Frequently Asked Questions

Is one style of cranial remolding orthosis better than another?

Currently there are no studies that compare one product to another. The FDA actively regulates the manufacturing process of all cranial remolding orthoses styles, and each design offered by Orthomerica has received FDA clearance. The specific cranial design is selected based on the infant’s head shape and the treatment preferences of the orthotist and the referring physician.

Why would my physician or orthotist choose a cranial remolding orthosis manufactured by Orthomerica?

There are many reasons why Orthomerica products are preferred.

1. Orthomerica has an experienced cranial support team who work to provide the best cranial remolding orthoses available on the market.

2. Orthomerica is an FDA Registered Medical Device Manufacturer, fully compliant with the U.S. FDA Quality System Regulation (QSR) and its Current Good Manufacturing Practices (CGMP). Currently, Orthomerica has four 510K’s under which the FDA permits Orthomerica to produce multiple designs of Cranial Remolding Orthoses. This represents twice the number of 510K’s held by any other manufacturer in the world! Additionally, Orthomerica is certified to ISO-9001, the International Standard for Quality Systems, and markets its products around the globe.

3. Orthomerica has two Clinical Education Managers on staff who are published and nationally recognized speakers in the orthotic management of infants with deformational Plagiocephaly and other head shape problems. They have lectured and provided courses worldwide to pediatric neurosurgeons and plastic surgeons, as well as, to pediatricians, therapists, nurses, and other health care providers. They have written brochures about the prevention of deformational Plagiocephaly, and have collaborated with other health care professionals to study the effectiveness of repositioning, physical and occupational therapy and its impact on orthotic intervention.

4. Orthomerica’s on-site certified orthotist provides ongoing consultation and information to orthotists, and specially trained customer service specialists track every cranial order to ensure the proper fabrication and specifications of the orthosis. Each step of the fabrication process has quality control checks and balances in place to ensure the quality of the orthosis.

5. Orthomerica has worked with physicians and orthotists throughout the United States to develop and offer a variety of cranial remolding orthosis designs that would best address the needs of babies with very complex head shapes.

6. Orthomerica has teamed up with leading hospitals and physicians, such as Children’s Hospital of Atlanta and Sterling Clarren, MD, of Seattle Children’s Hospital, to conduct research concerning cranial remolding orthoses and the treatment of plagiocephaly. Dr. Clarren was the originator of modern cranial remolding orthoses, and in 1979, was the first to publish an article on the topic. This past year, Orthomerica was selected to exclusively fabricate all Clarren Helmets worldwide.

7. Orthomerica is the first cranial remolding orthosis manufacturer to incorporate scanning technology with the treatment of infants with deformational Plagiocephaly. For over three years, centers across the United States have used Orthomerica’s STARscanner — a laser data acquisition system that replaces the casting process traditionally required for obtaining a mold of the infant’s head. Thousands of infants have benefited from this technology, which is safe, accurate, and fast — taking less than 2 seconds. The STARscanner is also an excellent tool for collecting data to measure the progress of patient treatment, for insurance documentation, and for clinical research studies.

What kind of health care professional will be treating my child?

Your pediatrician or craniofacial specialist will prescribe a cranial remolding orthosis for your infant. You will then be referred to a credentialed orthotist or prosthetist who will provide the cranial orthosis and the ongoing treatment program. These allied health care professionals are specifically trained and educated to provide and manage the provision of custom orthoses (braces) and prostheses (artificial limbs).

Credentialed orthotists and prosthetists have provided cranial remolding orthoses for more than 25 years. These health care practitioners maintain high standards of continuing education through national certifying bodies and many have specialized pediatric orthotic practices. As key medical team members, these practitioners bring value to the orthotic treatment program with a strong background in anatomy, biomechanics, material science and patient care. These practitioners also work closely with other members of the health care team to provide quality orthotic management to ensure that your infant has optimal results.

How do I get an Orthomerica cranial remolding orthosis for my infant?

First, you will need to get a prescription from a physician for a cranial remolding orthosis. Referrals as to where to go and who to see will depend upon your physician, insurance company and the caregiver. In some cases, your physician may refer you to a specific facility or practitioner for treatment because he/she has a working relationship with this allied health care professional. If you have insurance, your insurance company may require you to go to a network provider to minimize your out-of-pocket expenses.

