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临床试验/NCT02996253
NCT02996253进行中(未招募)不适用

Endoscopic Assisted Transfer of Flexor Hallucis Longus Tendon for Chronic Achilles Tendon Rupture. A Prospective Multi Center Cohort Study

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2015年12月最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
38
试验地点
1
主要终点
The Victorian Institute of Sports Assessment- Achilles Questionnaire (VISA-A) outcome score

研究概览

简要总结

The transfer of Flexor Hallucis Longus (FHL) in the management of chronic Achilles tendon ruptures has demonstrated good functional outcome, but an extensive surgical field at a vulnerable location may lead to increased risk for soft tissue problems. The arthroscopic FHL transfer may reduce the risk for soft tissue problems. Functional outcome parameters are investigated, wound/soft tissue complications registered.

详细描述

The transfer of FHL in the management of chronic Achilles tendon ruptures has demonstrated good functional outcome with American Orthopaedic Foot ane Ankle Society (AOFAS) hindfoot scores at 80-89. The extensive surgical field by either a two-incision approach or a single longitudinal posterior approach to the Achilles tendon may lead to an increased risk for soft tissue problems, both infections and wound healing problems. The endoscopic FHL transfer may reduce the risk for soft tissue problems while retaining a good functional outcome. Several functional outcome measures and scores are evaluated a year after surgery.

Prospective study for evaluation of the surgical procedure.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic Achilles Tendon Rupture

排除标准

  • Pregnancy
  • BMI<18.5 or >39.9
  • Insufficient Norwegian Language proficiency lack of communication skills local skin conditions at site for planned surgery

结局指标

主要结局

The Victorian Institute of Sports Assessment- Achilles Questionnaire (VISA-A) outcome score

时间窗: one year after FHL transfer

次要结局

  • patient reported function score (PRFS)(6, 12 months)
  • functional test battery(12 months)
  • Magnetic resonance imagine (MRI)(one year post surgery)
  • AOFAS hindfoot(3,6,12 months)
  • VISA-A(6 months after surgery)
  • Visual Analogue Scale for Pain (VAS pain) score(3, 6 and 12 months after FHL transfer)
  • local wound conditions(within 12 weeks)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elisabeth Ellingsen Husebye

MD, PhD

Oslo University Hospital

研究点 (1)

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