Local application of recombinant human fibroblast growth factor-2 on bone repair: A dose–escalation prospective trial on patients with osteotomy

✍ Scribed by Hiroshi Kawaguchi; Seiya Jingushi; Toshihiro Izumi; Masao Fukunaga; Takashi Matsushita; Takashi Nakamura; Kosaku Mizuno; Toshitaka Nakamura; Kozo Nakamura

• Publisher: Elsevier Science
• Year: 2007
• Tongue: English
• Weight: 183 KB
• Volume: 25
• Category: Article
• ISSN: 0736-0266
• DOI: 10.1002/jor.20315

✦ Synopsis

Abstract

Based on preclinical evidence in animal models, the present study examined the clinical efficacy and safety of recombinant human fibroblast growth factor‐2 (rhFGF‐2) to accelerate bone repair in a dose‐escalation prospective trial. One of three dosages (200, 400 or 800 µg) of rhFGF‐2 in a biodegradable gelatin hydrogel was injected during surgery into the osteotomy site of 59 knee osteoarthritis patients undergoing high tibial osteotomy, and 57 of them were monitored for 16 weeks. The rhFGF‐2 dose dependently increased the percentage of patients with radiographic bone union, and decreased the average time needed for such union. The percentages of patients with an absence of pain and full‐weight bearing were also greater in the higher dosage groups than in the low dosage group, especially in the clinically critical periods 6, 8, and 10 weeks. Neither blood chemistries nor clinical adverse events were associated with the rhFGF‐2 dosages. We therefore conclude that the rhFGF‐2 in gelatin hydrogel dose dependently accelerated radiographic bone union of a surgical osteotomy with a safety profile at least at the dosages used, suggesting the clinical efficacy of this agent for bone repair. © 2007 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 25:480–487, 2007