Faculty of Medicine, Université Libre de Bruxelles, Brussels, Belgium.
Boston Children's Hospital, Department of Orthopaedic Surgery, Harvard Medical School, Boston, Massachusetts, USA.
Bone Joint J. 2024 Aug 1;106-B(8):871-878. doi: 10.1302/0301-620X.106B8.BJJ-2024-0094.R1.
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.
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.
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.
The needle tenotomy is noninferior to the blade tenotomy for usage in Ponseti treatment for idiopathic clubfoot in children aged below 36 months.
在 Ponseti 治疗特发性马蹄内翻足期间，经皮跟腱切断术的金标准是使用 15 号刀片进行切断。本试验旨在确定使用大口径针进行切断的技术不劣于金标准。
我们将年龄在 36 个月以下的特发性马蹄内翻足患儿的足部按 1:1 的比例随机分为刀片组或针组。术后 3 周和 3 个月时进行随访，记录背屈范围、Pirani 评分和并发症。非劣效性边界设定为术后 3 个月背屈范围相差 4°。
刀片组在两次随访时的背屈范围均较大：术后 3 周时为 18.36°对 18.03°（p = 0.115），术后 3 个月时为 18.96°对 18.26°（p = 0.001）。3 个月时的平均差值为 0.7°，远低于非劣效性边界的 4°。Pirani 评分无显著差异。术后 3 个月时，刀片组的疤痕标记比针组更广泛（8 例对 2 例）。未记录到主要并发症。
在 36 个月以下的儿童中，使用 Ponseti 治疗特发性马蹄内翻足时，针式跟腱切断术与刀片式切断术不劣于刀片式切断术。
