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临床试验/NCT06252389
NCT06252389尚未招募不适用

Treating Achilles Tendon Rupture Complicated by Pre-existing Tendinopathy With Repair Augmented With a Bioinductive Collagen Implant

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2025年2月1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
9
试验地点
1
主要终点
Foot and Ankle Outcome Score (FAOS)

研究概览

简要总结

Retrospective Case Series to investigate the effect a bovine collagen patch to augmented repair in acute Achilles tendon rupture with pre-existing tendinopathy

详细描述

Retrospective Case Series. Investigate the effect a bovine collagen patch to augmented repair in acute Achilles tendon rupture with pre-existing tendinopathy.

Acute Achilles tendon rupture patients all underwent pre-operative ultrasound; those with tendinopathy enrolled into study.

Standard Achilles tendon repair performed; augmented with a bioinductive collagen patch (Regeneten)

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

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

入选标准

  • Pre-operative ultrasound confirmation of tendinopathy

排除标准

  • Underwent lower limb intervention with past 3 months
  • Physical or psychological condition impairing ability to consent
  • Physical or psychological condition impairing ability to adhere to rehabilitation protocol
  • allergy to bovine material
  • pregnant individuals

结局指标

主要结局

Foot and Ankle Outcome Score (FAOS)

时间窗: 2 weeks, 6 weeks, 3 months, 6 months

Symptoms measured by the patient reported outcome measure FAOS. It is split into 5 sections including: Symptoms, Pain, ADL function, Sporting activity, and Quality of Life.

次要结局

  • Victoria Institute of Sports Assessment - Achilles (VISA-A)(2 weeks, 6 weeks, 3 months, 6 months)

研究者

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

Samuel KK Ling

Clinical Assistant Professor

Chinese University of Hong Kong

研究点 (1)

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