Preliminary Results of a Prospective Study on Methods of Cranial Reconstruction

doi:10.1016/j.joms.2015.07.008

Journal of Oral and Maxillofacial Surgery

Volume 73, Issue 12, December 2015, Pages 2375-2378

https://doi.org/10.1016/j.joms.2015.07.008 Get rights and content

Purpose

Given its biological and anatomic features, autologous bone is the first choice for cranioplasty after bone decompression. When autologous bone is not available or must be replaced, surgeons can choose among various materials to create an alloplastic cranioplasty. The Italian Society for Neurosurgery promoted a prospective study conducted at 4 Italian neurosurgical units to compare different methods of cranioplasty and to assess the clinical results and incidence of complications.

Materials and Methods

Patients older than 14 years who underwent repositioning of autologous bone or 3-dimensional image-guided reconstruction with prostheses made of an alloplastic material (polyetheretherketone, polymethylmethacrylate, or hydroxyapatite) after cranial decompression were enrolled prospectively from January 2008 through December 2013. The collected data included the material used to produce the prosthesis, the type of cranioplasty (primary or secondary), and complications that required surgical removal of the prosthesis (eg, infection, bone resorption, and fracture of the cranioplasty).

Results

Ninety-six patients met the study criteria. Fifty cases were reconstructed with hydroxyapatite, 31 with bone, 13 with polymethylmethacrylate, and 2 with polyetheretherketone. Seven patients (7.3%) developed complications related to the cranioplastic implant that required reoperation. These complications included infection (4 cases), bone resorption (2 cases), and fracture of the cranioplastic prosthesis (1 case). Statistical analysis showed a higher rate of complications with the use of autologous bone versus alloplastic materials (P = .03). Owing to the limited number of cases, no statistically meaningful complication was seen among the different alloplastic materials or when the cranioplastic implant was placed as secondary treatment.

Conclusions

These data and those of other reports suggest that cranioplasty conducted using alloplastic 3-dimensional reconstruction materials have a lower rate of complications than those conducted using autologous bone.

Section snippets

Data Collection

Data from neurosurgical registries at 4 different hospitals in Italy (University Hospital of Parma, ASMN Reggio Emilia, Bellaria Hospital of Bologna, and Cannizzaro Hospital of Catania) were collected prospectively from 2008 through 2013. The study was approved by the local institutional review board and ethical committee of the principal investigator's center at the start of the study. Patients eligible for the study underwent cranioplasties performed with 4 different materials: autologous

Results

Ninety-six patients met the study criteria: 31 underwent a cranioplasty with autologous bone, 50 with HA, and 15 with synthetic materials (13 with PMMA and 2 with PEEK). All alloplastic cranioplasties were custom made using 3-dimensional computed tomographic reconstruction techniques. Clinical and radiological data are presented in Table 1. Among patients in the alloplastic cranioplasty group, 39 underwent placement of a primary cranioplasty (27 with HA and 12 with PMMA or PEEK) and 26 (23 with

Discussion

Patients older than 14 years were chosen deliberately because the number of complications in pediatric cranioplasty cases, especially those requiring bone reconstruction, is larger than in adult cases.⁴ In general, in Italy, the first choice for cranioplasty is the repositioning of patient's bone when available. This prospective study showed a higher rate of complications in patients with autologous cranioplasties. It has to be noted that all bone flaps were sent to a regional bone bank

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Y.K. Cheng et al.
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There are more references available in the full text version of this article.

Cited by (46)

