Osteodistraction. Rigid External Distraction RED II System

Transcription

1 Osteodistraction Rigid External Distraction RED II System

2 Rigid External Distraction RED II System Clinical example: LeFort I region Clinical example: LeFort III region 2

3 Introduction 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. 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. Ability to treat severe deformities with minimal associated morbidity and at reduced cost. No bone grafting or internal fixation devices required. 3

4 Placement of the RED System Step by Step Instructions 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) Fig. 1 Fig. 2 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. Fig. 3 6 Additional Considerations 1. No prepping of the scalp is required. Have the patient shampood their hair the night before surgery. No shaving of the hair at the screw site is required. For patients with very long hair, have an assistant hold the hair out of the way while placing titanium fixation screws to prevent entanglement. 2. No postoperative care of the screw site is required. The patient may shampoo and dry their hair normally with the RED in place. 3. Temporary placement of the vertical bar at the time of placement of the RED is helpful in orienting cranial and facial midlines, as well as distance to the face. 4. After placement of the RED, the vertical bar and horizontal cross-bar are generally removed and replaced postoperatively on the date of initiation of distraction. 5. A minimum of 2 titanium fixation screws per side are required to secure the RED. Three titanium fixation screws per side is preferred. The tightness of the titanium fixation screws can be checked with the torque wrench at any time during the postoperative period in the clinic. 6. In patients with prior craniotomies palpate the skull prior to screw placement to be certain that there is solid bone under the scalp at the location where you want to place the titanium fixation screw.

5 Distraction Protocol Step by Step Instructions Distraction Initiation Following discharge from the hospital (usually 24 hours after surgery) the patient returns to the office on the 4th or 5th postoperative day for follow-up. At this time the 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 revolution of 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. During this time adjustments in the rate of distraction can be made based upon clinical judgement. Adjustments in the position of the horizontal cross-bar in the vertical dimension can be made in the clinic. This allows for changes in the vector of distraction depending on the clinical requirements. Rotations of the occlusal plane can be controlled by adjusting the vertical position of the horizontal cross-bar and/or by rotation of the spindle units containing the distraction screws. This may be done at any time during the distraction process. These adjustments are performed readily in the clinic with no patient discomfort. With the RED system an unlimited amount of horizontal distraction can be performed. If the distraction screws have reached a maximum level of advancement, the surgical wires connecting the distraction screws and the traction 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 2-3 weeks to allow for rigid retention. The RED is then removed and an additional 4-6 weeks of nighttime elastic retention is utilized with a standard orthodontic face mask. The extraoral traction hooks of the intraoral appliance are cut at the time of removal of the RED and the elastic retention performed at nighttime only is done through use of the intraoral hooks previously built into the appliance. 7

6 Intraoral Splint Step by Step Instructions Fig. 1 In order to apply traction to the maxilla through the dentition, a rigid intraoral splint needs to be fabricated. Orthodontic bands with inch headgear tubes are fitted either on the second primary molars (children under 6 years) or first permanent molars and an alginate or compound impression is taken of the maxillary arch. The bands are transferred and the impression is poured with dental stone. The splint is made on the working model, with or stainless steel rigid orthodontic wire. If the patient does not have orthodontic brackets, the labial and palatal wires are bent in close contact with most of the maxillary teeth. If the patient has orthodontic brackets, the labial wire has to be bent outward and gingivally to clear the existing appliances. If needed, a transpalatal bar can be added to increase rigidity. Connecting wires between the labial and palatal arches through the embrasures between the lateral and canine teeth bilaterally or in any other area where the wire can be passed without interfering with the occlusion may also be incorporated (Fig. 1). Fig. 2 The basic design of the splint has been successfully used in patients undergoing protractive 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 medial to both commissures. The splint is removed from the patient s mouth and two straight pieces of inch rigid stainless steel orthodontic wire are soldered perpendicular to the labial wire. (Fig. 2) These vertical wires have a short end towards the vestibule that eventually will be used as intraoral hooks. The long end of the vertical wire is marked while the device is in the mouth to bend the external traction hooks. The wire is bent under, over and anterior to the lip. The ends of the wire are bent in a circle to eliminate sharp ends and to have a rigid eyelet from where to apply the traction. This traction eyelet is positioned at the level of the floor of the nose or at any other desired level to control rotational movements of the maxilla (Fig. 3). The purpose of this external hook is to avoid any irritation to the lip while applying traction and also to control the direction of the 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 or surgery, circumdental wires are passed through most of the maxillary teeth to increase rigidity and stability (Fig. 4, 5). Fig. 3 In certain instances, it becomes necessary to do an intraoral splint to an abnormal arch form, knowing that after distraction, the patient will undergo further orthodontic treatment or surgical orthodontic expansion of the arch. If it is determined that the arch will be expanded surgically at the time of the required osteotomy for distraction, the cast has to be cut, aligned, and the splint made to the newly desired maxillary arch form. Fig. 4 8

