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临床试验/NCT02237482
NCT02237482已完成不适用

Is the Trabecular Metal Cup Associated With Lower Risk of Aseptic Loosening in Acetabular Revision Surgery?

Sahlgrenska University Hospital, Sweden1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2006年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Proximal migration measured with RSA

研究概览

简要总结

This study is intended to compare the proximal migration of the tantalum design (TM) with a cemented cup used in conjunction with bone allografting in cases with major bone loss. A group of patients with good periacetabular bone stock are included to analyse the differences between the tantalum and titanium design regarding risk of loosening and differences in clinical outcome measures. Radiostereometry (RSA) is used to accurately measure migration and rotation of the revision cups.

详细描述

Acetabular component loosening is often associated with periacetabular bone loss. Different approaches are described to address the bone defects in acetabular revision surgery. Several authors have reported inferior results when uncemented Titanium alloys and older porous coated designs are used in acetabular revisions with significant bone loss. Cemented fixation of the revision cup with impaction bone grafting (BIG), introduced more than three decades ago has today a thorough documentation. The Tantalum designs, with inherent properties such as high volumetric porosity, low modulus of elasticity and high friction against the bone, have been suggested to improve the fixation of the acetabular component. Several authors have been reporting promising short- and medium-term results using the TM designs in acetabular revisions with large periacetabular bone defects. Proximal migration measured with radiostereometry (RSA) has been suggested to predict risk for late aseptic loosening in hip prosthesis surgery. This study was primarily to compare the proximal migration of the tantalum design with a cemented cup used in conjunction with bone allografting in cases with major bone loss. A group of patients with good periacetabular bone stock are included to analyse the differences between the tantalum and titanium design. RSA is used to accurately measure migration and rotation of the revision cups.

研究设计

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

入排标准

年龄范围
— 至 85 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients with a loose acetabular component, undergoing revision

排除标准

  • Patient not able to understand the intention of the study

结局指标

主要结局

Proximal migration measured with RSA

时间窗: 24 month postoperatively.

All patients have been recruited (operated on) by end of December 2011. Our primary intention is to follow all patients a minimum of two years with RSA.

次要结局

  • Patient reported outcome measures(first two years postoperatively)

研究者

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

Maziar Mohaddes Ardebili

M.D.

Sahlgrenska University Hospital, Sweden

研究点 (1)

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