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OBJECTIVE: To present information regarding the current federal regulation of cranial orthotics used for the treatment of deformational plagiocephaly as well as to discuss concerns raised by the Food and Drug Administration regarding the safety and effectiveness of these devices. BACKGROUND: Although first introduced in 1979, the use of orthotic helmets for the treatment of deformational plagiocephaly was slow to gain acceptance. However, with the recent increase in infants presenting with this condition, numerous orthotic treatment programs have been established throughout the country. Until recently, federal regulation of this "industry" was largely ignored. REGULATION: In 1995 our office was served notice that our orthosis would require clearance from the FDA. Since the FDA had never approved a medical device of this kind, clearance presented a significant challenge. However, after 3 years of providing clinical data, clearance was finally granted, and a new device category known generically as "cranial orthosis" was created. A cranial orthosis is considered to be a Class II neurology device and requires both general and special controls in order to ensure its safety and effectiveness. SUMMARY: Orthotics used for the treatment of deformational plagiocephaly are regulated by the FDA and are considered Class II neurology devices. Submission of a premarket notification (510[k]) is required prior to placing these devices on the market.

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The Dynamic Orthotic Cranioplasty Band is a cranial orthotic device used to treat deformational plagiocephaly in infants. The device works by applying a mild holding pressure to the most anterior and posterior prominences, where growth is not desired, while encouraging growth in adjacent flattened regions. Although this technique has been successfully used to treat infants as young as 3 months of age, it is often assumed that decreasing cranial growth and increasing cranial rigidity prohibit treatment in infants older than 1 year of age. The authors' experience with older infants suggests the contrary. Through a series of case reports, they present evidence that this treatment remains viable during the 2nd year of life and that improvement has been observed in infants in whom treatment has been initiated as late as 18 months. These examples certainly suggest that additional prospective studies are warranted.

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OBJECTIVES: The Dynamic Orthotic Cranioplasty (DOC) Band(TM) is a cranial orthosis used to treat deformational plagiocephaly. The ability of this device to redirect growth and thus, improve craniofacial asymmetry has raised concerns regarding the potential restriction of cranial growth. The purpose of this study was to evaluate the growth of the head during correction of plagiocephaly. METHODS: The study sample consisted of 190 children: 81 females (42. 6%) and 109 males (57.4%) All patients had been diagnosed with nonsynostotic plagiocephaly, did not have other significant medical conditions, were compliant with DOC protocol, and had complete anthropometric measurements at entrance and exit from treatment. Growth of the head was evaluated using head circumference, maximum cranial width and maximum cranial length. Correction of plagiocephaly was evaluated by documenting the reduction of craniofacial asymmetry of the cranial vault, skull base and face. Paired t tests were used to assess the significance of changes in these anthropometric measurements. Differences were considered significant if p < 0.05. RESULTS: Average entrance age was 6.5 months with a mean treatment time of 4.1 months. Statistical analysis demonstrated highly significant reductions in asymmetry in all three regions (p < 0.001). More importantly, these corrections were achieved with synchronous growth of the skull as demonstrated by highly significant increases (p < 0.001) in head circumference, maximum cranial width and maximum cranial length. CONCLUSIONS: These findings document statistically significant increases in cranial growth in association with concomitant reductions of the cranial asymmetries associated with deformational plagiocephaly.

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OBJECTIVE: The purpose of this study was to investigate the existence of sternocleidomastoid (SCM) imbalance in a plagiocephalic population and further clinically describe its difference, if any, from congenital muscular torticollis (CMT). If SCM imbalance is different from CMT, then the development of terminology and a differential diagnosis may allow early recognition and intervention and possible prevention of positional plagiocephaly in the first place. DESIGN: This was a retrospective, random review of 100 patients referred for orthotic correction of their positional plagiocephaly. SETTING: The data was collected in a private orthotic clinic and was directed by a physical therapist. The patients were seen on a weekly or biweekly basis. PATIENTS: Eighty-three patients diagnosed with positional plagiocephaly that were referred for Dynamic Orthotic Cranioplasty during 1996 were studied. RESULTS: Sixty-four percent of the sample was identified as having SCM imbalance and 12% was diagnosed with CMT. There were no statistically significant differences between the characteristics of these two groups in relation to the etiological factors of positional plagiocephaly. The only observed difference was related to symptoms of the neck itself. CONCLUSIONS: Seventy-six percent of the sample was found to have some degree of SCM dysfunction, whether it be SCM imbalance or CMT. The finding that over three quarters of our population suffers from some form of SCM dysfunction, either SCM imbalance or CMT, suggests that any degree of SCM dysfunction may act as a precursor to positional plagiocephaly and therefore should be recognized and treated at the earliest opportunity.

