Clinical Research
Cranial Technologies remains involved in the cutting edge of research for the prevention and treatment of plagiocephaly. Our researchers have been published extensively in peer-review medical journals, and present papers at national and international medical meetings. Cranial Technologies maintains the largest database on deformational plagiocephaly in the world and also funds research studies investigating the cause and prevention of plagiocephaly.
Cranial Technologies initially began conducting research in the mid-1990s in response to the lack of significant research on the topic available at that time. Cranial Technologies’ research efforts increased when the DOC Band became the first cranial orthosis to undergo the FDA approval process. Since there weren’t any other FDA-cleared products on the market at that time, extensive research was needed to prove the necessity, safety and treatment outcomes of the DOC Band®. Many competitive cranial orthotic products on the market today are able to exist thanks to Cranial Technologies’ research efforts.
A recent study looks at the effectiveness of the DOC Band for treatment of moderate and severe brachycephaly; see full article here.
A recent letter published in the AAP News, the official news magazine of the American Academy of Pediatrics, shares feedback on a recent European study. AAP News 2014;35;5
Pediatrics. 2013 Aug;132(2):298-304. doi: 10.1542/peds.2012-3438. Epub 2013 Jul 8. Mawji A, Vollman AR, Hatfield J, McNeil DA, Sauve R.
Abstract
Objective
The objective of this study was to estimate the incidence of positional plagiocephaly in infants 7 to 12 weeks of age who attend the 2-month well-child clinic in Calgary, Alberta, Canada.
Methods
A prospective cohort design was used to recruit 440 healthy full-term infants (born at ≥37 weeks of gestation) who presented at 2-month well-child clinics for public health nursing services (eg, immunization) in the city of Calgary, Alberta. The study was completed in 4 community health centers (CHCs) from July to September 2010. The CHCs were selected based on their location, each CHC representing 1 quadrant of the city. Argenta’s (2004) plagiocephaly assessment tool was used to identify the presence or absence of plagiocephaly.
Results
Of the 440 infants assessed, 205 were observed to have some form of plagiocephaly. The incidence of plagiocephaly in infants at 7 to 12 weeks of age was estimated to be 46.6%. Of all infants with plagiocephaly, 63.2% were affected on the right side and 78.3% had a mild form.
Conclusions
To our knowledge, this is the first population-based study to investigate the incidence of positional plagiocephaly using 4 community-based data collection sites. Future studies are required to corroborate the findings of our study. Research is required to assess the incidence of plagiocephaly using Argenta’s plagiocephaly assessment tool across more CHCs and to assess prevalence at different infant age groups. The utility of using Argenta’s plagiocephaly assessment tool by public health nurses and/or family physicians needs to be established.
Copyright © 2013 American Academy of Pediatrics.
Int J Oral Maxillofac Surg. 2014 Oct;43(10):1171-5. doi: 10.1016/j.ijom.2014.05.011. Epub 2014 Jul 15. Kluba S Lypke J, Kraut W, Krimmel M, Haas-Lude K, Reinert S
Abstract
Positional plagiocephaly in infants is frequent. As well as positioning, physiotherapy, and osteopathy, helmet therapy is an effective treatment option. The outcome also depends on the timely initiation of treatment. We investigated the preclinical pathways to treatment.
Parents of 218 affected children were interviewed. Data were collected regarding detection and the treatments used prior to the first craniofacial consultation at the study clinic in Germany. Descriptive and statistical analyses were performed. For 78.4% of the children, the cranial deformities were first detected at ≤4 months of age. One hundred and twenty-two children received helmet therapy. Parents consulted the pediatrician with a mean latency of 0.4 months; 3.3 months passed until the first craniofacial consultation.
Approximately 90% were treated with repositioning and 75.2% received additional physiotherapy or osteopathy prior to presentation. Children treated with physiotherapy/osteopathy presented significantly later (P=0.023). The time-lapse to craniofacial consultation was not significantly different between children with and without later helmet therapy. We identified a relevant delay between the detection of positional cranial deformity and consultation with a craniofacial specialist.
