Post-marketing surveillance of CustomBone Service implanted in children under 7 years old

Cranioplasty, one of the oldest surgical procedures used to repair cranial defects, has undergone many revolutions over time to find the ideal material to improve patient prognosis. Cranioplasty offers cosmetic and protective benefits for patients with cranial defects. The first primitive cranioplasty procedures date back to 7000 bc and used metal and gourds to repair cranial defects. Cranioplasty was first documented by Fallopius who described repair using gold plates; the first bone graft was documented by van Meekeren. The first significant improvement for this procedure began with experimentation involving bone grafts in the late 19th century as a more natural approach for repairing cranial defects. The next impetus for advancement came because of wartime injuries incurred during World Wars I and II and involved experimentation with synthetic materials to counter the common complications associated with bone grafts. Methyl methacrylate, hydroxyapatite, ceramics, and polyetheretherketone implants among other materials have since been researched and used. Research now has shifted toward molecular biology to improve the ability of the patient to regenerate bone using bone growth factors. This paper reviews the evolution of materials used over time in addition to the various advantages and pitfalls associated with each change. It is important for neurosurgeons to be mindful of how these techniques have evolved in order to gain a better understanding of this procedure and how it has been adapted.

The authors have routinely performed primary autologous cranioplasty to repair skull defects after decompressive craniectomy. The high rates of subsequent bone resorption occurring in children prompted this study. In an institutional review, the authors identified 40 (32 male and eight female) children and adolescents ranging from 4 months to 19 years of age in whom autologous cranioplasty was performed after decompressive craniectomy. The defect surface area ranged from 14 to 147 cm2. In all cases, the bone was fresh frozen at the time of the decompression. Symptomatic bone resorption subsequently occurred in 20 children (50%) in all of whom reoperation was required. The incidence of bone resorption significantly correlated with an increased skull defect area (p < 0.025). No significant correlation was found with age, sex, or anatomical location of the skull defect, number of fractured bone fragments, presence of a shunt, cause for decompressive craniectomy, method of duraplasty, or interval between the craniectomy and the cranioplasty. Reoperation to repair the resorbed autologous bone was performed 2 to 76 months after the initial procedure. The use of autologous bone to reconstruct skull defects in pediatric patients after decompressive craniectomy is associated with a high incidence of bone resorption. The use of autologous bone should be reevaluated in light of the high rate of reoperation in this pediatric population.

Osteoprogenitor cells combined with supportive biomaterials represent a promising approach to advance the standard of care for bone grafting procedures. However, this approach faces challenges, including inconsistent bone formation, cell survival in the implant, and appropriate biomaterial degradation. We have developed a collagen-hydroxyapatite (HA) scaffold that supports consistent osteogenesis by donor-derived osteoprogenitors, and is more easily degraded than a pure ceramic scaffold. Herein, the material properties are characterized as well as cell attachment, viability, and progenitor distribution in vitro. Furthermore, we examined the biological performance in vivo in a critical-size mouse calvarial defect. To aid in the evaluation of the in-house collagen-HA scaffold, the in vivo performance was compared with a commercial collagen-HA scaffold (Healos(®) , Depuy). The in-house collagen-HA scaffold supported consistent bone formation by predominantly donor-derived osteoblasts, nearly completely filling a 3.5 mm calvarial defect with bone in all samples (n = 5) after 3 weeks of implantation. In terms of bone formation and donor cell retention at 3 weeks postimplantation, no statistical difference was found between the in-house and commercial scaffold following quantitative histomorphometry. The collagen-HA scaffold presented here is an open and well-defined platform that supports robust bone formation and should facilitate the further development of collagen-hydroxyapatite biomaterials for bone tissue engineering.