背景:一种生物整合纤维增强植入物(OSSIOfiber®锤趾固定植入物,OSSIO有限公司凯撒利亚,以色列)在先前的研究中,近端指间关节(PIPJ)矫正-关节固定术在1年随访(1FU)时显示出部分生物整合。该研究被延长以评估2年随访(2FU)时的生物整合。
方法:24例使用纤维增强植入物进行近端指间关节(PIPJ)矫正-关节固定术的患者,并在1FU进行分析,完成2FU。随访包括临床检查,患者报告的结果,射线照片,MRI和生物整合评分。结果在1FU和2FU之间进行比较(配对t检验)。
结果:射线照片证实在2FU(1FU,92%(n=22))。21%(n=5)的种植体不再可见,部分可见33%(n=8),在46%(n=11)中完全可见(1FU,完全可见100%(n=24))。植入物和周围骨之间的边界在88%(n=21)中不可见,在12%(n=3)中部分可见(1FU,边界部分可见100%(n=24))。1FU/2FU未见囊肿形成或积液发现。4%(n=1)(1FU,29%(n=7))。没有任何水肿发现被认为是不良植入物相关的。在2FU时,平均生物整合评分为9.71±0.69(1FU,7.71±0.46)。2FU与1FU相比,种植体与骨之间的边界和骨水肿参数进一步改善,2FU时的总生物整合评分也高于1FU(各p<0.05)。
结论:这项研究表明,PIPJ融合率为96%,生物整合从1FU增加到2FU,在2FU达到纤维增强植入物的先进生物集成。
BACKGROUND: A bio-integrative fiber-reinforced implant (OSSIOfiber® Hammertoe Fixation Implant, OSSIO Ltd., Caesarea, Israel) for proximal interphalangeal joint (PIPJ) correction-arthrodesis showed partial bio-integration at 1-year follow-up (1FU) in a previous study. The study was prolonged to assess the bio-integration at 2-year-follow-up (2FU).
METHODS: Twenty-four patients with proximal interphalangeal joint (PIPJ) correction-arthrodesis using the fiber-reinforced implant and analysed at 1FU, completed 2FU. Follow-up included clinical examination, patient reported outcomes, radiographs, MRI and bio-integration scoring. Results were compared between the 1FU and 2FU (paired t-test).
RESULTS: Radiographs confirmed fusion in 96 % (n = 23) at 2FU (1FU, 92 % (n = 22)). Implant was no longer visible in 21 % (n = 5), partially visible in 33 % (n = 8), and fully visible in 46 % (n = 11)(1FU, fully visible 100 % (n = 24)). The border between implant and surrounding bone was scored not visible in 88 % (n = 21) and partially visible in 12 % (n = 3) (1FU, border partially visible 100 % (n = 24)). There were no cyst formation or fluid accumulation findings 1FU/2FU. Mild bone edema was detected in 4 % (n = 1) (1FU, 29 % (n = 7)). None of the edema findings were considered as adverse implant related. The mean bio-integration score was 9.71 ± 0.69 at 2FU (1FU, 7.71 ± 0.46). The parameters of border between implant and bone and bone edema further improved at the 2FU compared to the 1FU, total bio-integration score was also higher at 2FU than 1FU (each p < 0.05).
CONCLUSIONS: This study demonstrates 96 % PIPJ fusion rate and increased bio-integration from 1FU to 2FU, reaching advanced bio-integration of the fiber-reinforced implant at 2FU.