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.
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.
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作者：
跟腱切断术是Ponseti方法的一个组成部分，旨在矫正马蹄内翻足内收畸形后的残留马蹄足和背屈不足。使用15号手术刀片的经皮肌腱切开术被认为是金标准，结果良好，并发症最少。文献中已经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。在本试验中，我们旨在证明针式肌腱切断术技术与金标准刀片式肌腱切断术技术相比的非劣效性。我们将244只足随机分为A组：针式肌腱切断术或B组：刀片式肌腱切断术。将使用随机区组大小的区组随机化进行随机化，并应用1：1分配，以获得完全相同大小的干预组和对照组。将在肌腱切开术后3周和3个月对儿童进行主要和次要临床结局评价。主要临床结局将是获得的背屈范围，次要临床结局将是轻微和严重并发症的频率以及Pirani评分。非劣效性界值设定为4°，因此，如果两种技术之间的平均差异小于4°，则拒绝缝针技术劣效性的零假设。统计分析将使用多水平混合效应线性回归模型分析主要结局，使用多水平混合效应logistic回归模型分析次要临床结局。肌腱切开术后进行评价的医生将是唯一对组分配设盲的医生。本试验于2021年5月21日前瞻性注册，注册号为ClinicalTrials.gov：NCT 04897100。在线版本包含补充材料，可通过10.1186/s13063-023-07728-9获得。
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. 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. This trial was registered prospectively with ClinicalTrials.gov registration number: NCT04897100 on 21 May 2021. The online version contains supplementary material available at 10.1186/s13063-023-07728-9.
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影响因子：
3.7
作者：
Doig, GS;Simpson, F
通讯作者：
Simpson, F
影响因子：
15.1
作者：
通讯作者：
--
影响因子：
1.7
作者：
Scher, DM;Feldman, DS;Lehman, WB
通讯作者：
Lehman, WB
DOI：
10.1016/j.foot.2022.101922
发表时间：
2022-09-01
期刊：
Foot (Edinburgh, Scotland)
影响因子：
--
作者：
Rangasamy, Karthick;Baburaj, Vishnu;Sudesh, Pebam
通讯作者：
Sudesh, Pebam
影响因子：
2.7
作者：
Shabtai, Lior;Hemo, Yoram;Segev, Eitan
通讯作者：
Segev, Eitan