Abstract：
UNASSIGNED: The gold standard for percutaneous Achilles tendon tenotomy during the Ponseti treatment for idiopathic clubfoot is a tenotomy with a No. 15 blade. This trial aims to establish the technique where the tenotomy is performed with a large-bore needle as noninferior to the gold standard.
UNASSIGNED: We randomized feet from children aged below 36 months with idiopathic clubfoot on a 1:1 basis in either the blade or needle group. Follow-up was conducted at three weeks and three months postoperatively, where dorsiflexion range, Pirani scores, and complications were recorded. The noninferiority margin was set at 4° difference in dorsiflexion range at three months postoperatively.
UNASSIGNED: The blade group had more dorsiflexion at both follow-up consultations: 18.36° versus 18.03° (p = 0.115) at three weeks and 18.96° versus 18.26° (p = 0.001) at three months. The difference of the mean at three months 0.7° is well below the noninferiority margin of 4°. There was no significant difference in Pirani scores. The blade group had more extensive scar marks at three months than the needle group (8 vs 2). No major complications were recorded.
UNASSIGNED: The needle tenotomy is noninferior to the blade tenotomy for usage in Ponseti treatment for idiopathic clubfoot in children aged below 36 months.
UNASSIGNED: We randomized feet from children aged below 36 months with idiopathic clubfoot on a 1:1 basis in either the blade or needle group. Follow-up was conducted at three weeks and three months postoperatively, where dorsiflexion range, Pirani scores, and complications were recorded. The noninferiority margin was set at 4° difference in dorsiflexion range at three months postoperatively.
UNASSIGNED: The blade group had more dorsiflexion at both follow-up consultations: 18.36° versus 18.03° (p = 0.115) at three weeks and 18.96° versus 18.26° (p = 0.001) at three months. The difference of the mean at three months 0.7° is well below the noninferiority margin of 4°. There was no significant difference in Pirani scores. The blade group had more extensive scar marks at three months than the needle group (8 vs 2). No major complications were recorded.
UNASSIGNED: The needle tenotomy is noninferior to the blade tenotomy for usage in Ponseti treatment for idiopathic clubfoot in children aged below 36 months.
摘要：
■在Ponseti治疗特发性马蹄内翻足的过程中，经皮跟腱腱切开术的金标准是15刀片。该试验旨在建立用大口径针头进行肌腱切开术的技术，该技术不劣于黄金标准。
■我们从36个月以下患有特发性马蹄内翻足的儿童中，以1：1的比例将足部随机分为刀片组或针组。术后3周和3个月进行随访,其中背屈范围，皮拉尼得分,并记录并发症。术后3个月，非劣性切缘的背屈范围相差4°。
■在两次随访咨询中，刀片组的背屈更多：三周时18.36°对18.03°（p=0.115），三个月时18.96°对18.26°（p=0.001）。三个月时的平均值差异为0.7°，远低于4°的非劣效性界限。Pirani评分无显著差异。刀片组在三个月时的疤痕比针组更广泛（8vs2）。无重大并发症记录。
■在36个月以下儿童特发性马蹄内翻足的Ponseti治疗中，针状肌腱切开术不劣于刀状肌腱切开术。
■我们从36个月以下患有特发性马蹄内翻足的儿童中，以1：1的比例将足部随机分为刀片组或针组。术后3周和3个月进行随访,其中背屈范围，皮拉尼得分,并记录并发症。术后3个月，非劣性切缘的背屈范围相差4°。
■在两次随访咨询中，刀片组的背屈更多：三周时18.36°对18.03°（p=0.115），三个月时18.96°对18.26°（p=0.001）。三个月时的平均值差异为0.7°，远低于4°的非劣效性界限。Pirani评分无显著差异。刀片组在三个月时的疤痕比针组更广泛（8vs2）。无重大并发症记录。
■在36个月以下儿童特发性马蹄内翻足的Ponseti治疗中，针状肌腱切开术不劣于刀状肌腱切开术。
