The Efficacy of Custom-Made Porous Hydroxyapatite Prostheses for                     Cranioplasty: Evaluation of Postmarketing Data on 2697 Patients

Stefini, Roberto; Zanotti, Bruno; Nataloni, Angelo; Martinetti, Roberta; Scafuto, Michele; Colasurdo, Marco; Tampieri, Anna

doi:10.5301/jabfm.5000211

Cited by 24 publications

(25 citation statements)

References 20 publications

(18 reference statements)

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“…In this respect, the implantation of bioactive apatitic pastes able to completely transform into apatite while maintaining a microporous structure can be elective for bone regeneration, due to the extensive colonization by new bone that can also improve the mechanical performance of the implant over time, as already evidenced in previous studies [52,53]. This is particularly relevant in the case of young and still physically active patients, for whom effective bone regeneration is of paramount importance to restore the physiological bone functionality.…”

Section: Discussionmentioning

confidence: 89%

Novel Osteointegrative Sr-Substituted Apatitic Cements Enriched with Alginate

et al. 2016

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The present work describes the synthesis of novel injectable, self-setting bone cements made of strontium-substituted hydroxyapatite (Sr-HA), obtained by single-phase calcium phosphate precursors doped with different amounts of strontium and enriched with alginate. The addition of alginate improved the injectability, cohesion, and compression strength of the cements, without affecting the hardening process. A Sr-HA cement exhibiting adequate hardening times and mechanical strength for clinical applications was further tested in vivo in a rabbit model, in comparison with a commercial calcium phosphate cement, revealing the maintenance of biomimetic composition and porous microstructure even after one month in vivo, as well as enhanced ability to induce new bone formation and penetration.

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Section: Discussionmentioning

confidence: 89%

Novel Osteointegrative Sr-Substituted Apatitic Cements Enriched with Alginate

et al. 2016

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“…Sample size and power calculations were based on a comparison of the postoperative infection rates when Fisher's exact test was used. A randomization ratio of 1:1 and sample size of 77 patients per arm would ensure a significance level of 5% and a power of 80% to test the null hypothesis of 15% postoperative infections in both treatment arms against the alternative of a 13% lower rate of infections when HA implants 25 were used. Estimations of power with respect to the major secondary end points of reoperation and explantation are based on literature references, which report 10% to 13% for the former and 8% for the latter when titanium implants were used 8 in comparison with 0.5% for both reoperation and explantation for HA.…”

Section: Discussionmentioning

confidence: 99%

“…The primary objective was to compare local implantassociated infections and/or systemic infections in both study arms within the first 6 months after implantation. An infection rate of 15% 25 was assumed for titanium in comparison with 2% for HA. 8 Further secondary objectives included 1) comparison of the rate of reoperation with and without explantation; 2) comparison of the patients' neurological and clinical status; 3) comparison of surgery time, anesthesia time, complications, and CT scans; 4) comparison of health-related quality of life on the 36-Item Short Form Health Survey (SF-36) after cranioplasty; 5) comparison of modified Glasgow Outcome Scale (mGOS) score, 18 Karnofsky Performance Scale (KPS) score, and overall impression; 6) group comparisons based on the cosmetic results, duration of hospital stay, and treatment costs; and 7) comparison of temperature sensitivity (heating and cooling) at 6 months after implantation.…”

Section: Methods Hypothesismentioning

confidence: 99%

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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“…Recently, custom-made prostheses for cranioplasty printed with three-dimensional printers are on market (Table 2, Figure 1). 48)…”

Section: Bone Substitute For Cranioplastymentioning

confidence: 99%

“…There are many reports about new substitutes. The difference of the clinical outcome between synthetic materials and autologous bone graft in cranioplasty is very small 3435394048). Some authors report lower complication with synthetic materials 825262728).…”

Section: Cost Effectiveness Of Autologous Skull Flap In Koreamentioning

confidence: 99%

Review of Cranioplasty after Decompressive Craniectomy

Cho

Kang

2017

Korean J Neurotrauma

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Cranioplasty is an in evitable operation conducted after decompressive craniectomy (DC). The primary goals of cranioplasty after DC are to protect the brain, achieve a natural appearance and prevent sinking skin flap syndrome (or syndrome of the trephined). Furthermore, restoring patients' functional outcome and supplementing external defects helps patients improve their self-esteem. Although early cranioplasty is preferred in recent year, optimal timing for cranioplasty remains a controversial topic. Autologous bone flaps are the most ideal substitute for cranioplasty. Complications associated with cranioplasty are also variable, however, post-surgical infection is most common. Many new materials and techniques for cranioplasty are introduced. Cost-benefit analysis of these new materials and techniques can result in different outcomes from different healthcare systems.

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The Efficacy of Custom-Made Porous Hydroxyapatite Prostheses for Cranioplasty: Evaluation of Postmarketing Data on 2697 Patients

Cited by 24 publications

References 20 publications

Novel Osteointegrative Sr-Substituted Apatitic Cements Enriched with Alginate

Novel Osteointegrative Sr-Substituted Apatitic Cements Enriched with Alginate

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

Review of Cranioplasty after Decompressive Craniectomy

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