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临床试验/NCT02291900
NCT02291900Unknown不适用

Talar Avascular Necrosis: Surgical Angiogenesis Compared to Core Decompression With Osseous Auto Grafting

BG Trauma Center Ludwigshafen1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1
主要终点
Pain reduction

研究概览

简要总结

The purpose of this study is to determine if surgical angiogenesis performed in talar avascular necrosis by free microvascular bone grafts from the femoral condyle is a superior technique compared to core decompression and nonvascularized osseous autografts.

详细描述

The aim of this prospective randomized clinical trial is the comparison of two surgical treatment options for talar avascular necrosis (analogical to Ficat and Arlet stage II and III). The randomized study design allows direct comparability of the outcome after either core decompression and nonvascularized osseous autografting from the iliac crest or core decompression and osseous autografting with a free microvascular medial femoral condyle.

Talar avascular necrosis is caused by osseous malperfusion leading to malnutrition and destruction of the talar bone. The extend of this malperfusion is variable and can be categorized in 4 stages. The osseous defects can remain without consequences (stage I) or lead to irreversible talar destruction. The current treatment option for stage II and III is the core decompression followed by osseous auto grafting from the iliac crest. Reducing the intraosseal pressure and filling the drill holes with the bone graft can lead to reperfusion of the talus.

A new technique is to fill the drill hole with a vascularized bone graft from the medial femoral condyle, using microvascular anastomosis. This procedure has already been approved for the treatment of avascular necrosis and malperfusion of the carpus (lunate and scaphoid) as well as the femoral head.

Patients are examined preoperative as well as 3, 6 and 12 month after operation, documenting the active range of motion and pain sensation while resting and on activity. Well established scores like the AOFAS Ankle-Hindfoot Score and the Lower Extremity Functional Scale are used to get subjective and objective informations about patients' daily life and postoperative satisfaction. X-Rays are taken at the same stages. MRIs of the ankle joint with contrast agent are performed before as well as 6 and 12 months after surgery.

Statistical analysis is performed using the Statistical Package for the Social Sciences (SPSS). The Study protocol has been approved by the Ethics Commission of Rheinland-Pfalz. Interventions are done according to the declaration of Helsinki.

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 (Investigator)

入排标准

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

入选标准

  • •Avascular talar necrosis stage 2 and 3 (Ficat and Arlet)
  • •signed patient consent form

排除标准

  • •steroid or chemo therapy
  • •participation in a different study
  • •pregnancy
  • •peripheral artery occlusive disease stage 3 and 4
  • •avascular talar necrosis stage 1

研究组 & 干预措施

medial femoral condyle

Active Comparator

Patients in this arm receive core decompression followed by free vascularized medial femoral condyle graft

干预措施: core decompression (Procedure)

core decompression

Active Comparator

Patients in this arm receive core decompression followed by osseous autograft from the iliac crest

干预措施: core decompression (Procedure)

结局指标

主要结局

Pain reduction

时间窗: 3, 6, 12 months post operation

次要结局

  • Lower Extremity Functional Scale(pre operation; 3, 6, 12 month post operation)
  • Revascularization (Association International de Recherche sur la Circulation Osseuse-Criteria)(6 and 12 month postoperative)
  • American Orthopaedic Foot and Ankle Society- Ankle and Hindfoot Score(pre operation; 3, 6, 12 month post operation)

研究者

发起方
BG Trauma Center Ludwigshafen
申办方类型
Other
责任方
Sponsor

研究点 (1)

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