Use this link for a directory of facilities accredited by the American Board for Certification (ABC). These facilities can be contacted to determine if they are an experienced provider of Orthomerica’s Cranial Remolding Orthoses. You may also contact Orthomerica’s Customer Service department at custserv@orthomerica.com. Please include your city and state in the email message, and a customer service representative at Orthomerica will respond with a list of orthotists in your area who currently provide Orthomerica’s cranial remolding orthoses. It is in your best interest to thoroughly interview the practitioner(s) and make sure that you feel comfortable in your communications with the facility and the practitioner. We highly recommend that you ask prospective orthotists specific questions. Click here for a list of sample questions.

What is the history of cranial remolding orthoses?

Orthotists and prosthetists have treated children with deformational Plagiocephaly since the 1970s. The first article written about the use of cranial remolding orthoses to treat deformational Plagiocephaly was written by Drs. Clarren, Smith, and Hanson in 1979 in a study done at the University of Washington. In 1998 the FDA ruled that cranial remolding orthoses fell into the category of Class II medical devices and required strict control standards. In order to continue providing these orthoses, centers had to apply for and receive FDA 510(k) clearance, which is an expensive and labor intensive process. Many orthotists and prosthetists stopped providing cranial remolding orthoses at that time because their design had not gone through the process of being cleared by the FDA. In July 2000, Orthomerica received 510(k) clearance to manufacture and market the STARband.

Orthomerica’s intent is to make cranial remolding treatment more accessible, so parents do not have to travel long distances at great expense for these services. Orthomerica makes this possible by providing cranial remolding orthoses that credentialed orthotists and prosthetists can use to treat infants in their local communities. The STARband, STARlight and Clarren designs offer new options in the management of deformational Plagiocephaly and brachycephaly, and have been welcomed by physicians, insurance companies, and parents as affordable and effective orthotic designs.

Do all credentialed orthotists and prosthetists have experience providing cranial remolding orthoses?

Not necessarily. Individual orthotists and prosthetists have varying levels of experience with different types of orthoses. The educational background of these health care practitioners enables them to evaluate and assess the patient’s needs, and apply orthotic management principles to each patient. Evaluation, orthotic design, material properties, casting, fitting, and follow-up are integrated into the experience of every practitioner, and they have a high level of competency in these areas. You may want to interview several local practitioners before choosing the one that is right for you and your child.

Consultation and information about cranial remolding orthosis treatment, using STARband, STARlight, and Clarren Helmet products, are available from the Clinical Education Managers at Orthomerica via telephone and printed information. In addition, Orthomerica sponsors and presents educational courses on the topic for practitioners throughout the United States.

What is the difference between a casting and scanning procedure?

Each cranial remolding orthosis is a custom product, meaning that each orthosis is specifically made to fit each infant. In order to create such an intimately fitting and effective orthosis, a 3-D model of the patient’s head is needed. Currently, there are two means of obtaining this 3-D model — 1) a cast impression of the infant’s head, or 2) a scan.

The casting process involves laying a series of plaster splints over the infant’s head and molding them as they dry. The cast is removed, producing a negative impression of the infant’s head. The entire process takes between 15 and 30 minutes. The negative impression is then filled with liquid plaster to produce a positive, 3-D model of the infant’s head.

The STARscanner is safe, accurate up to a half millimeter, eliminates the need for casting, and obtains data for a 3-D model of the infant’s head in less than two seconds. This type of scan also allows an infinite number of measurements to be taken of the head, and then compared throughout the treatment program. Currently, there are more than 12 orthotic and prosthetic facilities and hospitals across the country that have the STARscanner non-contact laser data acquisition system.

Once a cast or scan is sent to Orthomerica, how long will it take to get my child’s cranial remolding orthosis?

Once Orthomerica receives the cast impression or scan, the STARband will be shipped to the orthotist within 5 working days. Ideally, your child will be fit with an Orthomerica cranial remolding orthosis within 14 days of the casting/scanning date to assure proper fit and function. Since most insurance companies require approval prior to initiating orthotic treatment, it is important for the family and/or the orthotic facility to obtain this prior approval before casting/scanning the infant. Delays related to insurance coverage can be lengthy and frustrating because success in treatment is time sensitive and can have an impact on treatment results.

 

FAQ’s Continued