Prospective, Multi Centre Evaluation of AVANTAGE® RELOAD Double Mobility Acetabular Cup - Clinical and Radiographic Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- Survivorship
研究概览
简要总结
This is a Post Marketing Clinical Follow Up study (PMCF) on the AVANTAGE RELOAD dual mobility system cup.
详细描述
The study objective is to document the patients' survivorship at 10 years and evaluate the performances at 3 months, 1, 2, 3, 5, 7 and 10 years post-surgery of the AVANTAGE RELOAD cup. Secondary objective is to evaluate the polyethylene wear between E1 and ARCOM.
500 patients was the enrollment goal with 2 subgroups.
- Subgroup 1: prospective and non-controlled to satisfy ODEP (Orthopedic Device Evaluation Panel) requirements;
- Subgroup 2: randomized and controlled to compare the polyethylene wear between the Arcom and the E1 liners.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
The two subgroups will have the medical device with the following objectives:
Subgroup 1 Prospective non Controlled to Document long term performance of AVANTAGE® RELOAD.
Subgroup 2 Randomized Controlled Trial to Evaluate wear rate of E1 liner in comparison to ArCom® liner.
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
- •Selection of subjects for this evaluation should be in accordance with the indications of the AVANTAGE® RELOAD with E1™ or ArCom™ liner specifically
- •Primary osteoarthritis
- •Post-Traumatic arthritis
- •Inflammatory joint disease (e.g. Rheumatoid arthritis)
- •Femoral neck fracture
- •Femoral head necrosis
- •Sequelae from previous hip surgery, osteotomies, etc.
- •Congenital hip dysplasia
- •Additional inclusion criteria include:
- •Male or female
- •18 years of age or older
- •Subjects willing to return for follow-up evaluations
- •Subjects who read, understand study information and give written consent (specific local regulatory requirements)
排除标准
- •Exclusion criteria should be in accordance with Contraindications for the AVANTAGE®
- •Absolute contraindications include:
- •Infection
- •Severe muscular, neurological or vascular deficiencies of the extremity involved
- •Bone destruction or poor bone quality
- •Additional contraindications include:
- •Subjects unable to co-operate with and complete the study
- •Dementia and inability to understand and follow instructions
- •Neurological conditions affecting movement
- •Patient over 18 under law supervision
结局指标
主要结局
Survivorship
时间窗: 10 years post-surgery
Implant survivorship
次要结局
- EQ-5D(10 years post-surgery)
- Radiographic Evaluation(10 years post-surgery)
- Harris hip scores(10 years post-surgery)
- Complications(10 years post-surgery)