Cranial Technologies

Clinical Research

Research & Literature

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


The incidence of positional plagiocephaly: a cohort study

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.


Preclinical pathways to treatment in infants with positional cranial deformity

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.


Treatment of positional plagiocephaly–helmet or no helmet?

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.


Helmet treatment of deformational plagiocephaly: the relationship between age at initiation and rate of correction.

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.


Long-term treatment effectiveness of molding helmet therapy in the correction of posterior deformational plagiocephaly

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

Objective

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.

Design

A prospective study with blinded measurements.

Patients

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.

Interventions

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.

Main Outcome measures

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.

Results

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.

Conclusion

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


Deformational posterior plagiocephaly: diagnosis and treatment

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

Objective

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.

Design

In this prospective study, the infants were evaluated using 18 anthropometric measurements.

Patients

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.

Results

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


Cranial remodeling devices: treatment of deformational plagiocephaly and postsurgical applications

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


Cranial Technologies Publications

  1. Beals S, Joganic E, Li3lefield TR. New Guidelines for the Diagnosis and Treatment of DeformaBonal Plagiocephaly. Craniofacial Surgery X: Proceedings of the 10th InternaBonal Congress of the InternaBonal Society of Craniofacial Surgery. Published online 2003:49-51.
  2. Cepeda A, Nguyen HT, Obinero C, et al. CharacterizaBon of Regional Morphological Changes in Metopic Craniosynostosis Following Endoscopic Strip Craniectomy With PostoperaBve HelmeBng: Predictors for Success. FACE. 2023;4(4):466-472. doi:10.1177/27325016231191638
  3. Dunning HN, Li3lefield TR. SecBon 207: Is Your Class III DesignaBon Really Final? For certain low-risk medical devices classified into Class III, the de novo process can be a welcome alternaBve to costly PMAs. Medical Device and DiagnosBc Industry. 1999;21:117-123.
  4. Golden KA, Beals SP, Li3lefield TR, Poma3o JK. Sternocleidomastoid imbalance versus congenital muscular torBcollis: their relaBonship to posiBonal plagiocephaly. The Clee palate-craniofacial journal. 1999;36(3):256-261.
  5. Hauc SC, Junn AH, Long AS, et al. OrthoBc Helmet Therapy for DeformaBonal Plagiocephaly: StraBfying Outcomes by Insurance. The Clee Palate Craniofacial Journal. Published online January 18, 2023:105566562311525. doi:10.1177/10556656231152517
  6. Hauc SC, Long AS, Li3lefield TR, et al. Role of State Insurance Policy in OrthoBc Helmet Access for DeformaBonal Plagiocephaly. PlasBc & ReconstrucBve Surgery. 2023;152(1):125-135. doi:10.1097/PRS.0000000000010231
  7. Hauc SC, Long AS, Rivera JC, et al. PredicBve Factors of Outcomes in Helmet Therapy for DeformaBonal Plagiocephaly and Brachycephaly. Journal of Craniofacial Surgery. 2023;34(1):231-234. doi:10.1097/SCS.0000000000009048
  8. Joganic JL, Lynch JM, Li3lefield TR, Verrelli BC. Risk factors associated with deformaBonal plagiocephaly. Pediatrics. 2009;124(6):e1126-e1133.
  9. Kelly KM, Joganic EF, Beals SP, Riggs JA, McGuire MK, Li3lefield TR. Helmet Treatment of Infants With DeformaBonal Brachycephaly. Global Pediatric Health. 2018;5:2333794X18805618. doi:10.1177/2333794x18805618
  10. Kelly KM, Li3lefield TR, Poma3o JK, Manwaring KH, Beals SP. Cranial growth unrestricted during treatment of deformaBonal plagiocephaly. Pediatric neurosurgery. 1999;30(4):193-199.
  11. Kelly KM, Li3lefield TR, Poma3o JK, Ripley CE, Beals SP, Joganic EF. Importance of early recogniBon and treatment of deformaBonal plagiocephaly with orthoBc cranioplasty. The Clee palate-craniofacial journal. 1999;36(2):127-130.
  12. Li3lefield TR, Poma3o JK, Beals SP, Manwaring KH, Joganic EF, Ripley CE. Efficacy and stability of dynamic orthoBc cranioplasty: an eight year invesBgaBon. In: ; 1997:109-111.
  13. Li3lefield TR. Food and Drug AdministraBon regulaBon of orthoBc cranioplasty. The Clee palate-craniofacial journal. 2001;38(4):337-340.
