Kuroda Yutaka, Asada Ryuta, So Kazutaka, Yonezawa Atsushi, Nankaku Manabu, Mukai Kumi, Ito-Ihara Toshiko, Tada Harue, Yamamoto Michio, Murayama Toshinori, Morita Satoshi, Tabata Yasuhiko, Yokode Masayuki, Shimizu Akira, Matsuda Shuichi, Akiyama Haruhiko
Department of Orthopaedic Surgery, Graduate School of Medicine, Kyoto University, Shogoin, Kawahara-cho 54, Sakyo-ku, Kyoto, 606-8507, Japan.
Clinical Research Center, Gifu University Hospital, Gifu, Japan.
Int Orthop. 2016 Aug;40(8):1747-1754. doi: 10.1007/s00264-015-3083-1. Epub 2015 Dec 29.
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).
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.
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.
Clinical application of rhFGF-2-impregnated gelatin hydrogel for patients with precollapse ONFH was feasible and safe.
我们评估了单次局部应用负载重组人成纤维细胞生长因子（rhFGF）-2的明胶水凝胶治疗股骨头坏死（ONFH）塌陷前期的安全性和临床疗效。
ONFH患者（塌陷前期≤2期）单次局部应用800μg负载rhFGF-2的明胶水凝胶，并随访1年。手术采用微创技术，皮肤切口1cm，术后第1天即可下地行走。主要结局包括不良事件和并发症的发生情况。次要结局包括Harris髋关节评分、视觉模拟疼痛评分、加利福尼亚大学洛杉矶分校（UCLA）活动评分及影像学图像的变化。
我们纳入了10例患者，其中5例发生了14起不良事件，包括1例脊髓麻醉并发症。然而，所有患者均从不良事件中完全康复。与术前评分相比，术后1年时平均临床评分显著改善（术前与术后：视觉模拟疼痛评分，21.2对5.3mm；UCLA活动评分，5.5对6.6；Harris髋关节评分，81.0对96.9分）。仅1例发生股骨头塌陷；然而，该例发生于广泛坏死的髋关节。其他9例未发生分期进展和塌陷。计算机断层扫描证实股骨头有骨再生。
负载rhFGF-2的明胶水凝胶用于塌陷前期ONFH患者的临床应用是可行且安全的。
