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.

中文翻译：

---

用于近端指间关节融合术的纤维增强固定植入物在 2 年随访时显示出先进的植入物生物整合

背景

用于近端指间关节 (PIPJ) 矫正关节固定术的生物整合纤维增强植入物（OSSIOfiber® Hammertoe Fixation Implant，OSSIO Ltd.，Caesarea，Israel）在 1 年随访（1FU）中显示部分生物整合以前的研究。该研究被延长以评估 2 年随访 (2FU) 时的生物整合。

方法

24 名使用纤维增强植入物进行近端指间关节 (PIPJ) 矫正关节固定术并在 1FU 进行分析的患者完成了 2FU。随访包括临床检查、患者报告的结果、放射照片、MRI 和生物整合评分。结果在 1FU 和 2FU（配对 t 检验）之间进行了比较。

结果

射线照片证实 96% (n = 23) 在 2FU 融合（1FU，92% (n = 22)）。植入物在 21% (n = 5) 中不再可见，在 33% (n = 8) 中部分可见，在 46% (n = 11) 中完全可见（1FU，完全可见 100% (n = 24)）。种植体和周围骨骼之间的边界在 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 未发现囊肿形成或液体积聚。在 4% (n = 1) (1FU, 29% (n = 7)) 中检测到轻度骨水肿。水肿发现均未被视为与植入物不良相关。2FU 的平均生物整合评分为 9.71 ± 0.69（1FU，7.71 ± 0.46）。与 1FU 相比，2FU 的种植体与骨之间的边界参数和骨水肿进一步改善，

结论

该研究表明 96% 的 PIPJ 融合率和从 1FU 到 2FU 的生物整合增加，在 2FU 达到纤维增强植入物的高级生物整合。