Department of Otolaryngology, Hôpital Fondation Adolphe de Rothschild, 29 Rue Manin, 75019, Paris, France.
Clinical Research Unit, Hôpital Fondation Adolphe de Rothschild, 29 Rue Manin, 75019, Paris, France.
J Otolaryngol Head Neck Surg. 2023 Aug 11;52(1):52. doi: 10.1186/s40463-023-00654-5.
Stapes prosthesis dislocation is the first cause of revision stapes surgery. To our knowledge, there is no data about stability of the incus attachment of manual crimped prosthesis of different materials. This study aimed to compare the dislocation incidence between titanium and fluoroplastic stapes prostheses.
A monocentric retrospective cohort study was conducted between January 2013 and June 2022 in a tertiary-care center. All patients that underwent a primary stapes surgery with manually crimped fluoroplastic or titanium prostheses were included. Prosthesis dislocation from the incus was identified intraoperatively or with CT scan. The incidence of stapedial prosthesis dislocation over time was estimated using the Kalbfleisch and Prentice survival analysis method. Other indications for revision surgery prior to prosthesis dislocation were considered as competing events. Differences in the cumulative incidence functions between the fluoroplastic group and the titanium group was assessed using the Gray's test.
Eight hundred and fifty-five patients underwent primary stapes surgery during the study period. Fluoroplastic prosthesis was used in 758 (88.7%) cases and titanium prosthesis in 97 (11.3%) cases. Median follow-up was 51.7 months (28.4-80.1). Dislocation was observed in 23 (3.0%) patients with fluoroplastic prosthesis and none (0.0%) in the titanium group. The probability of prosthesis dislocation at two years after surgery was 3.5% in the Teflon group and 0.0% in the Titanium group. No significant difference was found in the cumulative incidence of prosthesis dislocation between the fluoroplastic group and the titanium group (p = 0.12).
Despite lack of statistical power, our results suggest a trend in a more stable incus attachment of manually crimped titanium stapes prosthesis compared to fluoroplastic over time. Further prospective randomized studies could be valuable to assess our findings.
镫骨假体脱位是翻修镫骨手术的首要原因。据我们所知，目前尚无关于不同材料手动卷曲假体的砧骨附着稳定性的数据。本研究旨在比较钛和氟塑料镫骨假体脱位的发生率。
这是一项在 2013 年 1 月至 2022 年 6 月期间在一家三级保健中心进行的单中心回顾性队列研究。所有接受手动卷曲氟塑料或钛假体初次镫骨手术的患者均纳入本研究。术中或 CT 扫描发现镫骨假体从砧骨上脱位。使用 Kalbfleisch 和 Prentice 生存分析方法估计随时间推移镫骨假体脱位的发生率。在假体脱位之前，因其他适应证而行翻修手术被视为竞争事件。使用 Gray 检验评估氟塑料组和钛组累积发生率函数之间的差异。
在研究期间，855 例患者接受了初次镫骨手术。758 例（88.7%）使用氟塑料假体，97 例（11.3%）使用钛假体。中位随访时间为 51.7 个月（28.4-80.1）。氟塑料假体组有 23 例（3.0%）患者出现假体脱位，而钛假体组无患者出现脱位。术后两年时，Teflon 组假体脱位的概率为 3.5%，钛组为 0.0%。氟塑料组和钛组之间的假体脱位累积发生率无显著差异（p=0.12）。
尽管缺乏统计学效力，但我们的结果表明，与氟塑料相比，手动卷曲钛镫骨假体的砧骨附着随时间推移更稳定。进一步的前瞻性随机研究可能有助于评估我们的发现。