7 Intraoral Splint Step by Step Instructions It is preferable to do arch expansion procedures before or after maxillary distraction to avoid moving the maxillary bone simultaneously in several directions where vector control can become more difficult. If the clinician desires to expand simultaneously with anterior distraction, an expansion screw can 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 orthodontic headgear 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 are passed through the headgear tubes for future soldering. The outer bow is bent downward and anteriorly, in order to clear the upper lip. The advantage of using a face bow is that the wires for the traction hooks (outer bow) are strong and rigid and the traction hooks are already soldered (Fig. 7). It is difficult to use the face bow in maxillary arches with poor arch form or in young children because it is difficult to adapt the inner bow to the teeth, making circumdental wiring difficult. Fig. 5 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 be cemented after the patient is anesthetized and before surgical preparation in the operating room. In cases in which a splint has been made to a surgically created arch form, the splint has to be cemented after the maxillary osteotomy is completed and the segments have been mobilized. This procedure can be difficult, as the segments are mobile and maintaining a dry field can be difficult. Adequate assistance from the surgeon and assisting personnel are required to hold the segments in place and maintain a dry field. Fig. 6 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 with long external outer bow. Fig. 7 Figure 7 Completed intraoral appliance made from a headgear face bow. The outer bow has been bent to form the traction hooks. Note small soldered hooks to be used during the facial mask retention phase after distraction. Figure 8 Reinforced External Traction Hook Fig. 8 9

8 LeFort II, III, Monoblock Procedures Modification for Monoblock Advancement: During Monoblock advancement, the orbital-maxillofacial complex is mobilized and advanced. If a fixed halo is utilized for distraction, the advancement is limited by the fixed position of the halo. Thus, the surgeon must place the halo sufficiently forward to provide enough space for advancement or risk having to reposition the halo with a subsequent operation. This represents additional morbidity to an otherwise straightforward and minimally invasive procedure. To avoid the two previously mentioned limitations of the technique, the fixed cranial halo has been modified to be adjustable. The device consists of a base with screw perforations for fixation. The superior and posterior part of the base contains a stop through which an activating screw has been added. The anterior part of the screw extends into a movable part, which slides above the fixed base. (figure 1) This adjustability allows the surgeon to advance the anterior part of the cranial halo as the advancing supraorbital rims approximate the halo. To provide control of the monoblock segment during advancement, and to adjust the vectors of distraction, two levels of anchorage to the moving segments are utilized. A superior one connected to specially designed plates over the supraorbital rims and percutaneous pins that exit through the eyebrows. This allows for a hidden scar. The inferior anchorage for the advancement is provided by two traction hooks anchored to an intraoral appliance. Superior and inferior horizontal bars are utilized. Each horizontal bar has a right and left distraction screw. The distraction screws are connected to the superior traction pins and to the dentally anchored traction hooks utilizing surgical wire gauge 26. Fig. 1 Distraction Protocol: After careful preoperative planning the distraction vectors are planned. All the necessary osteotomies for a monoblock advancement are completed. It is then necessary to mobilize the segments, but not to the extent required in traditional craniofacial surgery. The surgeon must be certain that the bone segment is free and mobile. After closure, the adjustable halo system is placed as previously described. After 3-7 days distraction is begun by activating the screws in the horizontal bars at the rate of one millimeter per day (two 0.5 millimeter turns). As the clinician notices that the forehead 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 is substantially increased. Activation of the screws in the halo base will result in advancement of the vertical bars, which in turn will result in additional orbital and midfacial advancement. Activation of the halo screws can be done at any time; but is usually initiated when the forehead to halo distance is about 5-10 millimeters. Vector control is achieved by differential activation of the distraction screws mounted on the horizontal bars. Activation of the halo screws will maintain the angulation of the initial vectors of distraction. Removal of RED Step by Step Instructions Removal of the RED is performed by simply loosening the titanium fixation screws on both sides of the RED until it can be gently lifted away from the cranium. In older children and adults, this is performed in the clinic after anesthetizing the skin immediately adjacent to each titanium fixation screw with a minimal amount of local anesthetic. In young children the RED can be removed in an outpatient setting under light sedation. Removal of the RED takes only the amount of time required to unscrew the titanium fixation screws. After removal of the screw there will be a small separation of the scalp at the location where the screw was removed. Any crusting at this site can be gently removed with an alcohol swab or moistened gauze. No other care of these sites is required after the removal of the RED. The patient can wash their hair normally the same day as removal of the device and within hours any small scalp separations close. 10