For affected children, this may potentially compromise the outcome of helmet therapy. Early referral to a specialist and if necessary the simultaneous application of different treatments should be preferred.
Copyright © 2014 International Association of Oral and Maxillofacial Surgeons.
J Craniomaxillofac Surg. 2014 Jul;42(5):683-8.
Kluba S, Kraut W, Calgeer B, Reinert S, Krimmel M.,
Abstract
Introduction
Positional plagiocephaly has attained widespread attention. There is a lot of data on helmet therapy available, but the natural course of the deformity has not been investigated in depth. The decision for or against helmet therapy can be controversial. This study examined the outcome of both options.
Methods
128 infants were enrolled in this prospective, non-randomized, longitudinal study. 62 were treated with and 66 without a helmet. The initial cranial vault asymmetry index (modified CVAI) was determined at 6.3 and 6.2 months of age (SD 1.44/2.14). Follow-up took place at the end of helmet therapy (age: 10.2 months, SD 1.77) or after 1 year (age: 18.5 months, SD 2.28) respectively. The outcome and the correlation of the changes to the initial asymmetry were compared.
Results
All infants showed a significant reduction of their plagiocephaly. Although children with helmet had more severe asymmetry initially, they showed significantly better improvement (68% vs. 31%). Only a weak correlation was found between the initial asymmetry and the amount of improvement in both groups.
Conclusion
Despite concerns against helmet therapy (comfort, finances), it should be the treatment of choice for moderate to severe cases. Only mild cases (modified CVAI ≤ 6.5%) can be adequately treated by conservative, i.e. non-helmet, management.
Copyright © 2013 European Association for Cranio-Maxillo-Facial Surgery.
Plast Reconstr Surg. 2013 Jan;131(1):55e-61e SeruyaM, OhAK, Taylor JH, Sauerhammer TM, Rogers GF Department of Plastic and Reconstructive Surgery, Children’s National Medical Center, Washington, DC 20010, USA.
Abstract
Background
The purpose of this study was to evaluate the relationship between age at initiation of helmet therapy for deformational plagiocephaly and the rate of correction.
Methods
Infants treated for deformational plagiocephaly with a helmet orthosis between 2009 and 2010 were included. Patients were stratified prospectively by the age at which treatment was initiated: group 1, younger than 20 weeks (n = 26); group 2, 20 to 23.9 weeks (n = 59); group 3, 24 to 27.9 weeks (n = 82); group 4, 28 to 31.9 weeks (n = 62); group 5, 32 to 35.9 weeks (n = 45); group 6, 36 to 40 weeks (n = 29), and group 7, older than 40 weeks (n = 43). Pretreatment and posttreatment calvarial asymmetry was measured using direct anthropometry and reported as a transcranial difference.
Results
Three hundred forty-six infants were included; initial transcranial difference was equivalent on all paired-group comparisons. Duration of helmet therapy positively correlated with age at initiation (r = 0.89, p < 0.05). The rate of change in transcranial difference correlated negatively with age at treatment onset (r = -0.88, p < 0.05): group 1, 0.93 mm/week; group 2, 0.64 mm/week; group 3, 0.59 mm/week; group 4, 0.56 mm/week; group 5, 0.41 mm/week; group 6, 0.42 mm/week; and group 7, 0.42 mm/week). At the conclusion of therapy, all groups had improved calvarial symmetry, albeit less completely in groups 6 and 7.
Conclusions
The correction rate of plagiocephaly with helmet therapy decreases with increasing infant age; after 32 weeks, there is a slow and relatively constant rate of change. Improvement can still be achieved in infants older than 12 months.
Copyright © 2013 American Society of Plastic Surgeons.
Cleft Palate Craniofacial Journal. 2008. May;45(3):240-5. doi: 10.1597/06-210.1 Epub 2007 Jul 17. Lee R, Teichgraeber JF, Baumgartner JE, Waller AL, English JD, et al.
Abstract
To evaluate the long-term effectiveness of helmet therapy in the correction of deformational plagiocephaly and to assess the early occlusal abnormalities seen in these patients.
A prospective study with blinded measurements.
