Abstract
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 800μg of rhFGF-2-impregnated gelatin hydrogel and were followed up for oneyear. 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 oneyear postoperatively compared with the pre-operative scores (before vs. after: visual analog score for pain, 21.2 vs. 5.3mm; 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.
Highlights
ResultsOf which five experienced 14 adverse events, including one complication from spinal anesthesia
Osteonecrosis of the femoral head (ONFH) is a multifactorial disease that can cause femoral head collapse, pain, gait disorders, and secondary hip osteoarthritis
In an animal study using adult rabbits, we reported that a single local administration of gelatin hydrogel impregnated with recombinant human fibroblast growth factor-2 promoted the regeneration of the necrotic bone and suppressed the progression of osteonecrosis of the femoral head (ONFH) [9]
Summary
We included five men (five hips) and five women (five hips), with a mean age of 39.8 years (range: 29–53 years) at the time of surgery (Table 1). Eight patients had bilateral ONFH, three had already undergone THA on the contralateral side (cases 1, 2, and 8). At the first medical examination, two patients with bilateral disease (cases 4 and 10) had already been scheduled for THA on the contralateral side. A A typical screenshot of pre-operative planning is shown. The surgeon planned the route and drilling position (blue screw). B Preparation of the recombinant human fibroblast growth factor (rhFGF)-2-impregnated gelatin hydrogel. The gelatin hydrogel was bottled with a mandatory 30 minute impregnation time for the rhFGF-2 solution. C Representative pieces of the rhFGF-2impregnated gelatin hydrogel. D A representative intra-operative fluoroscopic image after drilling. E A representative intra-operative photograph showing administration of the gelatin hydrogel using a percutaneous technique The gelatin hydrogel was bottled with a mandatory 30 minute impregnation time for the rhFGF-2 solution. c Representative pieces of the rhFGF-2impregnated gelatin hydrogel. d A representative intra-operative fluoroscopic image after drilling. e A representative intra-operative photograph showing administration of the gelatin hydrogel using a percutaneous technique
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
