A cranial remolding helmet, or orthosis, is a device used to treat head shape deformities such as plagiocephaly, brachycephaly and scaphocephaly. The helmet treatment is effective in infants from 3-18 months of age, but optimal when started younger due to the decrease in growth rate as the child ages. The first cranial remolding helmet was developed by Dr. Clarren in 1979. At Union Orthotics and Prosthetics Co., we provide the STAR family of cranial remolding helmets by Orthomerica Inc. The STARscanner and cranial remolding orthoses are FDA regulated.

The head shape improves by providing contact at the bossed areas to stop growth while providing pockets of space at the flattened areas for the skull to naturally grow into. The amount of improvement is directly proportional to the amount of growth during their time in the helmet. These are worn 23 hours per day to capture all of the growth. It is most beneficial to begin as young as possible. As infants age, their skull growth slows down and less improvement is possible. Most of our patients are completed by 12 months of age.

The most common cause of head shape deformation is supine, laying on the back, sleep positioning. An infant's head triples in size in the first 12 months of life. During this time, their head is susceptible to external pressure that may influence the shape such as inutero constraint, supine positioning for sleep or in devices such as car seats, recliners and swings. Increased risk factors include multiple births, prematurity and torticollis.

Torticollis is a condition in which a tight neck muscle on one side causes the head to tilt and turn in one direction more than the other. This causes unequal pressure on the head when laying on a surface which can lead to Plagiocephaly. Physical therapy is recommended to stretch, strengthen and improve range of motion at the neck.

Aggressive repositioning is when the caregivers position the baby so pressure is away from the areas of flatness. Tummy time is an example of aggressive repositioning. Repositioning is the best method to prevent head shape deformities and may alone improve existing deformity. If there is still flatness after two months of repositioning, a helmet may be necessary. Repositioning and tummy time is important for ALL infants. Since infants spend the majority of time on their backs, spending waking hours on their tummy is critical in strengthening for normal physical development.

A cranial remolding helmet is needed when the flatness is still moderate or severe after two months of repositioning have been attempted. It can take many weeks for all the necessary steps to be taken so start talking to your pediatrician as soon as possible.

A prescription is required for an evaluation or a cranial remolding orthosis. Prescriptions can come from a pediatrician or specialists from the craniofacial or neurosurgery departments at the local hospitals. The a specialists would rule out other potential more serious issues which cause head shape deformities such as craniosynostosis (premature fusing of a cranial suture). If a cranial remolding orthosis is prescribed, you will set up an initial evaluation appointment with a certified orthotist who will perform a STARscan to confirm the severity as well as submit the claim to your insurance to determine coverage. At Union Orthotics & Prosthetics Co. we offer free scan evaluations.

The FDA requires cranial remolding orthoses to be fit within 14 days from the scan date. Prolonging this timeframe could lead to an ill-fitting orthosis due to the infant’s growth. If insurance has not yet approved the orthosis an updated scan may be needed.

98% of our patient’s get their cranial remolding orthosis approved through their health insurance plan. Most of these are approved within a few days of the scan appointment. Our authorization team will process the claim and update you as needed. Many health insurance companies have clinical criteria which must be met for coverage. At times a plan exclusion may include this device. You may call and ask their coverage policy for a cranial remolding orthosis which is under the device code S1040.

STARscanner
Scanning eliminates the casting process required for custom-molded cranial remolding helmet. No eyewear or protection is needed. The scan data is sent to Orthomerica electronically and downloaded to a 5-axis carver for precise fabrication of a cranial remolding orthosis. This non-invasive diagnostic screening tool also includes customized software that allows the orthotist to gather, analyze and quantify clinical outcomes. The software collects surface data on slices through pediatric head shapes and provides comparative maps of head shape, as well as cross-sectional slice comparisons. For the first time, the orthotist has quantitative information that can be used to support positive clinical outcomes for cranial remolding orthoses to physicians, therapists, caregivers, and insurance companies.

Union Orthotics & Prosthetics Co. utilizes two scanning technologies, the STARscanner and the SmartSoc. The STARscanner is offered at our main office location. The portable Smartsoc is offered at these locations: Canonsburg, Cranberry, Erie, Indiana, Monroeville, South Park and Titusville. See the links below to learn more.

In order to ensure the fit and function of the helmet, we schedule regular follow-up visits. The initial follow-up is about one week after the fitting. Subsequent follow-ups are scheduled every 2-4 weeks depending on the age and severity of the child.

The length of use depends on severity, age and developmental milestones. Most infants are discharged between 10-12 months of age. Developmental milestones we recommend should be met include crawling, rolling around while sleeping and no preference turning the head to one side. Once these are met, the head shape is no longer at risk for worsening with future growth, but if the orthosis is not worn, no further improvements should be expected either. Once discharged upon these criteria, the growth should occur evenly everywhere maintaining the current shape.

The vast majority of our patients only require one helmet. A second one may be needed if the child begins at an early age or if physical changes exceed the amount of adjustability.