9 Discussion 1. Is a complete LeFort I osteotomy required or can I perform only a maxillary corticotomy? This is a key question. We highly recommend a complete LeFort I osteotomy with bilateral pterygomaxillary and septal disjunction. The maxillary segments should also be mobilized, especially in patients with severe palatal/pharyngeal scarring. In young children a high transverse osteotomy is necessary to avoid tooth 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 the patient. This device is lightweight, and there is virtually no discomfort experienced with the titanium fixation screws. It does not hurt the patient and no pain medications are required. This is the same experience reported for decades with the use of a cranial halo with neurosurgical and trauma patients. 3. What special care is required at the screw site while wearing the device? 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. COMMON QUESTIONS REGARDING RIGID EXTERNAL DISTRACTION (RED) 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 or turning of the distraction screws? No, this process is pain free. This is the same experience reported with mandibular distraction. 6. Are the changes we see in these patients a true skeletal change or are they dental? With the use of the intraoral appliance as described, all of the vertical, horizontal, and transverse movements which occur during the distraction procedure are skeletal in nature. Rigid external distraction as described in this booklet 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 maxillary movements. The horizontal control is achieved through the activation of the distraction screws. The vertical control is obtained by changing the position of the horizontal cross-bar which supports the distraction screws. These adjustments 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 no significant vertical or horizontal relapse in patients who have undergone rigid external distraction of the maxilla. 1,2 This is true irrespective of the number of maxillary segments involved during the osteotomy or age of the patient. 9. Do you need to overcorrect with rigid external distraction of the maxilla? In general, in fully grown patients, an overcorrection of the overjet in maxillary distraction with the use of the RED is not required. Distraction with the RED should be continued until the full amount of desired overjet and occlusal relations are achieved. At this point the retention phase is begun. In growing children an overcorrection of the overjet by 2-4 mm beyond the desired maxillary position should be considered. If over-correction is contemplated care should be taken to finish the core with adequate and staple posterior occlusal relations. 11

10 Discussion COMMON QUESTIONS REGARDING RIGID EXTERNAL DISTRACTION (RED) 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. This can be performed in older children and adults with local anesthesia in the clinic setting or with mild sedation in the younger age group. 11. Is any special care required at the site of the titanium fixation screws following removal of the device? No. Normal scalp hygiene is continued and the small separation of the skin at this site closes within 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 well coordinated prior to distraction, the distraction can be a definitive procedure. In other patients whose arches are not well coordinated, and in patients who are very young, maxillary distraction with the RED is a very important intermediate procedure which allows the surgeon to obtain substantial maxillary advancement with good alignment of the basal skeleton between the upper and lower jaws. For these patients a definitive LeFort I procedure may be indicated at 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 be minimal. This allows for total correction of the deficiency only in the affected jaw and the additional bone stock from the distraction procedure enables maximum stability and minimal chance for relapse. 13. Can any orthodontist manufacture the intraoral appliance utilized during maxillary distraction? Yes. All of the supplies required to manufacture the appliance can be found in the orthodontist s office or laboratory. Most orthodontists are familiar with the basic 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 and placed as specified in the orthodontic protocol of this manual. The day after surgery patients are placed on a soft diet and they gradually progress to a harder diet. The lip seal is not affected by the traction hooks therefore swallowing and speech are not impaired. Remember intermaxillory fixation is not 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 the velopharyngeal mechanism. However, this effect is related to the amount of distraction performed. Patients with large anterior movements are more likely to experience velopharyngeal changes. In patients with a pharyngeal flap no alteration of the flap at the time of surgery is required. After distraction most patients report an improvement in speech articulation as the dental arches assume normal relations. Improved nasal patency has also been reported in previously obstructed patients. Reference: The Journal of Craniofacial Surgery/Volume 10, Number 4 July

