Yutaka Kuroda1, Toshiko Ito-Ihara2, Hiroyasu Abe3, Manabu Nankaku4, Yaichiro Okuzu1, Toshiyuki Kawai1, Koji Goto1, Shuichi Matsuda1. 1. Department of Orthopaedic Surgery, Graduate School of Medicine, Kyoto University, Shogoin, Kawahara-cho 54, Sakyo-ku, Kyoto 606-8507, Japan. 2. Department of Clinical Innovative Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan. 3. Department of Biomedical Statistics & Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan. 4. Rehabilitation Unit, Kyoto University Hospital, Kyoto, Japan.
Abstract
Aim: To evaluate the 5-year outcomes from the prospective study of recombinant human FGF-2 (rhFGF-2) for osteonecrosis of the femoral head (ONFH). Methods: Ten patients (average age 39.8 years) with nontraumatic, precollapse ONFH were percutaneously administered with 800 μg rhFGF-2 contained in gelatin hydrogel. Radiological changes and the prevalidated Harris hip score (HHS), visual analogue scale for pain and University of California, Los Angeles activity-rating scale scoring systems were evaluated. Results: The 5-year comparison in type C2 showed higher joint preservation in the rhFGF-2 group (71.4%) than in the natural course group (15.4%). Two of three clinical scores (Harris hip score and visual analogue scale for pain) improved significantly. Postoperative MRI demonstrated significant reduction in ONFH size. There were no adverse events. Conclusion: rhFGF-2 treatment for ONFH appears to be safe and effective and may have the potential to prevent disease progression.
Aim: To evaluate the 5-year outcomes from the prospective study of recombinant human FGF-2 (rhFGF-2) for osteonecrosis of the femoral head (ONFH). Methods: Ten patients (average age 39.8 years) with nontraumatic, precollapse ONFH were percutaneously administered with 800 μg rhFGF-2 contained in gelatin hydrogel. Radiological changes and the prevalidated Harris hip score (HHS), visual analogue scale for pain and University of California, Los Angeles activity-rating scale scoring systems were evaluated. Results: The 5-year comparison in type C2 showed higher joint preservation in the rhFGF-2 group (71.4%) than in the natural course group (15.4%). Two of three clinical scores (Harris hip score and visual analogue scale for pain) improved significantly. Postoperative MRI demonstrated significant reduction in ONFH size. There were no adverse events. Conclusion: rhFGF-2 treatment for ONFH appears to be safe and effective and may have the potential to prevent disease progression.
Entities:
Keywords:
FGF; avascular necrosis; bone regeneration; clinical trial; core decompression; gelatin; growth factor; hydrogel; osteonecrosis of the femoral head