Cranioplasty is not required in the reconstruction of small combined scalp and calvarial defects
2024, Journal of Plastic, Reconstructive and Aesthetic Surgery
Treatment of scalp malignancies may include the need for craniectomy. The decision to perform cranioplasty is not straightforward and is frequently subjective. The purpose of this study was to assess the clinical outcomes after reconstruction of complex scalp and calvarial defects by comparing patients with and without cranioplasty.
Retrospective review of the clinical records of a consecutive series of patients who underwent scalp soft tissue reconstruction after craniectomy for malignancy or osteoradionecrosis between 2014 and 2022 at Royal Melbourne Hospital was conducted. Demographics, previous treatments, surgical details, and post-operative complications were assessed. Traumatic injuries and decompressive craniectomies were excluded. Minimum follow-up of 6 months.
Thirty-seven patients were included in the study. Indications for surgery included skin malignancies, osteoradionecrosis, or both. There was one reconstructive failure (in the non-cranioplasty group). Infection and metalware exposure were common complications in patients who underwent cranioplasty (38.5%). No patient developed neurological symptoms subsequent to craniectomy. One patient needed revision surgery due to esthetic reasons (cranioplasty group). Transposition flaps were associated with more complications and revision procedures.
Combined scalp and calvarial defects pose a difficult reconstructive challenge. Stable soft tissue coverage is more reliably achieved with free flap reconstruction. Cranioplasty is not always mandatory and should be reserved for cases with a very large bony defect or when the defect is located in a cosmetically sensitive area.
Comparison of Perioperative and Long-term Outcomes Following PEEK and Autologous Cranioplasty: A Single Institution Experience and Review of the Literature
2023, World Neurosurgery
Three-dimensionally (3D) printed polyether-ether-ketone (PEEK) implants are a relatively novel option for cranioplasty that have recently gained popularity. However, there is ongoing debate with respect to material efficacy and safety compared to autologous bone grafts. The purpose of this study was to offer our institution’s experience and add to the growing body of literature.
A single-institution retrospective analysis of patients undergoing cranioplasties between 2016 and 2021. Patients were divided into PEEK and autologous cranioplasty cohorts. Parameters of interest included patient demographics as well as perioperative (<3 months postoperative) and long-term outcomes (>3 months postoperative). A P value < 0.05 was considered statistically significant.
A total of 31 patients met inclusion criteria (PEEK: 15, Autologous: 16). Mean age of total cohort was 48.9 years (range 19–82 years). Modified Frailty Index (mFI) revealed greater rate of comorbidities among the Autologous group (P = 0.073), which was accounted for in statistical analyses. Multiple logistic regression model revealed significantly higher rate of surgical site infection in the Autologous cohort (31.3% vs. 0%, P = 0.011). Minor complications were similar between groups, while the Autologous group experienced significantly more major postoperative complications (50%) versus PEEK (13.3%) (P = 0.0291). Otherwise perioperative and long term complication profiles were similar between groups. Additionally, generalized linear model demonstrated both cohorts had similar mean hospital length of stay (LoS) (Autologous: 16.1 vs. PEEK: 10.7 days).
PEEK cranioplasty implants may offer more favorable perioperative complication profiles with similar long-term complication rates and hospital LoS compared to autologous bone implants. Future studies are warranted to confirm our findings in larger series, and further examine the utility of PEEK in cranioplasty.
Materials Used in Cranial Reconstruction: A Systematic Review and Meta-Analysis
2022, World Neurosurgery
Citation Excerpt :
A systematic search of the PubMed/MEDLINE database yielded 16,072 articles (Figure 1). Of these studies, 35 met inclusion criteria for this meta-analysis, including 3 randomized controlled trials, 31 retrospective single-center studies, and 1 multicenter prospective cohort study.4,5,7,11,18-49 In aggregate, 4191 cranioplasties were performed across all studies.
Cranioplasty is a common neurologic procedure, with complication rates ranging from 20% to 50%. It is hypothesized that the risks of various complications are affected by which material is used for cranioplasty.
To evaluate the literature comparing rates of complications after cranioplasty using different materials including autologous bone, hydroxyapatite, methyl methacrylate, demineralized bone matrix, polyetheretherketone, titanium, or composite materials.
The PubMed/MEDLINE database was searched for relevant articles published between 2010 and 2020. After screening, 35 articles were included. Outcomes included infection, wound problems, poor cosmesis, overall complications, duration of surgery, and length of stay. For each outcome, a frequentist network meta-analysis was conducted to compare materials used.
The risk of infection was 1.62 times higher when methyl methacrylate was used compared with autologous bone (relative risk, 1.62; 95% confidence interval [CI], 1.07–2.45). Length of stay after cranioplasty was on average 3.62 days shorter when titanium was used compared with autologous bone (95% CI, 6.26 to –0.98). The networks constructed for other outcomes showed moderate to substantial between-study heterogeneity, wide CIs, and no significant differences between materials.
The quality of existing literature on this topic is relatively poor, almost exclusively comprising single-center retrospective studies. There is not strong enough evidence available to make comprehensive conclusions regarding the risk profiles of various cranioplasty materials across multiple outcomes. Prospective randomized trials are necessary to confirm the significant results found in this analysis and to further elucidate the differential risks of various cranioplasty materials.
Customized polyetheretherketone (PEEK) implants are associated with similar hospital length of stay compared to autologous bone used in cranioplasty procedures
2022, Journal of the Neurological Sciences