11 Case I A six-year old boy with the diagnosis of Apert s Syndrome was scheduled for monoblock advancement with distraction utilizing the modified rigid external distraction device. After general anesthesia, the previously prepared intraoral device was cemented and secured with circumdental wires to as many teeth as possible. After completing the bony cuts for monoblock osteotomy, the right and left superaorbital plates with a thread for percutaneous pins were secured with bone screws. After all the incisions were closed, the halo was secured utilizing the vertical bar as a guide for proper facial placement. Three skull screws were utilized on each side. At the completion of an unremarkable 3 day hospital stay and prior to discharge, the vertical bar and distraction screws were mounted and connected with surgical wire to the supraorbital traction pins, and the traction hooks of the intraoral splint. On the fifth post-operative day, distraction was initiated at the rate of one millimeter per day. After 15 mm. of distraction, it became necessary to activate the halo screws. This was done at the rate of one millimeter per day for five days. After a three-week rigid consolidation period, the halo and traction pins and the intraoral device were removed under general anesthesia. The total advancement was 20 millimeters at the orbital level, and 18 millimeters at the dental level. The exohtalmos, nasal bridge depression, and severe anterior cross bite were successfully corrected. 13

12 Case II This 5 year old boy with a repaired left unilateral cleft lip and palate and severe maxillary deficiency was treated with maxillary distraction osteogenesis utilizing RED. The RED device was anchored with scalp pins to the cranium providing the rigid anchorage required for controlled maxillary distraction. The RED device is connected through surgical wires to an intraoral appliance cemented and wired to the patient s teeth. The preoperative view reveals the concave profile of the patient and the retrusion of the maxilla relative to the mandible and the anterior cranial base. The intraoral view demonstrates complete anterior and posterior crossbites. The patient underwent a high two piece LeFort I maxillary osteotomy, with pterygomaxillary and septal disjunction, avoiding all tooth buds. No internal fixation hardware or bone grafts were utilized. Immediately following completion of the osteotomy, RED was placed. The patient was discharged from the hospital the morning following surgery and maxillary distraction was begun on the fifth postoperative day at the rate of 1 mm per day. The patient underwent 11 mm of maxillary distraction utilizing RED. After distraction the concave deformity of the face was corrected to normal facial relations and proportions. The postoperative intraoral view demonstrates correction of the crossbites with stable occlusal relations. The postoperative radiograph demonstrates the marked increased convexity of the skeletal profile. The tracings demonstrate the extent of maxillary advancement with minimal changes in mandibular position. These changes are stable at 18 months following the distraction. 14

13 Case III This 10 year 2 month old boy presented with a repaired bilateral cleft lip and palate with severe scarring of the soft tissues and severe maxillary hypoplasia. The preoperative photographs revealed the extreme retrusion of the midface and upper lip. The preoperative lateral cephalometric radiograph revealed severe maxillary hypoplasia with a crossbite of 16 mm and mandibular overclosure. The patient underwent a high three piece LeFort I maxillary osteotomy with pterygomaxillary and septal disjunctions, and complete mobilization of the premaxilla without bone grafting. No internal fixation hardware was utilized. The RED device was placed immediately following completion of the osteotomy. The patient was discharged from the hospital the morning after surgery. On postoperative day 6, distraction was begun at the rate of 1 mm per day. The total maxillary advancement was 16 mm. The improvement of the facial profile and vertical facial dimensions are evident in the facial postoperative photographs. The postoperative cephalometric radiograph demonstrates adequate maxillo-mandibular relationships and improved overjet. The skeletal changes are also highlighted on the tracings in which the maxillary advancement is clearly noted. During the distraction process there was also a slight mandibular rotation in the counterclockwise direction. After 2 years the patient has remained stable with no evidence of relapse. 15

14 Case IV This 9 year 10 month old boy with a repaired left unilateral cleft lip and palate presented with severe maxillary hypoplasia. The preoperative facial photographs demonstrate the midface deficiency with a concave profile and retrusive upper lip. Intraorally there were marked anterior and bilateral posterior crossbites. The patient underwent a high two piece LeFort I osteotomy with pterygomaxillary and septal disjunctions. No bone grafting or rigid internal fixation hardware was utilized. There was no repositioning of the maxilla at the time of the surgery. The RED device was placed immediately after the osteotomy and the patient was discharged the morning after surgery. Distraction was initiated on postoperative day 5 at the rate of 1 mm per day. The total maxillary advancement was 10 mm. Three weeks of rigid retention were utilized. After maxillary distraction the facial profile and balance were restored to normal proportions. Note the improved prominence at the malar level and the improved relationship between the upper and lower lips. Nasal form was also improved as a result of the maxillary advancement through distraction osteogenesis. The postoperative intraoral photographs demonstrate complete correction of the anterior crossbite. One year after distraction the patient has not shown signs of relapse. 16

