Feasibility and Safety of Intraoperative Application of Porous Hydroxyapatite/Collagen Composites to Prevent Craniotomy Defects: A Pilot Study

Oper Neurosurg. 2025 Nov 10. doi: 10.1227/ons.0000000000001847. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVES: Porous hydroxyapatite/collagen composite (HAp/Col) is a bioresorbable bone substitute composed of nanoscale HAp and porcine type 1 collagen. The aim of this study was to determine the feasibility and safety of porous HAp/Col for intraoperative implantation to prevent bone defects after craniotomy over the long term, compared with autogenous bone powder (ABP).

METHODS: Patients with intraoperative bone defects during open surgery were enrolled. Porous HAp/Col and ABP grafts were implanted simultaneously at different sites within the same surgical field of each patient to control for individual variability. Computed tomography was performed preoperatively, on the day after surgery, and at 12 months postoperatively. Effective osteogenesis was defined as a computed tomography value > 200 Hounsfield units. Bone fusion was assessed by cortical continuity between the implant and surrounding bone. Esthetic outcomes, including skin depression, and adverse events were evaluated at 12 months. All statistical testing was completed using JMP Pro version 17.2.0, with significance defined as P < .05.

RESULTS: Thirty-one patients were enrolled. The procedure was successfully and safely completed in all the patients. Four cases in the porous HAp/Col group and 1 case in the ABP group exhibited Hounsfield units values < 200 (P = .083). Bone fusion was observed in 25 cases in the porous HAp/Col group and in 28 cases in the ABP group (P = .180). Skin depression was observed in 1 case in the porous HAp/Col group and in 2 cases in the ABP group (P = .317). No mortalities or severe postoperative complications were observed.

CONCLUSION: This study demonstrated the feasibility and safety of intraoperative implantation of porous HAp/Col as a bone filler to prevent bone defects caused by craniotomy. Porous HAp/Col is an absorbable artificial bone that can serve as an effective substitute for ABP, with the potential to safely maintain long-term esthetics and strength.

PMID:41212954 | DOI:10.1227/ons.0000000000001847