Cranioplasty is the surgical repair of cranial defects. Throughout its history, a number of different materials have been used, however, there is still no consensus on which material or method is best. The purpose of this study was to analyze the viability of polyetheretherketone (PEEK) cranioplasty to autologous cranioplasty modalities.
A single-institution retrospective analysis of patients undergoing cranioplasties was performed. Patients were divided to PEEK and autologous cranioplasty cohorts. Parameters of interest included patient demographics and perioperative outcomes. A p-value <0.05 was considered statistically significant.
A total of 66 patients met the inclusion criteria (PEEK: 22, autologous: 44). There were 36 males (54.5%) and 30 females (45.5%). Mean age of the entire cohort was 51.7 years (range 19–85 years). Baseline demographics were similar in both cohorts as measured by the modified frailty index (mFI) (p = 0.67). Univariate analysis revealed a significantly longer hospital length of stay (LoS) associated with the autologous group (p = 0.02). However, multivariate analysis did not yield such an association (p = 0.06) after controlling for mFI. Although the individual postoperative complication rates were similar between the two cohorts, autologous cranioplasty was associated with a significantly higher rate of total postoperative complications (65.9% vs 36.4%, p = 0.02).
Overall, PEEK biomaterials may offer a superior complication profile with similar hospital LoS compared to autologous bone implants used in cranioplasty. Future studies are warranted to validate our findings and further evaluate the utility of PEEK in cranioplasty.
Management of infected hydroxyapatite cranioplasty: Is salvage feasible?
2022, Brain and Spine
The use of hydroxyapatite cranioplasties has grown progressively over the past few decades. The peculiar biological properties of this material make it particularly suitable for patients with decompressive craniectomy where bone reintegration is a primary objective. However, hydroxyapatite infection rates are similar to those of other reconstructive materials.
We investigated if infected hydroxyapatite implants could be saved or not.
We present a consecutive series over a 10-year period of nine patients treated for hydroxyapatite cranioplasty infection. Clinical and radiological data from admission and follow-up, photo and video material documenting the different phases of infection assessment and treatment, and final outcomes were retrospectively reviewed in an attempt to identify the best options and possible pitfalls in a case-by-case decision-making process.
Five unilateral and four bifrontal implants became infected. Wound rupture with cranioplasty exposure was the most common presentation. At revision, all implants were ossified, requiring a new craniotomy to clean the purulent epidural collections. The cranioplasty was fully saved in one hemispheric and 2 bifrontal implants and partially saved in the remaining 2 bifrontal implants. A complete cranioplasty removal was needed in the other 4 cases, but immediate cranial reconstruction was possible in 2. Skin defects were covered by free flaps in 3 cases. Four patients underwent adjunctive hyperbaric therapy, which was effective in one case.
In our experience, infected hydroxyapatite cranioplasty management is complex and requires a multidisciplinary approach. Salvage of a hydroxyapatite implant is possible under specific circumstances.
Security and reliability of CUSTOMBONE cranioplasties: A prospective multicentric study
2021, Neurochirurgie
Repairing bone defects generated by craniectomy is a major therapeutic challenge in terms of bone consolidation as well as functional and cognitive recovery. Furthermore, these surgical procedures are often grafted with complications such as infections, breaches, displacements and rejections leading to failure and thus explantation of the prosthesis.
To evaluate cumulative explantation and infection rates following the implantation of a tailored cranioplasty CUSTOMBONE prosthesis made of porous hydroxyapatite. One hundred and ten consecutive patients requiring cranial reconstruction for a bone defect were prospectively included in a multicenter study constituted of 21 centres between December 2012 and July 2014. Follow-up lasted 2 years.
Mean age of patients included in the study was 42 ± 15 years old (y.o), composed mainly by men (57.27%). Explantations of the CUSTOMBONE prosthesis were performed in 13/110 (11.8%) patients, significantly due to infections: 9/13 (69.2%) (p < 0.0001), with 2 (15.4%) implant fracture, 1 (7.7%) skin defect and 1 (7.7%) following the mobilization of the implant. Cumulative explantation rates were successively 4.6% (SD 2.0), 7.4% (SD 2.5), 9.4% (SD 2.8) and 11.8% (SD 2.9%) at 2, 6, 12 and 24 months. Infections were identified in 16/110 (14.5%): 8/16 (50%) superficial and 8/16 (50%) deep. None of the following elements, whether demographic characteristics, indications, size, location of the implant, redo surgery, co-morbidities or medical history, were statistically identified as risk factors for prosthesis explantation or infection.
Our study provides relevant clinical evidence on the performance and safety of CUSTOMBONE prosthesis in cranial procedures. Complications that are difficulty incompressible mainly occur during the first 6 months, but can appear at a later stage (> 1 year). Thus assiduous, regular and long-term surveillances are necessary.

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: Drs Iaccarino and Servadei received limited grants for educational purposes from Codman Co. Dr Viaroli had a consultant role for 16 months at Finceramica.

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Craniomaxillofacial traumaPreliminary Results of a Prospective Study on Methods of Cranial Reconstruction

Purpose

Materials and Methods

Results

Conclusions

Section snippets

Data Collection

Results

Discussion

Failure of autologous bone-assisted cranioplasty following decompressive craniectomy in children and adolescents

J Neurosurg

Analyses of the factors influencing bone graft infection after delayed cranioplasty

Acta Neurochir (Wien)

Factors affecting graft infection after cranioplasty

J Clin Neurosci

Craniomaxillofacial trauma
Preliminary Results of a Prospective Study on Methods of Cranial Reconstruction