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临床试验/NCT07466043
NCT07466043尚未招募不适用

Midfoot Osteotomy Versus 8-Plate Epiphysiodesis for Residual Metatarsal Adductus in Relapsed Congenital Talipes Equinovarus

Assiut University0 个研究点目标入组 40 人开始时间: 2026年2月18日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
主要终点
To compare the results of the two technical procedures of surgical treatment by Radiological correction

研究概览

简要总结

Epiphysiodesis

详细描述

Congenital Talipes Equinovarus (CTEV) is a significant musculoskeletal deformity affecting children globally. It is characterized by hindfoot varus, midfoot cavus, forefoot adduction, and ankle equines (1). The Ponseti method has proven to be highly effective and is now the gold standard for treatment. However, long-term follow-up studies indicate a variable relapse rate. Timely diagnosis of relapse is crucial, underscoring the importance of regular follow-up visits (2).

Nowadays the method has replaced the surgery and served as the gold standard for the treatment of congenital clubfoot in pediatric orthopedics(3) . However, it is still challenging to treat severe cases such as neglected or relapsed clubfoot in older children(4). Among the deformities, residual forefoot adduction with supination after treatment is a common issue which is also referred to as the "bean-shaped foot"( 5) . According to Jasiewicz et.al study, the combination of a cuboid closing with a cuneiform opening wedge osteotomy or with a trans-midfoot osteotomy is currently the most popular procedure to correct the residual forefoot adduction(6).

However, complications such as neurovascular lesion, non-union or permanent foot stiffness might occur as a result of the operation. In addition, the tarsal growth plate and cartilaginous area could be compromised due to the difficulty in manipulating the osteotomy and fixation process(7). 8-plate is one of the major methods that gained popularity quickly due to temporary growth impediment of the physis without damaging it irreversibly, and is suitable for a variety of indications including different plane deformities around the knee and limb length discrepancies(8). However, there are a few reports regarding 8-plates in individuals with clubfoot deformities. Recently, guided growth techniques using temporary epiphysiodesis (8 -plate) have been introduced as a minimally invasive alternative that allows gradual correction by modulating growth.However, high-quality comparative clinical evidence between these two techniques is lacking.

The current research is the first one to compare the clinical, radiological, and patient satisfaction outcome of midfoot osteotomy versus eight -Plate epiphysiodesis for residual metatarsal adductus in relapsed clubfoot.The purpose of this prospective study is to show the best technique to achieve patient satisfaction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
4 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients are eligible for participation in the study if
  • Age between 5 to 10 years old
  • Relapsed idiopathic clubfoot (CTEV)
  • Presence of residual metatarsal adductus

排除标准

  • Patients are excluded for participation in the study if
  • Teratologic clubfoot (e.g., myelomeningocele).
  • Children under 4 years of mild severity that could be corrected with conservative treatment, or above 10 years old.
  • flexible (correctable) deformity of the foot.
  • Cases recurrent after midtarsal osteotomy
  • Neuromuscular CTEV, or arthrogryposis

研究组 & 干预措施

Midfoot Osteotomy

Active Comparator

A closing wedge osteotomy of the cuboid will be performed using an oscillating saw, with the wedge size determined according to the severity of forefoot adduction.

干预措施: Midfoot Osteotomy (Procedure)

8-Plate Epiphysiodesis

Active Comparator

A guidewire will be inserted to confirm proper positioning. A tension-band eight-plate was will then be placed bridging the lateral side of the calcaneocuboid region, with two cannulated 3.5 mm screws inserted-one into the cuboid and one into the calcaneus-ensuring central placement within the cuboid to modulate lateral column growth.

干预措施: 8-Plate Epiphysiodesis (Procedure)

结局指标

主要结局

To compare the results of the two technical procedures of surgical treatment by Radiological correction

时间窗: 6 months after surgery

radiological correction assessed using the Demiglio score to evaluate the outcome of the two surgical techniques.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmoud Ali Hassan Abdelhamid

specialist of orthopedic surgery

Assiut University

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