Recombinant human FGF-2 for the treatment of early-stage osteonecrosis of the femoral head: TRION, a single-arm, multicenter, Phase II trial

TRION trial collaborators

Research output: Contribution to journalArticlepeer-review

Abstract

Aim: This study aimed to evaluate the 2-year outcomes from a clinical trial of recombinant human FGF-2 (rhFGF-2) for osteonecrosis of the femoral head (ONFH). Patients & methods: Sixty-four patients with nontraumatic, precollapse and large ONFHs were percutaneously administered with 800 μg rhFGF-2 contained in gelatin hydrogel. Setting the end point of radiological collapse, we analyzed the joint preservation period of the historical control. Changes in two validated clinical scores, bone regeneration and safety were evaluated. Results: Radiological joint preservation time was significantly higher in the rhFGF-2 group than in the control group. The ONFHs tended to improve to smaller ONFHs. The postoperative clinical scores significantly improved. Thirteen serious adverse events showed recovery. Conclusion: rhFGF-2 treatment increases joint preservation time with clinical efficacy, radiological bone regeneration and safety.

Original languageEnglish
Pages (from-to)535-548
Number of pages14
JournalRegenerative Medicine
Volume16
Issue number6
DOIs
Publication statusPublished - Jun 2021

Keywords

  • avascular necrosis
  • bone regeneration
  • clinical trial
  • core decompression
  • FGF
  • gelatin hydrogel
  • growth factor
  • osteonecrosis of femoral head
  • Phase II
  • regenerative therapy

ASJC Scopus subject areas

  • Biomedical Engineering
  • Embryology

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