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临床试验/NCT06322381
NCT06322381尚未招募不适用

Reinsertion Achilles Tendon VS Zadek Osteotomy in Insertional Achilles Tendinopathy: a Randomized Controlled Trial

Assiut University0 个研究点目标入组 42 人开始时间: 2025年2月16日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
42
主要终点
the time needed to return to normal daily activities (functional outcome) assessed by foot and ankle outcome score.

研究概览

简要总结

The aim of this study is to Compare functional outcome and the recovery time of reinsertion of achilles tendon VS zadek osteotomy in insertional achilles tendinopathy.

详细描述

Insertional Achilles tendinopathy is characterized by chronic posterior heel pain associated with posterosuperior calcaneal exostosis or intratendinous ossification. The etiologies include retrocalcaneal exostosis, the diseased tendon, enthesopathy, and Haglund's deformity. The nonsurgical therapies, such as physical therapy, stretching and strengthening of the gastrocnemius-soleus muscle complexes, nonsteroid anti-inflammatory drugs, and footwear modifications, are chosen as the initial treatment. Local injection of the steroid is not recommended because it might lead to increase risk of tendon rupture.

Surgical intervention is a suitable option when conservative treatment for more than 6 months has failed. Open detachment with reattachment of the Achilles tendon is a common surgery combined with calcaneoplasty and debridement of the retrocalcaneal bursitis and pathologic Achilles tendon. Suture techniques using bone anchors have been described to reattach the Achilles tendon with excellent results. percutaneous Osteotomy is another option, first described by Zadek in 1939 which was later modified in 1965. zadek osteotomy is a dorsal closing wedge calcaneal osteotomy that allows the tuberosity of Haglund deformity to be brought forward. This operation can change the calcaneus' anatomical length and elevate the distal insertion point of the AT. The rationale of a ZO was to reduce the impingement between the anterior aspect of the Achilles tendon and the superior angle of the posterior calcaneal tuberosity. By shortening the calcaneus and altering the orientation of the Achilles tendon fibers it is believed to decrease stress across the tendon at its insertion.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age range 18 - 65
  • Insertional Achilles tendinopathy without steroid injection, infection, tendon rupture and ankle fracture

排除标准

  • Age < 18 years, > 65
  • General medical contraindications to surgical interventions
  • Calcaneal Fracture, subtalar fusion
  • infection.
  • Pathological tendon rupture
  • History of steroid injection

结局指标

主要结局

the time needed to return to normal daily activities (functional outcome) assessed by foot and ankle outcome score.

时间窗: up to1 year post baseline

foot and ankle outcome score is a tool to measure the symptoms, stiffness, pain, function, daily living, sports and recreational activities of foot and ankle problems. It is based on 100 questions and ranges from 0 to 100, with higher scores indicating more severe symptoms or limitations.

次要结局

  • Rate of complications(up to1 year post baseline)
  • Pain assessed by the visual analogue scale.(up to1 year post baseline)

研究者

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

Abanoub Henen Helmy Samaan

Resident in Orthopedic department at Assiut university

Assiut University

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