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

Frassanito, Paolo; Tamburrini, Gianpiero; Massimi, Luca; Rocco, Concezio Di; Nataloni, Angelo; Fabbri, Giampietro; Caldarelli, Massimo

doi:10.1007/s00701-014-2254-y

Cited by 28 publications

(14 citation statements)

References 22 publications

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“…They had a comparable reoperation rate of 20.8% with implant removal. 7 There was no significant difference with the titanium group, which had 7 cases of reoperation (29.2%) and 3 cases of explantation. In 2006, Eufinger et al showed a comparable reoperation rate of 21% and secondary implant removal rate in 8.4% for titanium.…”

Section: Discussionmentioning

confidence: 74%

Cranioplasty using custom-made hydroxyapatite versus titanium: a randomized clinical trial

Lindner

Schlothofer-Schumann

Kern

et al. 2017

JNS

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OBJECTIVE Cranioplasty is routinely performed in neurosurgery. One of its underestimated problems is the high postoperative complication rate of up to 40%. Due to the lack of good prospective studies and the small number of patients (5-20 each year) who receive alloplastic materials, decisions in favor or against a certain material are based on subjective empirical or economic reasons. The main goal of this study-the first prospective, randomized multicenter study in Germany-of custom-made titanium and hydroxyapatite (HA) implants was to compare local and systemic infections related to the implant within the first 6 months after implantation. Secondary objectives included comparing the reoperation rate, the complication rate, clinical and neurological outcomes, and health-related quality of life. METHODS The study included patient screening and randomization at 6 to 8 weeks before operation; pre-, intra-, and postoperative documentation until discharge; and postoperative follow-ups after 1 and 6 months. Approval for the study was obtained from the local ethics committee. RESULTS A total of 52 patients were included in the study. The rate of local implant-associated wound infection in the HA group was 2 of 26 (7.7%) patients and 5 of 24 (20.8%) patients in the titanium group (p = 0.407). Systemic inflammation within 6 months after operation affected none of the patients in the HA group and 4 of 24 (37.5%) patients in the titanium group (p = 0.107). In both groups, 7 patients required reoperation after the 6-month follow-up (26.9% of the HA group and 29.2% of the titanium group; not significant). Reoperation with an explantation was necessary in 3 patients in each group (11.5% of the HA group and 12.5% of the titanium group; not significant). The results demonstrated a significantly higher number of epidural hematomas in the HA group in comparison with none in the titanium group. Altogether, 46 adverse events were found in 27 patients (54%). An improvement in the neurological outcome after 6 months was experienced by 43% of the patients in the HA group and 26.3% of the patients in the titanium group (p = 0.709). CONCLUSIONS The study emphasizes that cranioplasty is a high-risk intervention. In comparison with titanium, HA shows benefits in terms of the infection rate and the neurological outcome, but at the same time has a higher postoperative risk for epidural hematoma. Depending on the individual conditions, both materials have their place in future cranioplasty therapies. Clinical trial registration no.: NCT00923793 ( clinicaltrials.gov ).

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Section: Discussionmentioning

confidence: 74%

Cranioplasty using custom-made hydroxyapatite versus titanium: a randomized clinical trial

Lindner

Schlothofer-Schumann

Kern

et al. 2017

JNS

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“…However, homologous bone for pediatric cranioplasty did not gain wide acceptance owing to the relative rarity of large defects in very young children [5, 13, 15, 16]. In 2010, Brevi et al [13] reported a 33-month-old patient with Ewing’s sarcoma whose residual large frontal defect was repaired using autologous parietal bone, while the donor site was reconstructed using cadaveric bone.…”

Section: Discussionmentioning

confidence: 99%

“…Osteoinductive solutions should theoretically be preferred since the skull is still growing. This necessity is particularly important in infants because most cranial vault growth takes place within 30 months of age [2-5]. Indeed, acrylic resins have been satisfactorily used in some cases [3, 6], but several authors have reported high rates of midterm failure [2, 4, 7, 8].…”

Section: Introductionmentioning

confidence: 99%

“…Indeed, acrylic resins have been satisfactorily used in some cases [3, 6], but several authors have reported high rates of midterm failure [2, 4, 7, 8]. In patients of that age, cryopreserved bone autografts present the highest rates of failure [3, 4, 9, 10] and customized bioceramics may not be ideal because the receiving skull may be too thin or because of the flap geometry and curvature [1, 5]. Autologous bone from the hip, ribs, or vault may be used to reconstruct small and medium sized skull defects.…”

Section: Introductionmentioning

confidence: 99%

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Transplant of Adult Bone for Reconstruction of a Large Post-Traumatic Cranial Defect in a Very Young Baby

2019

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Large cranial defects in very young patients are challenging. The ideal material for cranioplasty in this age group has not yet been identified. Cryopreserved autologous bone presents very high rates of failures, acrylic resins pose a number of compatibility problems, bioceramics may be contraindicated, and autografts may be not adequate for repair of large defects. We present an 18-month-old baby with a large post-traumatic cranial defect which was repaired by assembling a new bone flap on a sterile stereolithographic 3-D model. This customized newly assembled flap consisted of a scaffold of autologous bone (from vault duplication) sustaining 2 large grafts of homologous cadaveric bone. It was adequately modeled and contoured on the 3-D model using metallic plates and screws. Immediately after implantation on the skull, the metallic devices were progressively replaced by reabsorbable material, thus maintaining the previously obtained flap profile. In this paper we detail this original technique which was developed to manage this specific patient.

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“…Nonetheless, it presents several drawbacks, including the brittle nature, the low tensile strength, and the high infection rates [92]. Cranial implants based on macroporous hydroxyapatite have been increasingly used with satisfactory results in children [93,94]. However, these implants are not indicated under two years of age, so that a real solution for the repair of large size cranial defects in this age group is actually still lacking.…”

Section: Tissue Engineering Strategiesmentioning

confidence: 99%

Personalized Bone Reconstruction and Regeneration in the Treatment of Craniosynostosis

et al. 2021

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Craniosynostosis (CS) is the second most prevalent craniofacial congenital malformation due to the premature fusion of skull sutures. CS care requires surgical treatment of variable complexity, aimed at resolving functional and cosmetic defects resulting from the skull growth constrain. Despite significant innovation in the management of CS, morbidity and mortality still exist. Residual cranial defects represent a potential complication and needdedicated management to drive a targeted bone regeneration while modulating suture ossification. To this aim, existing techniques are rapidly evolving and include the implementation of novel biomaterials, 3D printing and additive manufacturing techniques, and advanced therapies based on tissue engineering. This review aims at providing an exhaustive and up-to-date overview of the strategies in use to correct these congenital defects, focusing on the technological advances in the fields of biomaterials and tissue engineering implemented in pediatric surgical skull reconstruction, i.e., biodegradable bone fixation systems, biomimetic scaffolds, drug delivery systems, and cell-based approaches.

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

Cited by 28 publications

References 22 publications

Cranioplasty using custom-made hydroxyapatite versus titanium: a randomized clinical trial

Cranioplasty using custom-made hydroxyapatite versus titanium: a randomized clinical trial

Transplant of Adult Bone for Reconstruction of a Large Post-Traumatic Cranial Defect in a Very Young Baby

Personalized Bone Reconstruction and Regeneration in the Treatment of Craniosynostosis

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