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

Kuroda, Yutaka, Tanaka, Takeyuki, Miyagawa, Takaki, Hamada, Hidetoshi, Abe, Hiroyasu, Ito-Ihara, Toshiko, Asada, Ryuta, Fujimoto, Yusuke, Takahashi, Daisuke, Tetsunaga, Tomonori, Kaneuji, Ayumi, Takagi, Michiaki, Inaba, Yutaka, Morita, Satoshi, Sugano, Nobuhiko, Tanaka, Sakae, Matsuda, Shuichi, Akiyama, Haruhiko

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, precollapseand 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 regenerationand 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.

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

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