Clinical Trial for the Safety and Feasibility of Pedicle Screws Coated with a Fibroblast Growth Factor-2-Apatite Composite Layer for Posterior Cervical Fusion Surgery

Overview

Journal J Clin Med

Specialty General Medicine

Date 2023 Feb 11

PMID 36769595

Authors

Katsuya Nagashima

Yuki Hara

Hirotaka Mutsuzaki

Yasukazu Totoki

Eriko Okano

Kentaro Mataki

Yukei Matsumoto

Yohei Yanagisawa

Hiroshi Noguchi

Yu Sogo

Atsuo Ito

Masao Koda

Masashi Yamazaki

Affiliations

Soon will be listed here.

Abstract

To solve the instrument loosening problem, we developed a fibroblast growth factor-2-calcium phosphate composite layer as a novel coating material to improve screw fixation strength. The primary aim of the present study was to demonstrate the safety and feasibility of screws coated with the FGF-2-calcium phosphate composite layer for posterior instrumented surgery of the cervical spine. The trial design was a single-arm, open-label, safety and feasibility study. Patients receiving fusion of the cervical spine from C2 (or C3) to C7 (or T1) were recruited. The primary endpoint to confirm safety was any screw-related adverse events. Seven patients who underwent posterior fusion surgery of the cervical spine were enrolled in the present study. The coated pedicle screws were inserted bilaterally into the lowest instrumented vertebrae. There was only one severe adverse event unrelated with the coated screw. Three out of the fourteen coated screws showed loosening. The present results prove the safety and feasibility of pedicle screws coated with the FGF-2-calcium phosphate composite layer for fusion surgery in the cervical spine. This is the first step to apply this novel surface coating in the field of spine surgery.

Citing Articles

Safety and Osteointegration of Titanium Screws Coated with a Fibroblast Growth Factor-2-Calcium Phosphate Composite Layer in Non-Human Primates: A Pilot Study.

Matsumoto Y, Mutsuzaki H, Hara Y, Nagashima K, Okano E, Yanagisawa Y J Funct Biomater. 2023; 14(5).

PMID: 37233371 PMC: 10219525. DOI: 10.3390/jfb14050261.

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