Conference Proceeding

Joint-preserving regenerative therapy using controlled release of rhFGF-2 for patients with osteonecrosis of the femoral head.

Dr. Yutaka Kuroda,
Kyoto University, Japan

Background: For many years, minimally invasive joint-preserving regenerative therapy has been desired for the early stages of osteonecrosis of the femoral head (ONFH). The purpose of this study was to evaluate the safety and clinical outcomes of a single local administration of recombinant human fibroblast factor (rhFGF)-2-impregnated gelatin hydrogel for the precollapse stage of ONFH.
Methods: Ten patients with femoral heads up to precollapse stage 2 underwent a single local administration of 800-µg rhFGF-2-impregnated gelatin hydrogel and were followed up for one year. Primary outcomes included adverse events and complications. Secondary outcomes included changes in Harris Hip Scores, visual analog scale pain scores, UCLA activity rating scores, radiological changes as determined via radiographs, computed tomography scans, and magnetic resonance imaging of the hip joint.
Results: All Adverse events were recovered without problem. The surgery was performed with a minimally invasive technique based core decompression (1 cm of skin incision), and walking was allowed from the day after surgery. Mean clinical scores improved significantly after two year compared with before surgery (before vs. after: VAS for pain, 21.2 vs. 5.3 mm; UCLA activity score 5.5 vs. 6.6; HHS, 81.0 vs. 98.4 points, respectively). There was only one case of femoral head collapse, and it had the greatest necrosis volume fraction and was considered to be in the early collapse stage at the time of operation. The other nine cases did not involve ONFH stage progression, and collapse was prevented. CT images and recent MRI 3 year postoperatively confirmed bone regeneration and reduction of the necrotic area.
Conclusions: Clinical application of rhFGF-2-impregnated gelatin hydrogel for patients with precollapse stage of ONFH was feasible and safe.

Published: 28 April 2017