NCT02635581已完成不适用
A DEXA Clinical Study to Evaluate the Osteointegrative Potential of Trabecular Titanium™
Limacorporate S.p.a8 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2008年12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
- 84
- 试验地点
- 8
- 主要终点
- The percentage change of the bone mineral density (BMD) around the acetabular cups with DEXA scan
研究概览
简要总结
The purpose of this clinical trial is to evaluate the osteointegrative potential of the Trabecular TitaniumTM and to measure the pattern of changing in bone mineral density (BMD) around an uncemented acetabular cup, manufactured in Trabecular Titanium™ , during 60 months after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI< 40 kg/m2
- •Indication suitable to the implantation of Delta TT acetabular cup (First implant)
- •Idiopathic osteoarthritis
- •Avascular necrosis
- •Post-traumatic arthritis
- •Presence of sufficient periacetabular bone stock
- •Ability to understand the investigation, cooperate with the investigational procedure and willing to return to the hospital for the required post-operative follow-ups
- •Written informed consent
排除标准
- •Patients found unsuitable for an implantation of Delta TT acetabular cup (Revision)
- •Patients aged 76 or older
- •Haemophilic disease
- •Femur neck fracture
- •Insulin Dependent Diabetes Mellitus (IDDM)
- •Severe kidney failure (grade 4)
- •Not responder Hypo- or Hyperthyroidism
- •Paget's disease
- •Active or suspicious infections
- •Neurosensory deficits or neuromuscular diseases
- •Severe and impairing vascular diseases
- •Known incompatibility or allergy to products materials
- •Woman with pregnancy or childbearing capacity or breast-feeding
- •Subjects already enrolled in other clinical trials
结局指标
主要结局
The percentage change of the bone mineral density (BMD) around the acetabular cups with DEXA scan
时间窗: From baseline to 5 year Follow-up
次要结局
- Harris Hip Score (HHS)(From baseline to 5 year Follow-up)
- SF-36 score(From baseline to 5 year Follow-up)
研究者
研究点 (8)
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