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 from KLS-Martin demonstrates dramatic distraction results in patients with a wide variety of maxillary and midface hypoplasias. When utilized properly this system, developed by KLS-Martin, provides an essential modality for patients with severe midface deficiencies.

Common Questions Regarding Rigid External Distraction (RED)

Is a complete LeFort I osteotomy required or can I perform 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.
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.
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.
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.
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.
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.
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.
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. This is true irrespective of the number of maxillary segments involved during the osteotomy or age of the patient.
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 to 4 mm beyond the desired maxillary position should be considered.
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.
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 24 to 48 hours.
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.
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.
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.
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.

**Clinical Case**
	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.