Of the 440 infants assessed, 205 were observed to have some form of plagiocephaly. The incidence of plagiocephaly in infants at 7 to 12 weeks of age was estimated to be 46.6%. Of all infants with plagiocephaly, 63.2% were affected on the right side and 78.3% had a mild form.
The average length of molding helmet treatment was 6.2 months. At the time of this follow-up evaluation, the mean interval since completing the molding helmet therapy was 5.6 years.
Anthropometric measurements of cranial asymmetry included cranial vault asymmetry (CVA), orbitotragial depth asymmetry (OTDA), and cranial base asymmetry (CBA). A dental examination was also performed.
At the completion of therapy, the most improvement was seen in the measurement of CBA, followed by CVA and OTDA. However, in evaluating the long-term stability of molding treatment, OTDA tended to continue improving after the initial treatment, while CBA and CVA appeared to regress, although none of the changes reached statistically significant levels. In dental measurements, all the dental midline and chin deviations were toward the unaffected side with respect to occipital deformation.
This study demonstrated that helmet remodeling with the dynamic orthotic cranioplasty band is effective in the correction of cranial asymmetry, with some nonstatistically significant changes in long-term cranial vault symmetry. Dental observations indicated the possibility of occlusal abnormalities that may affect dental, especially orthodontic, diagnosis and treatment planning.
Copyright © 2008 Cleft Palate and Craniofacial Journal
Cleft Palate Craniofac J. 2002 Nov;39(6):582-6. doi: 10.1597/1545-1569_2002_039_0582_dppdat_2.0.co_2. PMID: 12401104. Teichgraeber JF, Ault JK, Baumgartner J, Waller A, Messersmith M, Gateño J, Bravenec B, Xia J.
Abstract
This study was designed to evaluate the effectiveness of helmet therapy (DOC band) in the correction of patients with moderate to severe posterior deformational plagiocephaly.
In this prospective study, the infants were evaluated using 18 anthropometric measurements.
The charts of 248 patients seen between August 1, 1995, and July 31, 1999, were reviewed, and 125 met the criteria for inclusion in the study. All the patients had posterior deformational plagiocephaly with no other craniofacial deformities or medical conditions. Treatment was instituted prior to 1 year of age, and all patients were compliant with DOC band usage and had complete anthropometric measurements.
The study recorded a 41.56% (p < .001) reduction in cranial vault asymmetry and a 40.23% (p <.001) reduction in cranial base asymmetry. Orbitotragial asymmetry was improved 18.72% (p = .0738). The age at which treatment was begun was not a significant factor in predicting treatment outcomes.
Copyright © 2002 Cleft Palate and Craniofacial Journal
Semin Pediatr Neurol. 2004 Dec;11(4):268-77. doi: 10.1016/j.spen.2004.10.004. PMID: 15828711. Littlefield TR.
Abstract
Since the first cranial remodeling devices were introduced in 1979, both their design and availability have continued to evolve. Today, these devices are used to treat deformational plagiocephaly (plagiocephaly, brachycephaly, and dolichocephaly) and are used as adjuncts to surgery for craniosynostosis. In deformational plagiocephaly, the goal is to improve cranial symmetry and return the cranium to a more normal proportion. Postoperatively, these devices are used to provide stabilization and to enhance surgical outcomes. Numerous clinical studies have demonstrated the safety and efficacy of these devices by documenting statistically significant reductions in the cranial vault, skull base, and facial asymmetries as well as improvements in the cephalic index. These studies indicate that cranial remodeling devices play an important role in the treatment of cranial deformations.
Copyright © 2004 Seminars in Pediatric Neurology
Beals S, Joganic E, Littlefield TR. New Guidelines for the Diagnosis and Treatment of Deformational Plagiocephaly. Craniofacial Surgery X: Proceedings of the 10th International Congress of the International Society of Craniofacial Surgery. Published online 2003:49-51.
