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

Journal of Neurosurgery

Jan 2017 / Vol. 126 / No. 1 / Pages 175-183

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

1Department of Neurosurgery, Leipzig University, Leipzig; 2Department of Neurosurgery, BG Clinic Bergmannstrost, Halle; and 3Department of Neurosurgery, Nuremberg Hospital, Nuremberg, Germany
ABBREVIATIONS AE = adverse event; CCT = cranial computed tomography; GCS = Glasgow Coma Scale; HA = hydroxyapatite; KPS = Karnofsky Performance Scale; mGOS = modified Glasgow Outcome Scale; SAE = significant AE; SF-36 = 36-Item Short Form Health Survey.

INCLUDE WHEN CITING Published online February 26, 2016; DOI: 10.3171/2015.10.JNS151245.

Correspondence Dirk Lindner, Department of Neurosurgery, University Hospital Leipzig, Liebigstrasse 20, Leipzig D-04103, Germany. email: .
Related Articles
By Keywords:
cranioplasty, titanium, hydroxyapatite, prospective study

Abstract

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).

Cited by

  1. Anne Morice, MD, Frédéric Kolb, MD, Arnaud Picard, MD, PhD, Natacha Kadlub, MD, PhD, and Stéphanie Puget, MD, PhD. (2017) Reconstruction of a large calvarial traumatic defect using a custom-made porous hydroxyapatite implant covered by a free latissimus dorsi muscle flap in an 11-year-old patient. Journal of Neurosurgery: Pediatrics 19:1, 51-55. . Online publication date: 1-Jan-2017. Abstract | Full Text | PDF (5493 KB) 
  2. Raphael Carloni, Christian Herlin, Benoit Chaput, Antoine De Runz, E. Watier, NicolasBertheuil. (2016) Scalp Tissue Expansion Above a Custom-Made Hydroxyapatite Cranial Implant to Correct Sequelar Alopecia on a Transposition Flap. World Neurosurgery 95, 616.e1-616.e5. . Online publication date: 1-Nov-2016. [CrossRef]

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