permanent anddeciduous teeth.

The patient underwent the subcra-nial LeFort III osteotomy, multipleapproaches, utilizing both a subcon-junctival incision bilaterally as well asan intra-oral approach to completethe necessary osteotomies.

The challenge was a severe hypopla-sia of both orbital rims and the zygo-maticomaxillary complex area bilate-rally. The case success was greatlyfacilitated through the availability of a 3-dimensional model that had beenfabricated from the CT scan. Aftercompletion of the subcranial LeFort IIIosteotomies, the RED halo and dis-traction device were applied and theinitial distraction was activated.

The patient was then allowed to bewithout any further distraction in aquiescent period for 7 days, at whichpoint we started the distraction inboth an AP and vertical direction.The patient was extremely compliantand without pain throughout thisperiod and was seen on a daily basisto complete the activations. A total of22 days were used for active distrac-tion, at which point we entered thestabilization phase and allowed onlyintermaxillary elastic rubber bands to be used on a daily basis, withoutfurther activation of the RED halodevice itself. After completion of theretention period, the halo was remo-ved. The patient was now placed into continuing intermaxillary elasticsin order to facilitate stabilization andcircumvent relapse.

Clinical photos courtesy of Mirage Center for Oral andMaxillofacial SurgeryRancho Mirage, CA

All other clinical photos courtesy ofDr. John Polley, M.D. and

Dr. Alvaro Figueroa, D.D.S., M.S.

Throughout the preoperative, intra-operative and postoperative course,the patient has been extremelycompliant and without significantpain. In the AP direction, a total of17.5mm of distraction was achieved.In the vertical dimension, a total of9.5mm were achieved without anyrelapse observed during the 6-monthfollow-up cephalometric tracings.

18

Rigid External Distraction RED II System

When I first heard that my only safest and best option

would be to wear the RED device for 6 weeks, I was

devastated. However, I told the doctors that day, that I

would go ahead with the surgery. I had known this day

would come for 15 years, but did not know how they

were going to pull the jaw out, just that I would need to

have it done. Before the surgery I had very low self-

esteem, could not breath through my nose, and I could

not chew food normally. The pain afterwards was

surprisingly tolerable and the only real discomfort was

a little pressure, and a feeling of stretching when they

were distracting the jaw. However, it would only last a

short time. It is not as bad as it may seem, as long as

you have support from family and friends, and most of all

you have the want for the results of the surgery. I can

now chew, bite, breath through my nose, and have a

higher self esteem. I would not change this experience

and I look forward to the end results.

Sincerely,

Brett

P.S. ... Thank you again for everything that this

product can do for me as well as others. It's truly a great

creation.

BRETT’S EXPERIENCE

19

Rigid External Distraction RED II SystemLiterature

1)Polley, J.W., Figueroa, AA.: Management of Severe Maxillary Deficiency in Childhood and Adolescence throughDistraction Osteogenesis with an External, Adjustable, Rigid Distraction Device. The Journal of Craniofacial Surgery, 8, (3)181-185, May 1997.

2)Polley, J.W., Figueroa, AA.: The Management of Cleft Maxillary Hypoplasia with (RED) Rigid External Distraction.Proceedings of the International Congress on Distraction Osteogenesis of the Facial and Cranial Bones. Paris, France June19 – 21, 1997. 255-260.

3)Polley, J.W., Figueroa, AA., Hong, KF., Huang, CS,: Distraction Osteogenesis in the Treatment of Cleft MaxillaryDeformities. Plastic Surgical Forum XX 127-131, 1997.

4)Polley, J.W., Figueroa, AA. Midface Osteodistraction-Commentary on Midface Advancement by Bone Distraction andDistraction Osteogenesis and its Application to the Midface and Bony Orbit in the Craniosynostosis Syndromes. TheJournal of Craniofacial Surgery. 9, (2) 119-122, March 1998.

5)Polley, J.W., Figueroa, AA. Rigid External Distraction (RED): It’s application in cleft maxillary deformities. The Journal ofPlastic and Reconstructive Surgery, 102 (5). 1360-1372. October 1998.

6)Polley, J.W., Ko, E.W., Figueroa, A.A., Guyette, T.W., Law, W.R. Velopharyngeal Changes After Maxillary Advancement inCleft Patients with Distraction Osteogenesis Using a Rigid External Distraction Device: A 1-Year Cephalometric Follow-up.The Journal of Craniofacial Surgery, 1999; 10:4:312-320.

7)Polley, J.W. Commentary on Maxillary Distraction in Cleft Lip Palate Patients: A Review of Six Cases. The Journal ofCraniofacial Surgery, 1999: 10:4:329.

8)Polley, J.W., Figueroa, A.A. Maxillary Distraction Osteogenesis with Rigid External Distraction. Atlas of the Oral andMaxillofacial Surgery Clinics of North America, 1999; Volume 7:1.

9)Figueroa AA, Polley JW: Orthodontic procedure for maxillary distraction. In International Congress on Cranial andFacial Bone Distraction Processes.

10)Figueroa, AA, Polley, JW. Management of severe cleft maxillary deficiency with distraction Osteogenesis: Procedureand Results. Amer. J. Orthod. Dentofacacial Orthop., 1999; 115-1-12.

11)Figueroa, AA, Polley, JW, Ko, EW-C. Maxillary distraction for the management of cleft maxillary hypoplasia with a rigidexternal distraction system. Seminars in Orthodontics, 1999; 5: 46-51.

12)Ko, EW, Figueroa AA, Guyette, TW, Polley JW, Law, WR. Velopharyngeal changes after maxillary advancement in cleftpatients with distraction Osteogenesis using a rigid external distraction device: A 1-year cephalometric follow-up. JourCraniofac Surg, 1999; 10:312-320.

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