1. Recombinant human FGF-2 for the treatment of early-stage osteonecrosis of the femoral head: TRION, a single-arm, multicenter, Phase II trial
- Author
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Yutaka Kuroda, Takeyuki Tanaka, Takaki Miyagawa, Hidetoshi Hamada, Hiroyasu Abe, Toshiko Ito-Ihara, Ryuta Asada, Yusuke Fujimoto, Daisuke Takahashi, Tomonori Tetsunaga, Ayumi Kaneuji, Michiaki Takagi, Yutaka Inaba, Satoshi Morita, Nobuhiko Sugano, Sakae Tanaka, Shuichi Matsuda, Haruhiko Akiyama, Tsuyoshi Asano, Juji Ito, Hirofumi Oshima, Taizo Kaneko, Yoko Fukasawa, Hyonmin Choe, Shusuke Ueda, Kayoko Enomoto, Harue Tada, Akiko Kuroda, Yasuhiko Tabata, Yaichiro Okuzu, Toshiyuki Kawai, Koji Goto, Manabu Nankaku, Masaki Takao, Wataru Ando, Kazuki Yamada, Michio Yamamoto, Takashi Sakai, Yasuhiro Ishidou, Shigeru Yamada, Hidetsugu Ohara, Hiroshi Fujita, Hirotsugu Ohashi, Hirokazu Iida, and Takashi Nakamura
- Subjects
gelatin hydrogel ,Embryology ,medicine.medical_specialty ,Arthroplasty, Replacement, Hip ,Biomedical Engineering ,Avascular necrosis ,03 medical and health sciences ,Femoral head ,0302 clinical medicine ,bone regeneration ,Femur Head Necrosis ,medicine ,FGF ,Humans ,030212 general & internal medicine ,Clinical efficacy ,Stage (cooking) ,Adverse effect ,Bone regeneration ,avascular necrosis ,030222 orthopedics ,business.industry ,core decompression ,clinical trial ,growth factor ,Femur Head ,osteonecrosis of femoral head ,medicine.disease ,Phase II ,Surgery ,Clinical trial ,regenerative therapy ,Treatment Outcome ,medicine.anatomical_structure ,Radiological weapon ,Fibroblast Growth Factor 2 ,business - 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.
- Published
- 2021
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