15 Case V The patient is a 20-year old female with severe congenital craniofacial malformation consistent with the diagnosis of cleidocranial dysostosis. Past surgical history has involved multiple leg osteotomies for concomitant stigmata associated with her congenital deformity. She presented with severe maxillary horizontal and vertical hypoplasia and multiple malformed and impacted permanent and deciduous teeth. The patient underwent the subcranial LeFort III osteotomy, multiple approaches, utilizing both a subconjunctival incision bilaterally as well as an intra-oral approach to complete the necessary osteotomies. The challenge was a severe hypoplasia of both orbital rims and the zygomaticomaxillary complex area bilaterally. The case success was greatly facilitated through the availability of a 3-dimensional model that had been fabricated from the CT scan. After completion of the subcranial LeFort III osteotomies, the RED halo and distraction device were applied and the initial distraction was activated. The patient was then allowed to be without any further distraction in a quiescent period for 7 days, at which point we started the distraction in both an AP and vertical direction. The patient was extremely compliant and without pain throughout this period and was seen on a daily basis to complete the activations. A total of 22 days were used for active distraction, at which point we entered the stabilization phase and allowed only intermaxillary elastic rubber bands to be used on a daily basis, without further activation of the RED halo device itself. After completion of the retention period, the halo was removed. The patient was now placed into continuing intermaxillary elastics in order to facilitate stabilization and circumvent relapse. Throughout the preoperative, intraoperative and postoperative course, the patient has been extremely compliant and without significant pain. In the AP direction, a total of 17.5mm of distraction was achieved. In the vertical dimension, a total of 9.5mm were achieved without any relapse observed during the 6-month follow-up cephalometric tracings. Clinical photos courtesy of Mirage Center for Oral and Maxillofacial Surgery Rancho Mirage, CA All other clinical photos courtesy of Dr. John Polley, M.D. and Dr. Alvaro Figueroa, D.D.S., M.S. 17

16 BRETT S EXPERIENCE 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 selfesteem, 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. 18

17 Literature 1)Polley, J.W., Figueroa, AA.: Management of Severe Maxillary Deficiency in Childhood and Adolescence through Distraction Osteogenesis with an External, Adjustable, Rigid Distraction Device. The Journal of Craniofacial Surgery, 8, (3) , May )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 June 19 21, )Polley, J.W., Figueroa, AA., Hong, KF., Huang, CS,: Distraction Osteogenesis in the Treatment of Cleft Maxillary Deformities. Plastic Surgical Forum XX , )Polley, J.W., Figueroa, AA. Midface Osteodistraction-Commentary on Midface Advancement by Bone Distraction and Distraction Osteogenesis and its Application to the Midface and Bony Orbit in the Craniosynostosis Syndromes. The Journal of Craniofacial Surgery. 9, (2) , March )Polley, J.W., Figueroa, AA. Rigid External Distraction (RED): It s application in cleft maxillary deformities. The Journal of Plastic and Reconstructive Surgery, 102 (5) October )Polley, J.W., Ko, E.W., Figueroa, A.A., Guyette, T.W., Law, W.R. Velopharyngeal Changes After Maxillary Advancement in Cleft Patients with Distraction Osteogenesis Using a Rigid External Distraction Device: A 1-Year Cephalometric Follow-up. The Journal of Craniofacial Surgery, 1999; 10:4: )Polley, J.W. Commentary on Maxillary Distraction in Cleft Lip Palate Patients: A Review of Six Cases. The Journal of Craniofacial Surgery, 1999: 10:4:329. 8)Polley, J.W., Figueroa, A.A. Maxillary Distraction Osteogenesis with Rigid External Distraction. Atlas of the Oral and Maxillofacial Surgery Clinics of North America, 1999; Volume 7:1. 9)Figueroa AA, Polley JW: Orthodontic procedure for maxillary distraction. In International Congress on Cranial and Facial Bone Distraction Processes. 10)Figueroa, AA, Polley, JW. Management of severe cleft maxillary deficiency with distraction Osteogenesis: Procedure and Results. Amer. J. Orthod. Dentofacacial Orthop., 1999; )Figueroa, AA, Polley, JW, Ko, EW-C. Maxillary distraction for the management of cleft maxillary hypoplasia with a rigid external distraction system. Seminars in Orthodontics, 1999; 5: )Ko, EW, Figueroa AA, Guyette, TW, Polley JW, Law, WR. Velopharyngeal changes after maxillary advancement in cleft patients with distraction Osteogenesis using a rigid external distraction device: A 1-year cephalometric follow-up. Jour Craniofac Surg, 1999; 10:

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