PDF(Pubmed)
Abstract：
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.
BACKGROUND: This trial was registered prospectively with ClinicalTrials.gov registration number: NCT04897100 on 21 May 2021.
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.
BACKGROUND: This trial was registered prospectively with ClinicalTrials.gov registration number: NCT04897100 on 21 May 2021.
摘要：
背景：跟腱腱切开术是Ponseti方法的组成部分，旨在纠正马蹄内翻足内收畸形后的残余马蹄和背屈不足。使用15号手术刀刀片的经皮肌腱切开术被认为是黄金标准，以最小的并发症产生优异的结果。在文献中已经描述了使用大口径针进行跟腱肌腱切开术，但目前缺乏大规模的随机对照试验.在这次审判中,我们的目的是显示与金标准刀片肌张力切开术相比，针状肌张力切开术技术的非劣效性。
方法：我们将244英尺随机分为A组：针腱切开术或B组：刀片腱切开术。随机化将使用具有随机块大小的块随机化并应用1:1分配以实现完全相同大小的干预和对照组来完成。将在肌腱切开术后3周和3个月评估儿童的主要和次要临床结果。主要临床结果将是获得的背屈范围，次要临床结果将是次要和主要并发症的频率和皮拉尼评分。非劣效性边缘设置为4°，因此，如果两种技术之间的平均差小于4°，则将拒绝针技术的自卑假设。统计分析将对主要结果使用多级混合效应线性回归模型，对次要临床结果使用多级混合效应逻辑回归模型。进行肌腱切开术后评估的医生将是唯一不了解组分配的医生。
背景：该试验于2021年5月21日在ClinicalTrials.gov注册号：NCT04897100进行了前瞻性注册。
方法：我们将244英尺随机分为A组：针腱切开术或B组：刀片腱切开术。随机化将使用具有随机块大小的块随机化并应用1:1分配以实现完全相同大小的干预和对照组来完成。将在肌腱切开术后3周和3个月评估儿童的主要和次要临床结果。主要临床结果将是获得的背屈范围，次要临床结果将是次要和主要并发症的频率和皮拉尼评分。非劣效性边缘设置为4°，因此，如果两种技术之间的平均差小于4°，则将拒绝针技术的自卑假设。统计分析将对主要结果使用多级混合效应线性回归模型，对次要临床结果使用多级混合效应逻辑回归模型。进行肌腱切开术后评估的医生将是唯一不了解组分配的医生。
背景：该试验于2021年5月21日在ClinicalTrials.gov注册号：NCT04897100进行了前瞻性注册。
