Postoperative Use of the Cranial Remodeling Orthosis

Timothy R. Littlefield; Rachel M. Hess; Jeanne K. Pomatto CO, BOC
Cranial Technologies, Inc
Tempe, Arizona

Use of cranial remodeling devices for the treatment of deformational plagiocephaly has become a standard of care in the United States. However, very little is reported in the medical literature about postoperative use of these devices.1 The first use of cranial remodeling bands following surgery for craniosynostosis was reported by Persing et al. in 1986 and Ham and Meyer in 1987.2,3 These authors report the development of 'skull molding caps' fabricated with Orthoplast (Dow Corning, Medical Products, Midland, MI) and used as an adjunct to surgery. While no quantitative data were provided, it was reported that use of these devices after surgery consistently improved "cranial vault form over what could be achieved by operation alone." In 1995, Joganic et al reported on 62 cases treated postoperatively (DOC Band, Cranial Technologies, Tempe AZ).4 Joganic concluded that "when effectively employed, it was possible in some cases to improve the result of surgery to a degree that a secondary operation was avoided" and that "occasionally, the objectives of a two-stage reconstruction could be accomplished in a single procedure."

Despite these reports, to date no one has reported the specific treatment protocols for use of these devices, or specifically demonstrated the results that can be achieved. The purpose of this investigation was to demonstrate the effectiveness of cranial remodeling following surgery for craniosynostosis. This investigation will examine use following all types of surgical procedures including the traditional strip-craniectomy, cranial vault remodeling, and the recently introduced endoscopic-assisted strip craniectomy.

Between January 2000 and June 2004, all patients treated postoperatively following surgery for craniosynostosis were included for study. Participants were included from 11 treatment centers across the United States. A detailed postoperative treatment protocol was established, and infants were fit with a custom cranial orthosis within seven to ten days after surgery, waiting only long enough for postoperative swelling to subside. The cranial remodeling bands were custom designed to take into consideration not only the age of the infant and suture affected, but more importantly the type and extent of the surgical procedure performed. Infants were seen as frequently as every five days to make adjustments to the band, monitor growth, and evaluate progress. A standardized series of medical photographs and anthropometric measurements were obtained preoperatively, postoperatively, at exit from treatment, and up to one year post-treatment.

The anthropometric measurements collected included maximum cranial length (glabellaopisthocranion), maximum cranial length (euryon-euryon), and circumference. The cephalic index ([cranial width ÷ cranial length] × 100) was calculated for each set of measurements.

Statistical analysis (paired t-test) of the anthropometric measurements was performed to document change in cranial configuration. Differences were considered significant if p<0.05. The medical photographs include frontal, posterior, right lateral, left lateral, and vertex (birdseye) views.

A total of 305 infants presented for postoperative treatment. Sixteen patients were excluded from the study due to noncompliance issues or for entering treatment more than four weeks after surgery was performed. Of the remaining 289 infants, nearly all forms of craniosynostosis were represented including 162 sagittal (56.1%), 44 metopic (15.2%), 38 unilateral coronal (13.1%), 12 bicoronal (4.2%), 15 unilateral lambdoid (5.2%), and 18 multiple suture synostosis (6.2%). A full range of surgical procedures were reported including minimally invasive endoscopic-assisted craniectomy, strip and extended strip craniectomy, and many variations of cranial vault remodeling. Mean entrance age was 6.9 months (range: 1.0-38.5 months), and mean treatment times was 3.3 months (range: 0.75-10.25 months). Statistically significant improvement (p=0.001) in cephalic index was documented with a mean improvement of 13.0% when considering all cases, and a 16.8% improvement when considering only sagittal synostosis. Pre and post-treatment photography demonstrated significant improvements in cranial configuration including correction of frontal bossing, bitemporal and biparietal narrowing, and occipital curvature.

The results of this investigation demonstrate that postoperative use of a cranial remodeling orthosis is effective in returning the head to a more normal configuration following surgery for craniosynostosis. This has been demonstrated to be true following all forms of synostosis as well as the various surgical procedures. Following surgery for sagittal synostosis (where the head is too long and narrow), the cranial remodeling bands maintained cranial length and directed the majority of growth in the lateral direction. (Figure 1) Conversely, following surgery for bicoronal synostosis, the cranial width was held, while the length was increased. In asymmetric deformities caused by unilateral coronal or unilateral lambdoid synostosis, use of cranial remodeling bands postoperatively improved symmetry of both the cranial vault and face. (Figure 2) In nearly all cases, some normalization or improvement of frontal bossing, biparietal and bitemporal narrowing, or improvement of the occipital contour were observed.5-7

Postoperative use of cranial remodeling bands worked equally well following all types of surgery. However, it is important that the design of these devices take into consideration not only the age of the infant and suture affected, but also the type and extent of the surgical procedure performed. It is now recognized that use of a postoperative molding helmet is critical to the success of the new minimally invasive endoscopic-strip craniectomy as it is the helmet that provides correction of head shape following surgery. For those surgeons who prefer cranial vault remodeling procedures, the cranial orthosis remains an important adjunct to surgery by providing stabilization and enhancing the surgical outcome.

References

Barringer WJ. The use of postoperative cranial orthoses in the management of craniosynostosis. JPO 2004;16(4):S56-S58
Persing JA, Nichter LS, Jane JA, Edgerton MT, Jr.: External cranial vault molding after craniofacial surgery. Ann Plast Surg 1986; 17(4):274-283.
Ham CK, Meyer SW: Skull molding caps: an adjunct to craniosynostosis surgery. Plast Reconstr Surg 1987; 80(5):737-742.
Joganic EF, Beals SP, Ripley CE, et al: Enhancement of craniofacial reconstruction by dynamic orthotic cranioplasty. In Marchac D (ed): Craniofacial Surgery VI: Proceedings of the Sixth International Congress of the International Society of Craniofacial Surgery.Bologna, Italy. Monduzzi Editore, 1995, pp. 151-153.
Seymour-Dempsey K, Baumgartner JE, Teichgraeber JF, et al: Molding helmet therapy in the management of sagittal synostosis. J Craniofac Surg 2002; 13(5):631-635.
Littlefield TR. Cranial remodeling devices: Treatment of deformational plagiocephaly and postsurgical applications. Seminars in Pediatric Neurology in press.
Pomatto JK, Calcaterra J, Hess RM, Kelly KM, Littlefield TR. Use of cranial remodeling bands following endoscopic-assisted craniectomy for sagittal synostosis. Submitted Journal of Neurosurgery: Pediatrics.

Figure 1
(A) Vertex view of a 2.25-month-old boy with sagittal synostosis (cephalic index, 67.4). (B) Postoperative/pre-band vertex view after endoscopic-assisted strip craniectomy. (cephalic index, 69.3) and (C) vertex view after 6 weeks in a cranial remodeling band (cephalic index, 81.0).

Figure 2
A 4.5-month-old boy after cranial vault remodeling surgery for left coronal synostosis. Front views at (A) entry and (B) after 8 weeks of treatment demonstrate nice correction of facial asymmetry. Vertex views at (C) entry and (D) exit demonstrate correction of left occipital flattening and forehead asymmetry. From Ref 5: Littlefield TR Seminars in Pediatric Neurosurgery.