  14. Li3lefield TR. Cranial remodeling devices: treatment of deformaBonal plagiocephaly and postsurgical applicaBons. In: Vol 11. Elsevier; 2004:268-277.
  15. Li3lefield TR. FDA regulaBon of cranial remodeling devices. JPO: Journal of ProstheBcs and OrthoBcs. 2004;16(4):S35-S38.
  16. Li3lefield TR, Dunning N. U.S. FDA regulaBon of orthoBc treatment of deformaBonal plagiocephaly. Journal of Craniofacial Surgery. 1999; volume 8(3).
  17. Li3lefield TR, Beals SP, Manwaring KH, et al. Treatment of craniofacial asymmetry with dynamic orthoBc cranioplasty. Journal of Craniofacial Surgery. 1998;9(1):11-17.
  18. Li3lefield TR, Cherney JC, Luisi JN, Beals SP, Kelly KM, Poma3o JK. Comparison of plaster casBng with three-dimensional cranial imaging. The Clee palatecraniofacial journal. 2005;42(2):157-164.
  19. Li3lefield TR, HESS RM, KELLY KM, POMATTO JK. Cranial remodeling: From cultural pracBce to contemporary treatment of cranial deformiBes. Biométrie humaine et anthropologie. 2005;23(1-2):43-52.
  20. Li3lefield TR, Kelly KM. DeformaBonal plagiocephaly: recommendaBons for future research. JPO: Journal of ProstheBcs and OrthoBcs. 2004;16(4):S59-S62.
  21. Li3lefield TR, Kelly KM, Cherney JC, Beals SP, Poma3o JK. Development of a new three-dimensional cranial imaging system. Journal of Craniofacial Surgery. 2004;15(1):175-181.
  22. Li3lefield TR, Kelly KM, Poma3o JK, Beals SP. MulBple-birth infants at higher risk for development of deformaBonal plagiocephaly. Pediatrics. 1999;103(3):565- 569.
  23. Li3lefield TR, Kelly KM, Poma3o JK, Beals SP. MulBple-birth infants at higher risk for development of deformaBonal plagiocephaly: II. Is one twin at greater risk? Pediatrics. 2002;109(1):19-25.
  24. Li3lefield TR, Kelly KM, Reiff JL, Poma3o JK. Car seats, infant carriers, and swings: their role in deformaBonal plagiocephaly. JPO: Journal of ProstheBcs and OrthoBcs. 2003;15(3):102-106.
  25. Li3lefield TR, Poma3o JK, Kelly KM. Dynamic orthoBc cranioplasty: treatment of the older infant. Report of four cases. Neurosurgical focus. 2000;9(3):1-4.
  26. Li3lefield TR, Reiff JL, Rekate HL. Diagnosis and management of deformaBonal plagiocephaly. BNI Q. 2001;17(4):18-25.
  27. Li3lefield TR, Saba NM, Kelly KM. On the current incidence of deformaBonal plagiocephaly: an esBmaBon based on prospecBve registraBon at a single center. In: Vol 11. Elsevier; 2004:301-304.
  28. Li3lefield TR. Comparison of Plaster CasBng Versus 3D Imaging for the Treatment of DeformaBonal Plagiocephaly. Craniofacial Surgery X: Proceedings of the Tenth InternaBonal Congress of the InternaBonal Society of Craniofacial Surgery. Published online 2003:427-430.
  29. Li3lefield TR. Craniofacial Growth Unrestricted During DOC Treatment of Plagiocpehaly. Craniofacial Surgery VIII: Proceedings of the Eight InternaBonal Congress of the InternaBonal Society of Craniofacial Surgery. Published online 1999.
  30. Liu Y, Freitas RDS, Poma3o-Hertz J, Li3lefield T, Persing JA, Shin JH. OrthoBc treatment improves cranial base abnormality in paBents with craniofacial microsomia and deformaBonal plagiocephaly.
  31. Liu Y, Freitas R da S, Poma3o-Hertz J, Li3lefield T, Persing JA, Shin JH. OrthoBc treatment improves cranial base abnormality in paBents with craniofacial microsomia and deformaBonal plagiocephaly. Rev Soc Bras Cir Craniomaxilofac. 2008;11(2):62-65.
  32. Nguyen HT, Washington GN, Cepeda A, et al. CharacterizaBon of Regional Morphological Changes in Sagi3al Craniosynostosis Following Endoscopic Strip Craniectomy With Post-operaBve HelmeBng: Predictors for Success. Journal of Craniofacial Surgery. 2023;34(6):1677-1681. doi:10.1097/SCS.0000000000009433
  33. Nguyen HT, Washington GN, Cepeda A, et al. EvaluaBon of HelmeBng Therapy DuraBon Aeer Endoscopic Strip Craniectomy for Metopic and Sagi3al Craniosynostosis. Journal of Craniofacial Surgery. 2024;35(2):415-418. doi:10.1097/SCS.0000000000009887
  34. Poma3o JK, Beals SP, Joganic EF, Li3lefield TR. Preliminary results and new treatment protocol for cranial banding following endoscopic-assisted craniectomy for sagi3al synostosis. InternaBonal Society of Craniofacial Surgery IX, Visby, Gotland, Sweden. Published online 2001.
  35. Poma3o JK, Calcaterra J, Kelly KM, Beals SP, Manwaring KH, Li3lefield TR. A study of family head shape: environment alters cranial shape. Clinical pediatrics. 2006;45(1):55-63.
  36. Poma3o JK, Li3lefield TR, Manwaring K, Beals SP. EBology of posiBonal plagiocephaly in triplets and treatment using a dynamic orthoBc cranioplasty device: report of three cases. Neurosurgical focus. 1997;2(2):E4.
  37. Poma3o JL, et al. PostoperaBve Use of Cranial Remodeling Devices. Craniofacial Surgery XI: Proceedings of the Eleventh InternaBonal Congress of the InternaBonal Society of Craniofacial Surgery. Published online 2005:251-253.