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

Dirk Lindner1, Kathrin Schlothofer-Schumann1, Bodo-Christian Kern2

  • 1Department of Neurosurgery, Leipzig University, Leipzig.

Journal of Neurosurgery
|February 27, 2016
PubMed
Summary

This study compared custom-made titanium and hydroxyapatite (HA) implants for cranioplasty, finding HA associated with lower infection rates and better neurological outcomes, though with a higher risk of epidural hematoma.

Keywords:
AE = adverse eventCCT = cranial computed tomographyGCS = Glasgow Coma ScaleHA = hydroxyapatiteKPS = Karnofsky Performance ScaleSAE = significant AESF-36 = 36-Item Short Form Health SurveycranioplastyhydroxyapatitemGOS = modified Glasgow Outcome Scaleprospective studytitanium

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Area of Science:

  • Neurosurgery
  • Biomaterials Science
  • Medical Engineering

Background:

  • Cranioplasty is a common neurosurgical procedure with high complication rates (up to 40%).
  • Limited prospective data exists for alloplastic materials, leading to subjective material selection.
  • Custom-made implants offer personalized solutions for cranial reconstruction.

Purpose of the Study:

  • To compare local and systemic infections within 6 months for custom-made titanium vs. hydroxyapatite (HA) cranioplasty implants.
  • To evaluate secondary outcomes including reoperation rates, complications, neurological function, and quality of life.

Main Methods:

  • Prospective, randomized, multicenter study in Germany.
  • Inclusion of 52 patients undergoing cranioplasty with either titanium or HA implants.
  • Follow-up at 1 and 6 months post-operation, including clinical and neurological assessments.

Main Results:

  • Hydroxyapatite (HA) group showed lower local implant-associated infection rates (7.7% vs. 20.8%) and no systemic inflammation compared to the titanium group (37.5%).
  • Reoperation rates were similar (26.9% HA vs. 29.2% titanium), with similar explantation rates.
  • The HA group experienced a higher incidence of epidural hematomas; however, more patients in the HA group showed improved neurological outcomes (43% vs. 26.3%).

Conclusions:

  • Cranioplasty remains a high-risk procedure, regardless of material used.
  • Hydroxyapatite (HA) implants demonstrate potential advantages in reducing infection and improving neurological recovery compared to titanium.
  • Both titanium and HA have distinct risk profiles (e.g., epidural hematoma for HA) and should be considered based on individual patient factors.