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Post-marketing surveillance of CustomBone Service implanted in children under 7 years old
Paolo Frassanito1, Gianpiero Tamburrini, Luca Massimi
1Pediatric Neurosurgery, Catholic University Medical School, Largo Agostino Gemelli, 8, 00168, Rome, Italy, paolo.frassanito@gmail.com.
Insights
The CustomBone Service bioceramic implant showed a higher failure rate in children under 7 years old compared to older patients. However, it remains a viable option for cranial repair in this age group when carefully considered.
Area of Science:
- Biomaterials Science
- Pediatric Surgery
- Neurosurgery
Background:
- The CustomBone Service is a bioceramic implant for cranial repair.
- Clinical data for its use in children under 7 years old is limited.
- This study addresses the outcome of CustomBone Service in this specific pediatric age group.
Purpose of the Study:
- To investigate the safety and efficacy of the CustomBone Service in children under 7 years of age.
- To compare the outcomes in this age group with existing data for adults and older children.
- To evaluate the complication rates associated with CustomBone Service in young children.
Main Methods:
- A surveillance study was conducted involving 28 children under 7 years old (2.5-6 years).
- The CustomBone Service implant was used for cranial repair across 16 international hospitals between July 2006 and May 2013.
- Data from 23 children (24 prostheses) with a minimum 1-year follow-up were analyzed.
Main Results:
- The overall failure rate of the CustomBone Service in children under 7 was 20.8%.
- Complications included implant rupture (3.8%), fractures (3 cases), and exposure/infection (2 cases), all requiring device removal.
- Cranial defects were primarily due to trauma (54.2%) and malformations (37.5%).
Conclusions:
- The CustomBone Service exhibits a higher failure rate in children under 7 years old compared to older populations.
- Despite higher complication rates, CustomBone Service can be considered a valid option for young children due to lower long-term complication risks compared to alternative materials.
- Surgeons must carefully evaluate the indication for CustomBone Service in toddlers on a case-by-case basis due to the material's specific properties.
Background:
The CustomBone Service is a bioceramic implant suitable for cranial repair in both adults and children, although there are no clinical data about its use in children under 7 years of age. This surveillance study investigates the outcome in this age group.
Method:
Twenty-eight children under 7 years old (range, 2.5-6 years) received CustomBone Service from July 2006 to May 2013 in 16 international hospitals. Data of 23 children (12 males and 11 females), harboring 24 prosthesis, were available with a minimum follow-up of 1 year.
Findings:
Sites of the cranial defect were frontal or parietal (20.8 % each), parieto-temporal (16.7 %), fronto-parietal or occipital (12.5 % each), fronto-parieto-temporal or fronto-temporal (8.3 % each). Initial diseases were trauma (54.2 %), malformation (37.5 %), or tumor of the bone/skin (8.3 %). Rupture of the implant occurred in a single case during the implant (1/26 surgeries, 3.8 %) and the cranial repair was achieved by means of the back-up prosthesis. Five adverse events were registered during the follow-up period consisting of three cases of fracture and two of exposure/infection of the prosthesis. All cases required the removal of the device (20.8 %).
Conclusions:
The failure rate of CustomBone Service under 7 years of age was higher than reported in adults and children over 7 years old (20.8 vs. 3.8 %), However, CustomBone Service may be considered a valid option under 7 years old since other materials are burdened by more significant rates of complications in the long-term period. Due to specific properties of this material, indication to CustomBone Service in toddlers should be carefully evaluated by the surgeon on a case-by-case basis.