Assessing the Wear Rates of the ADM/MDM Dual Mobility Hips Manufactured by Stryker Orthopaedics Using 3D X-ray Analysis
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- To assess the change in polyethylene wear of Dual Mobility hip implants using Stryker Orthopaedics ADM & MDM prostheses
研究概览
简要总结
A common complication post hip replacement is hip dislocation or hip instability which can lead to the hip implants being revised. A new generation of Dual Mobility hips was designed to minimize hip dislocation/hip instability and polyethylene wear thus increasing the longevity of the hip prosthesis and reducing the number of re-operations for a patient. In this study we will be assessing 2 dual mobility hips manufactured by Stryker Orthopaedics Inc. The ADM and the MDM.
详细描述
Hip replacement is a procedure in which the hip joint is replaced by a prosthetic implant or prosthesis. Post op hip dislocation or hip instability is a common complication which can lead to the hip implants being revised. There are many types of hip prostheses manufactured with the aim of prolonging longevity of the prosthesis and minimizing postoperative complications. One of these is a new generation of dual mobility hip manufactured by Stryker Orthopaedics. The Anatomic Dual Mobility (ADM) and the Modular Dual Mobility (MDM) were designed to minimize hip dislocation/hip instability and polyethylene wear thus increasing the longevity of the hip prosthesis and reducing the number of re-operations for a patient. In this study we will be assessing the outcome of the ADM and MDM hip system.
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
- 是
入选标准
- •Male or non-pregnant female
- •Skeletally mature
- •18 to 75 years old
- •Stryker Dual Mobility Hip prosthesis
- •BMI between 20 and 35
- •Follow-up x-rays between 3 years and 6 years postop
排除标准
- •Dual Mobility Hip implant that is not the ADM or MDM
- •BMI that is 19 or less
- •BMI that is greater than 36
- •Most recent x-rays less than 3 years postop
研究组 & 干预措施
ADM/MDM hip prosthesis
Type of prosthesis participant received.
干预措施: ADM/MDM hip (Device)
结局指标
主要结局
To assess the change in polyethylene wear of Dual Mobility hip implants using Stryker Orthopaedics ADM & MDM prostheses
时间窗: before the patient's discharge home, 6 weeks postop, and the most recent x-ray taken up to 5 years postop.
This study will assess the change in linear and volumetric wear using 3D x-ray analysis. Measurements will be taken of x-rays obtained before the patient's discharge home, 6 weeks postop, and the most recent x-ray taken more than 3 years postop.
次要结局
- To review the number of postop hip dislocations/hip instabilities(first 5 years post surgery)