Yutaka Kuroda1, Ryuta Asada2, Kazutaka So3, Atsushi Yonezawa4, Manabu Nankaku5, Kumi Mukai6, Toshiko Ito-Ihara6, Harue Tada7, Michio Yamamoto7, Toshinori Murayama6, Satoshi Morita7, Yasuhiko Tabata8, Masayuki Yokode6, Akira Shimizu9, Shuichi Matsuda3, Haruhiko Akiyama10. 1. Department of Orthopaedic Surgery, Graduate School of Medicine, Kyoto University, Shogoin, Kawahara-cho 54, Sakyo-ku, Kyoto, 606-8507, Japan. ykuromd@kuhp.kyoto-u.ac.jp. 2. Clinical Research Center, Gifu University Hospital, Gifu, Japan. 3. Department of Orthopaedic Surgery, Graduate School of Medicine, Kyoto University, Shogoin, Kawahara-cho 54, Sakyo-ku, Kyoto, 606-8507, Japan. 4. Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital, Kyoto, Japan. 5. Rehabilitation Unit, Kyoto University Hospital, Kyoto, Japan. 6. Department of Clinical Innovative Medicine, Institute for Advancement of Clinical and Translational Research (iACT), Kyoto University Hospital, Kyoto, Japan. 7. Department of Data Science, Institute for Advancement of Clinical and Translational Research (iACT), Kyoto University Hospital, Kyoto, Japan. 8. Department of Biomaterials, Field of Tissue Engineering, Institute for Frontier Medical Sciences, Kyoto University, Kyoto, Japan. 9. Department of Experimental Therapeutics, Institute for Advancement of Clinical and Translational Research (iACT), Kyoto University Hospital, Kyoto, Japan. 10. Department of Orthopaedic Surgery, Gifu University, Gifu, Japan.
Abstract
PURPOSE: We evaluated the safety and clinical outcomes of a single local administration of gelatin hydrogel impregnated with recombinant human fibroblast growth factor (rhFGF)-2 for the treatment of the precollapse stage of osteonecrosis of the femoral head (ONFH). METHODS: Patients with ONFH (precollapse stage ≤2) received a single local administration of 800 μg of rhFGF-2-impregnated gelatin hydrogel and were followed up for one year. The surgery was performed using a minimally invasive technique involving a 1-cm skin incision, and walking was allowed from day one postoperatively. The primary outcomes included occurrence of adverse events and complications. The secondary outcomes included changes in the Harris hip scores, visual analog scale for pain scores, University of California, Los Angeles (UCLA) activity scores, and radiological images. RESULTS: We included ten patients, of which five experienced 14 adverse events, including one complication from spinal anesthesia. However, patients completely recovered from all adverse events. The mean clinical scores significantly improved by one year postoperatively compared with the pre-operative scores (before vs. after: visual analog score for pain, 21.2 vs. 5.3 mm; UCLA activity score, 5.5 vs. 6.6; Harris hip score, 81.0 vs. 96.9 points). There was only one case of femoral head collapse; however, this occurred in a hip with extensive necrosis. Stage progression and collapse did not occur in the other nine cases. Computed tomography confirmed bone regeneration in the femoral heads. CONCLUSIONS: Clinical application of rhFGF-2-impregnated gelatin hydrogel for patients with precollapse ONFH was feasible and safe.
PURPOSE: We evaluated the safety and clinical outcomes of a single local administration of gelatin hydrogel impregnated with recombinant human fibroblast growth factor (rhFGF)-2 for the treatment of the precollapse stage of osteonecrosis of the femoral head (ONFH). METHODS:Patients with ONFH (precollapse stage ≤2) received a single local administration of 800 μg of rhFGF-2-impregnated gelatin hydrogel and were followed up for one year. The surgery was performed using a minimally invasive technique involving a 1-cm skin incision, and walking was allowed from day one postoperatively. The primary outcomes included occurrence of adverse events and complications. The secondary outcomes included changes in the Harris hip scores, visual analog scale for pain scores, University of California, Los Angeles (UCLA) activity scores, and radiological images. RESULTS: We included ten patients, of which five experienced 14 adverse events, including one complication from spinal anesthesia. However, patients completely recovered from all adverse events. The mean clinical scores significantly improved by one year postoperatively compared with the pre-operative scores (before vs. after: visual analog score for pain, 21.2 vs. 5.3 mm; UCLA activity score, 5.5 vs. 6.6; Harris hip score, 81.0 vs. 96.9 points). There was only one case of femoral head collapse; however, this occurred in a hip with extensive necrosis. Stage progression and collapse did not occur in the other nine cases. Computed tomography confirmed bone regeneration in the femoral heads. CONCLUSIONS: Clinical application of rhFGF-2-impregnated gelatin hydrogel for patients with precollapse ONFH was feasible and safe.
Authors: Zheng Li; Chao Jiang; Xingye Li; William K K Wu; Xi Chen; Shibai Zhu; Chanhua Ye; Matthew T V Chan; Wenwei Qian Journal: Cell Prolif Date: 2017-12-04 Impact factor: 6.831
Authors: Miaoyuan Lin; Jibin Yang; Wenqiang Yan; Ning Hu; Ziming Liu; Li Zhang; Yuwan Li Journal: Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi Date: 2021-11-15