Cepeda A, Nguyen HT, Obinero C, et al. Characterization of Regional Morphological Changes in Metopic Craniosynostosis Following Endoscopic Strip Craniectomy With Postoperative Helmeting: Predictors for Success. FACE. 2023;4(4):466-472. doi:10.1177/27325016231191638
Dunning HN, Littlefield TR. Section 207: Is Your Class III Designation Really Final? For certain low-risk medical devices classified into Class III, the de novo process can be a welcome alternative to costly PMAs. Medical Device and Diagnostic Industry. 1999;21:117-123.
Golden KA, Beals SP, Littlefield TR, Pomatto JK. Sternocleidomastoid imbalance versus congenital muscular torticollis: their relationship to positional plagiocephaly. The Cleft palate-craniofacial journal. 1999;36(3):256-261.
Hauc SC, Junn AH, Long AS, et al. Orthotic Helmet Therapy for Deformational Plagiocephaly: Stratifying Outcomes by Insurance. The Cleft Palate Craniofacial Journal. Published online January 18, 2023:105566562311525. doi:10.1177/10556656231152517
Hauc SC, Long AS, Littlefield TR, et al. Role of State Insurance Policy in Orthotic Helmet Access for Deformational Plagiocephaly. Plastic & Reconstructive Surgery. 2023;152(1):125-135. doi:10.1097/PRS.0000000000010231
Hauc SC, Long AS, Rivera JC, et al. Predictive Factors of Outcomes in Helmet Therapy for Deformational Plagiocephaly and Brachycephaly. Journal of Craniofacial Surgery. 2023;34(1):231-234. doi:10.1097/SCS.0000000000009048
Joganic JL, Lynch JM, Littlefield TR, Verrelli BC. Risk factors associated with deformational plagiocephaly. Pediatrics. 2009;124(6):e1126-e1133.
Kelly KM, Joganic EF, Beals SP, Riggs JA, McGuire MK, Littlefield TR. Helmet Treatment of Infants With Deformational Brachycephaly. Global Pediatric Health. 2018;5:2333794X18805618. doi:10.1177/2333794x18805618
Kelly KM, Littlefield TR, Pomatto JK, Manwaring KH, Beals SP. Cranial growth unrestricted during treatment of deformational plagiocephaly. Pediatric neurosurgery. 1999;30(4):193-199.
Kelly KM, Littlefield TR, Pomatto JK, Ripley CE, Beals SP, Joganic EF. Importance of early recognition and treatment of deformational plagiocephaly with orthotic cranioplasty. The Cleft palate-craniofacial journal. 1999;36(2):127-130.
Littlefield TR, Pomatto JK, Beals SP, Manwaring KH, Joganic EF, Ripley CE. Efficacy and stability of dynamic orthotic cranioplasty: an eight year investigation. In: ; 1997:109-111.
Littlefield TR. Food and Drug Administration regulation of orthotic cranioplasty. The Cleft palate-craniofacial journal. 2001;38(4):337-340.
Littlefield TR. Cranial remodeling devices: treatment of deformational plagiocephaly and postsurgical applications. In: Vol 11. Elsevier; 2004:268-277.
Littlefield TR. FDA regulation of cranial remodeling devices. JPO: Journal of Prosthetics and Orthotics. 2004;16(4):S35-S38.
Littlefield TR, Dunning N. U.S. FDA regulation of orthotic treatment of deformational plagiocephaly. Journal of Craniofacial Surgery. 1999; volume 8(3).
Littlefield TR, Beals SP, Manwaring KH, et al. Treatment of craniofacial asymmetry with dynamic orthotic cranioplasty. Journal of Craniofacial Surgery. 1998;9(1):11-17.
Littlefield TR, Cherney JC, Luisi JN, Beals SP, Kelly KM, Pomatto JK. Comparison of plaster casting with three-dimensional cranial imaging. The Cleft palate-craniofacial journal. 2005;42(2):157-164.
Littlefield TR, HESS RM, KELLY KM, POMATTO JK. Cranial remodeling: From cultural practice to contemporary treatment of cranial deformities. Biométrie humaine et anthropologie. 2005;23(1-2):43-52.
Littlefield TR, Kelly KM. Deformational plagiocephaly: recommendations for future research. JPO: Journal of Prosthetics and Orthotics. 2004;16(4):S59-S62.