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OBJECTIVES: Infants with positional plagiocephaly often exhibit complex multistructural asymmetries that affect the face and skull base as well as the cranial vault. Dynamic Orthotic Cranioplasty (DOC) was developed as a nonsurgical alternative for the treatment of positional plagiocephaly. The effectiveness of DOC has been discussed elsewhere. The purpose of this study was to assess the influence of factors such as entrance age, treatment time, and initial severity on the effectiveness of correction. METHODS: The study sample consisted of 258 children with cranial vault asymmetry (CVA) treated prior to 1 year of age. In addition, 246 patients (92%) exhibited concurrent skull base (SBA) and orbitotragial depth (OTDA) asymmetries. All patients had been diagnosed with nonsynostotic plagiocephaly, did not have other contributing medical conditions, were compliant with DOC protocol, and had complete anthropometric measurements at entrance and exit from treatment. RESULTS: Mean age at start of treatment was 6.5 (+/-1.9) months (range, 2.8 to 11.0 months), with an average treatment time of 4.1 (+/-2.2) months. The effects of the treatment variables were analyzed using three-way analysis of variance. As expected, initial severity was significantly associated with the amount of correction (p = .0001). However, treatment time was not significant (p > .05). Most importantly, the analysis revealed that, having accounted for initial severity, entrance age had a statistically significant effect [F(1,254) = 8.36, p = .0042] on the correction of CVA. Similar results were identified for both the SBA [F(1,254) = 5.53, p = .0195] and the OTDA [F(1,254) = 5.22, p = .0231] asymmetries. CONCLUSIONS: These findings support clinical observations that earlier intervention results in significantly improved treatment of plagiocephaly, independent of the severity of the presenting asymmetries.

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OBJECTIVE: Deformational plagiocephaly refers to the development of an abnormal head shape in infants resulting from externally applied molding forces, which may occur either prenatally or postnatally. We have observed that an unexpectedly high number of multiple-birth infants have presented to our center with this condition. The purposes of this investigation were to: 1) determine the significance of this observation; and 2) examine the risk factors that may make this population more susceptible to the development of plagiocephaly. MATERIALS AND METHODS: A retrospective review of our database was performed to identify those infants who were of multiple-birth origin. The parents of these infants were contacted by phone to complete a survey regarding the prenatal and postnatal history of their child. Similar information was obtained for the state of Arizona from the Office of Vital Statistics. A chi2 analysis was used to compare the incidence of multiple births in Arizona with the incidence of multiple births in our treatment population. RESULTS: Between 1993 and 1996, 69 (8.6%) of the 801 infants treated for deformational plagiocephaly at our Phoenix center were of multiple-birth origin. Four infants who had been treated postoperatively after surgery for craniosynostosis, as well as 5 patients who had been referred from out of state, were excluded from further study. The chi2 analysis of the remaining 60 patients confirmed that a statistically significant number of plural-birth infants had presented with deformational plagiocephaly. Four risk factors were identified as having occurred at high frequency in this population: in utero constraint, supine sleeping position, torticollis, and prematurity. CONCLUSIONS: The current findings of this investigation confirm that a significant number of multiple-birth infants have presented to our clinic with deformational plagiocephaly. Compared with their singleton counterparts, plural infants seem to be at higher risk for the development of deformational plagiocephaly, because they are more likely to be exposed to multiple risk factors.deformational plagiocephaly, multiple birth, plurality.

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Dynamic Orthotic Cranioplasty (DOC) was developed to treat craniofacial deformities associated with positional plagiocephaly. This investigation describes the treatment of more than 750 patients with the DOC Band since 1988. All patients undergoing DOC treatment were fit with a custom fabricated orthosis made from a plaster impression taken from the infant's head. When the orthosis was applied, the corrective pressure was directed to hold growth at the calvarial prominences and redirect symmetrical growth. A detailed medical history was obtained and anthropometric measurements were taken at start, exit, 12, 18, and 24 months follow-up. This information was recorded in a database created in Microsoft Excel. Mean length of treatment was 4.3 months with an average entrance age of 6.9 months. Analysis of anthropometric data showed significant reduction in mean cranial vault, skull base, and facial asymmetries. Correction of the more difficult skull base was documented with computed tomography. Our anthropometric and clinical observations document complete or near complete correction of asymmetry for a wide variety of head shapes. Based on the results of this investigation, we are able to support the earlier claims of our pilot study, which concluded that DOC is effective in the treatment of positional plagiocephaly.

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In 1994 a set of triplets presented to the authors for treatment of their positional plagiocephaly with Dynamic Orthotic Cranioplasty (DOC). The three 8-month-old infants were diagnosed with severe, moderate, and mild plagiocephaly. Only the severe and moderate cases were treated with the DOC band. The mild case was not treated with the DOC band because it was thought that the condition could be addressed through alteration in the child's sleeping position. The child with severe deformation required 8.5 months of treatment with two DOC bands and had significant residual asymmetries at the end of the treatment course. The child with moderate deformity required 2.5 months of treatment with only one DOC band and had excellent correction of the initial asymmetries. The results of their treatment provide a unique forum for discussing the etiology of positional plagiocephaly, as well as those factors that can influence the efficacy of DOC treatment.

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PURPOSE: To compare the morphologic appearance and measurements of in situ keratomileusis performed with the UniversalKeratome (UK) with those done with the Automated Corneal Shaper (ACS). SETTING: Surgical suite within private practice. METHODS: Procedures were performed the same day on mate eye-bank eyes. In situ keratomileusis was done using existing nomograms for each instrument to resect a cap thickness of 160 microns and a myopic resection of 100 microns. Intraocular pressures were increased by inflating the globes with balanced salt solution and were measured with the suction fixation rings in place. The excised caps and stromal resections were measured twice independently after surgery, again after tissue fixation, and then evaluated with light and scanning electron microscopy. RESULTS: No complications were encountered. Compared with the ACS, the UK was easy to set up, use, clean, and take down. Its excised tissue dimensions were greater and more predictable, it resected a concave shaped lenticule (edges imperceptibly blending with the host stroma), and it created a smoother power resection surface and primary resection base. CONCLUSIONS: Smoother, predictable tissue resection, and simple assembly/disassembly and use give the UK an apparent advantage over the ACS. The UK corrects astigmatism and hyperopia by changing the shape of the poly(methyl methacrylate) optical insert.

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