NL-OMON55494已完成不适用
SuperPath® a pilot study - Superpath pilotstudy
Reinier Haga Orthopedisch Centrum0 个研究点目标入组 6 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patient is 18 to 75 years of age, inclusive
- •Patient is able to speak and write Dutch
- •Patient qualifies for primary unilateral total hip arthroplasty
- •(THA) based on physical exam and medical history including at least one of
- •the following:
- •o Osteoarthritis
- •o Avascular necrosis (AVN)
- •o Inflammatory arthritis
- •o Rheumatoid arthritis with adequate bone quality
- •o Post-traumatic arthritis
- •o Congenital hip dysplasia., •Patient has no history of previous total hip
- •replacement or arthrodesis of the affected hip
- •Patient is willing and able to provide written informed consent.
排除标准
- •Subjects will be excluded when they meet one or more of the following
- •contra-indications for the SuperPath® technique:
- •Infection, sepsis, and osteomyelitis
- •Patients with a low femoral offset
- •Uncooperative patient or patient with neurologic disorders who are incapable
- •of following directions
- •Insufficient bone stock to provide adequate support and/or fixation to the
- •Metabolic disorders which may impair bone formation
- •Osteomalacia
- •Distant foci of infections which may spread to the implant site
- •Rapid joint destruction, marked bone loss or bone resorption apparent on
- •roentgenogram
- •Vascular insufficiency, muscular atrophy, neuromuscular disease ,
- •Additionally, subjects will be excluded when they meet the following exlusion
- •Patients with emergency or semi-emergency THA (e.g. for treatment of femoral
- •neck fractures)
- •Patient has a known or suspected sensitivity or allergy to one or more of the
- •implant materials
- •Revision THA surgery of the ipsilateral side
- •Contralateral THA <6 months before current surgery
研究者
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