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临床试验/NCT04897100
NCT04897100已完成不适用

Outcome and Complications After Percutaneous Needle Versus Blade Achilles Tenotomy in Clubfoot Treated With the Ponseti Method

Indus Hospital and Health Network1 个研究点 分布在 1 个国家目标入组 244 人开始时间: 2020年3月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
244
试验地点
1
主要终点
Dorsiflexion

研究概览

简要总结

Achilles tendon tenotomy is an integral part of the Ponseti method, aimed at correcting residual equinus after correction of the adductus deformity. Tenotomy rates ranging from 63-95% after full cycle of castings have been reported in literature. Percutaneous tenotomy is the gold standard, which can usually be performed in an out-patient setting under local anesthesia using a scalpel blade. A complication rate of 2% (mainly neurovascular injury)has been reported in literature, with accidental sectioning of the peroneal artery being the most common. Development of a pseudo-aneurysm after accidental sectioning of the peroneal artery has been reported in a case report; this delayed further clubfoot treatment.

Percutaneous needle tenotomy has been described by some authors as an alternative technique with very favorable results in a population before walking age. This technique use a large-gauge (16-19 G) needle to percutaneously cut the Achilles tendon. Although bleeding has been reported following this technique with similar rates as for the percutaneous blade technique, no major complications have been reported as yet using the needle technique.

We would like to compare the clinical outcomes and complication rates of both techniques, supporting our hypothesis that both techniques are equally safe and have the same success rate.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
— 至 36 Months(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Idiopathic clubfoot.
  • •Age less than or equal to 36 months at the time of tenotomy.
  • •Enrolled at the Pehla Qadam clinic at The Indus Hospital in Karachi.
  • •Fully corrected Adductus deformity with residual equinus after a full casting cycle.
  • •Completing routine follow up for 3 months post tenotomy.

排除标准

  • •Refusal of parents to enroll child into this study.
  • •Syndromic clubfoot.
  • •Previous treatment for clubfoot (surgical or non-surgical) received.
  • •Underlying medical conditions unrelated to clubfoot that may serve as a contra-indication, this decision will be left on the discretion of the treating orthopedic surgeon

研究组 & 干预措施

Needle tenotomy

Experimental

Patient will receive an Achilles tendon tenotomy using a 22G needle when randomized into the needle group. Follow-up to measure dorsiflexion and register complications will be assured at 3 weeks and 3 months.

干预措施: Achilles tendon tenotomy (Procedure)

Blade tenotomy

Active Comparator

Patient will receive an Achilles tendon tenotomy using a 11 blade when randomized into the needle group. Follow-up to measure dorsiflexion and register complications will be assured at 3 weeks and 3 months.

干预措施: Achilles tendon tenotomy (Procedure)

结局指标

主要结局

Dorsiflexion

时间窗: 3 months

Ankle dorsiflexion measured in degrees

次要结局

  • Complications(3 months)

研究者

发起方
Indus Hospital and Health Network
申办方类型
Other
责任方
Sponsor

研究点 (1)

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