NL-OMON35432已完成不适用
Curved versus Straight Stem Uncemented Total Hip Arthroplasty Osteoarthritis Multicenter trial A prospective blinded randomised controlled multicentre trial comparing the CFP stem with straight stem total hip arthroplasties for the treatment of primary osteoarthritis of the hip. - CUSTOM trial
Onze Lieve Vrouwe Gasthuis0 个研究点目标入组 150 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
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
- •Male or female being 18 years or older
- •Patients meet the criteria for osteoarthritis:
- •-Pain in hip
- •-Arthritic changes on radiograph: joint space narrowing
- •femoral / acetabular osteofytes, cysts and signs of sclerosis
- •Patients not responding to conservative therapy
- •Written informed consent for study participation
排除标准
- •Patients who are mentally impaired and not able to fill out questionnaires
- •Patients who have previously received a THA on the contralateral hip.
- •Patients who do not know the Dutch, or English or German language
- •Patients with a BMI of more than 40
- •Patients with skeletal immaturity
- •Patients with a life expectancy of less than 3 years
- •Patients with altered anatomy resulting in impossibility for the CFP procedure, according to the surgeon e.g.:
- •-hip dysplasia with high luxation
- •-post traumatic severe anatomy change
- •-post correction osteotomy
- •Patients with extremity amputation
- •Patients with an active malignant disease or current cytostatic treatment
- •Patients who are participating in another trial
- •Known alcohol or drug abuse
- •Any condition that would impede measurement of efficacy to the opinion of the surgeon
- •Patients with a previous contralateral hip arthroplasty
- •Patients with avascular head necrosis resulting from sickelcel anemia
研究者
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