一项单中心、单盲、随机、平行分组、非劣效性试验，旨在比较 22 号针头与 15 号刀片在 244 例马蹄内翻足中进行跟腱切断术的疗效 - 研究方案。
A single-center, single-blinded, randomized, parallel-group, non-inferiority trial to compare the efficacy of a 22-gauge needle versus a 15 blade to perform an Achilles tendon tenotomy in 244 clubfeet-study protocol.
机构信息
Faculty of Medicine, Université Libre de Bruxelles, Brussels, Belgium.
Department of Pediatric Orthopedics, Hôpital Necker - Enfants Malades, Paris Cité University, Paris, France.
出版信息
Trials. 2023 Oct 31;24(1):701. doi: 10.1186/s13063-023-07728-9.
BACKGROUND
Achilles tendon tenotomy is an integral part of the Ponseti method, aimed at correcting residual equinus and lack of dorsiflexion after correction of the adductus deformity in clubfoot. Percutaneous tenotomy using a number 15 scalpel blade is considered the gold standard, resulting in excellent results with minimal complications. The use of a large-bore needle to perform Achilles tendon tenotomies has been described in literature, but a large-scale randomized controlled trial is currently lacking. In this trial, we aim to show the non-inferiority of the needle tenotomy technique compared to the gold standard blade tenotomy technique.
METHODS
We will randomize 244 feet into group A: needle tenotomy or group B: blade tenotomy. Randomization will be done using a block randomization with random block sizes and applying a 1:1 allocation to achieve an intervention and control group of the exact same size. Children will be evaluated at 3 weeks and 3 months post-tenotomy for primary and secondary clinical outcomes. The primary clinical outcome will be the range of dorsiflexion obtained the secondary clinical outcomes will be frequency of minor and major complications and Pirani score. The non-inferiority margin was set at 4°, and thus, the null hypothesis of inferiority of the needle technique will be rejected if the mean difference between both techniques is less than 4°. The statistical analysis will use a multi-level mixed effects linear regression model for the primary outcomes and a multi-level mixed effects logistic regression model for the secondary clinical outcomes. The physician performing the evaluations post-tenotomy will be the only one blinded to group allocation.
TRIAL REGISTRATION
This trial was registered prospectively with ClinicalTrials.gov registration number: NCT04897100 on 21 May 2021.
背景
跟腱切断术是潘塞蒂方法的一个组成部分，旨在纠正马蹄内翻足畸形矫正后残余的马蹄和背屈不足。使用 15 号手术刀进行经皮切断术被认为是金标准，可获得极佳的效果，且并发症极少。文献中描述了使用大口径针进行跟腱切断术，但目前缺乏大规模的随机对照试验。在这项试验中，我们旨在证明与金标准刀片切断术相比，针切断术技术的非劣效性。
方法
我们将随机将 244 只脚分为 A 组：针切断术或 B 组：刀片切断术。随机化将采用块随机化，随机块大小，并采用 1:1 分配以实现干预组和对照组的完全相同大小。儿童将在切断后 3 周和 3 个月时进行主要和次要临床结果评估。主要临床结果将是获得的背屈范围，次要临床结果将是轻微和主要并发症的频率和皮拉尼评分。非劣效性边界设定为 4°，如果两种技术之间的平均差异小于 4°，则将拒绝针技术劣于刀片技术的无效假设。统计分析将使用多级混合效应线性回归模型进行主要结果分析，以及多级混合效应逻辑回归模型进行次要临床结果分析。进行切断后评估的医生将是唯一对分组分配不知情的人。
试验注册
该试验前瞻性地在 ClinicalTrials.gov 注册，注册号为 NCT04897100，于 2021 年 5 月 21 日注册。
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