Radiostereometric Analysis (RSA) of the PROFEMUR® Preserve Classic Femoral Components
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Assess the stability of the PROFEMUR® Preserve Classic stem with RSA to estimate its long-term performance.
研究概览
简要总结
MicroPort Orthopedics (MPO) is conducting this study to investigate the primary stability of its PROFEMUR® Preserve Femoral Components using radiostereometric analysis (RSA). RSA allows precise measurement of micromotion around orthopedic implants and hence, may estimate long-term fixation to bone.
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
- 21 Years 至 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is a candidate for primary THA for osteoarthritis
- •Subject is able to undergo primary THA procedure
- •Subject is a candidate to be implanted with the specified combination of components
- •Subject is willing and able to complete required study visits and assessments
- •Subject is willing to sign the approved Informed Consent document
排除标准
- •Subject has any of the following contraindications at the time of the implantation:
- •Overt infection;
- •Distant foci of infections (which may cause hematogenous spread to the implant site);
- •Rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram;
- •Skeletally immature (less than 21 years of age at time of surgery);
- •Inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable;
- •Subjects 76 years of age or older
- •Subjects with post-traumatic arthritis in the affected hip
- •Subjects with rheumatoid arthritis in the affected hip
- •Subjects with hip dysplasia in the affected hip
- •Subjects with prior arthroplasty of the affected hip
- •Subjects that are morbidly obese (BMI > 35)
- •Subjects that are immuno-suppressed
- •Subjects with known or tested-positive allergy to metals
- •Subjects currently enrolled in another clinical investigation which could affect the endpoints of this protocol
- •Subjects unwilling or unable to sign the Informed Consent document
- •Subjects with substance abuse issues
- •Subjects who are incarcerated or have pending incarceration
结局指标
主要结局
Assess the stability of the PROFEMUR® Preserve Classic stem with RSA to estimate its long-term performance.
时间窗: 24 months
Assessment of the quantity of migration to determine if the total migration of the stem and cup at 2 years post¬operatively are less than 1.2 mm and 2.6mm, and also less than 0.4mm. Assessment of continuous migration to determine if continuous migration, defined as 0.2mm of motion between 1 and 2 years as measured with RSA exists in the stem and cup.
Assess if migration pattern is greater than 0.2mm between 1 and 2 years
时间窗: 24 months
To determine if the wear rate device is substantially less than the scientifically accepted threshold of 0.1 mm/year for osteolysis. The outcomes will be compared to data from the literature, which states that motion greater than 0.2mm between 1 and 2 years suggests an implant is at risk for early loosening.
Determine the migration patterns of the PROFEMUR® Preserve Classic stem with RSA
时间窗: 24 months
Assessment of migration in each individual plane (x, y, and z), as measured in mm.
次要结局
- Patient functional outcomes (HOOS)(24 months)