A pilot study of regenerative therapy using controlled release of recombinant human fibroblast growth factor for patients with pre-collapse osteonecrosis of the femoral head

Yutaka Kuroda, Ryuta Asada, Kazutaka So, Atsushi Yonezawa, Manabu Nankaku, Kumi Mukai, Toshiko Ito-Ihara, Harue Tada, Michio Yamamoto, Toshinori Murayama, Satoshi Morita, Yasuhiko Tabata, Masayuki Yokode, Akira Shimizu, Shuichi Matsuda, Haruhiko Akiyama

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17 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1747-1754
Number of pages8
JournalInternational Orthopaedics
Volume40
Issue number8
DOIs
Publication statusPublished - Aug 1 2016
Externally publishedYes

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Keywords

  • Clinical trial
  • Femoral head
  • FGF
  • Growth factor
  • Osteonecrosis
  • Regenerative therapy

ASJC Scopus subject areas

  • Orthopedics and Sports Medicine

Cite this

Kuroda, Y., Asada, R., So, K., Yonezawa, A., Nankaku, M., Mukai, K., Ito-Ihara, T., Tada, H., Yamamoto, M., Murayama, T., Morita, S., Tabata, Y., Yokode, M., Shimizu, A., Matsuda, S., & Akiyama, H. (2016). A pilot study of regenerative therapy using controlled release of recombinant human fibroblast growth factor for patients with pre-collapse osteonecrosis of the femoral head. International Orthopaedics, 40(8), 1747-1754. https://doi.org/10.1007/s00264-015-3083-1