Littlefield TR, Kelly KM, Cherney JC, Beals SP, Pomatto JK. Development of a new three-dimensional cranial imaging system. Journal of Craniofacial Surgery. 2004;15(1):175-181.
Littlefield TR, Kelly KM, Pomatto JK, Beals SP. Multiple-birth infants at higher risk for development of deformational plagiocephaly. Pediatrics. 1999;103(3):565-569.
Littlefield TR, Kelly KM, Pomatto JK, Beals SP. Multiple-birth infants at higher risk for development of deformational plagiocephaly: II. Is one twin at greater risk? Pediatrics. 2002;109(1):19-25.
Littlefield TR, Kelly KM, Reiff JL, Pomatto JK. Car seats, infant carriers, and swings: their role in deformational plagiocephaly. JPO: Journal of Prosthetics and Orthotics. 2003;15(3):102-106.
Littlefield TR, Pomatto JK, Kelly KM. Dynamic orthotic cranioplasty: treatment of the older infant. Report of four cases. Neurosurgical focus. 2000;9(3):1-4.
Littlefield TR, Reiff JL, Rekate HL. Diagnosis and management of deformational plagiocephaly. BNI Q. 2001;17(4):18-25.
Littlefield TR, Saba NM, Kelly KM. On the current incidence of deformational plagiocephaly: an estimation based on prospective registration at a single center. In: Vol 11. Elsevier; 2004:301-304.
Littlefield TR. Comparison of Plaster Casting Versus 3D Imaging for the Treatment of Deformational Plagiocephaly. Craniofacial Surgery X: Proceedings of the Tenth International Congress of the International Society of Craniofacial Surgery. Published online 2003:427-430.
Littlefield TR. Craniofacial Growth Unrestricted During DOC Treatment of Plagiocpehaly. Craniofacial Surgery VIII: Proceedings of the Eight International Congress of the International Society of Craniofacial Surgery. Published online 1999.
Liu Y, Freitas RDS, Pomatto-Hertz J, Littlefield T, Persing JA, Shin JH. Orthotic treatment improves cranial base abnormality in patients with craniofacial microsomia and deformational plagiocephaly.
Liu Y, Freitas R da S, Pomatto-Hertz J, Littlefield T, Persing JA, Shin JH. Orthotic treatment improves cranial base abnormality in patients with craniofacial microsomia and deformational plagiocephaly. Rev Soc Bras Cir Craniomaxilofac. 2008;11(2):62-65.
Nguyen HT, Washington GN, Cepeda A, et al. Characterization of Regional Morphological Changes in Sagittal Craniosynostosis Following Endoscopic Strip Craniectomy With Post-operative Helmeting: Predictors for Success. Journal of Craniofacial Surgery. 2023;34(6):1677-1681. doi:10.1097/SCS.0000000000009433
Nguyen HT, Washington GN, Cepeda A, et al. Evaluation of Helmeting Therapy Duration After Endoscopic Strip Craniectomy for Metopic and Sagittal Craniosynostosis. Journal of Craniofacial Surgery. 2024;35(2):415-418. doi:10.1097/SCS.0000000000009887
Pomatto JK, Beals SP, Joganic EF, Littlefield TR. Preliminary results and new treatment protocol for cranial banding following endoscopic-assisted craniectomy for sagittal synostosis. International Society of Craniofacial Surgery IX, Visby, Gotland, Sweden. Published online 2001.
Pomatto JK, Calcaterra J, Kelly KM, Beals SP, Manwaring KH, Littlefield TR. A study of family head shape: environment alters cranial shape. Clinical pediatrics. 2006;45(1):55-63.
Pomatto JK, Littlefield TR, Manwaring K, Beals SP. Etiology of positional plagiocephaly in triplets and treatment using a dynamic orthotic cranioplasty device: report of three cases. Neurosurgical focus. 1997;2(2):E4.
Pomatto JL, et al. Postoperative Use of Cranial Remodeling Devices. Craniofacial Surgery XI: Proceedings of the Eleventh International Congress of the International Society of Craniofacial Surgery. Published online 2005:251-253.