Prospective, Multicentric Study to Assess Stability of a Tapered Porous Coated Stem and a Cementless Hemispherical Acetabular Component
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- RSA imaging
研究概览
简要总结
This is a prospective, multicentric study that aim to assess stability of a tapered porous coated stem and a cementless hemispherical acetabular component.
Main Translation and rotation around the x., y-, and z-axis of the femoral and cup component by radiostereometric analysis (RSA) at immediate post op (within 5 days and before weight bearing), 6 months, 1year and 2 years
详细描述
Aim of this study is to assess stem and cup migration over the time in patient subjected to a total hip arthroplasty. Medical Device Research Australia will perform image analysis services and reporting for model based radiostereometric analysis (RSA) of cementless fixation of the femoral and acetabular cup components. Migration of the components will be measured with model-based RSA (MBRSA) at immediate post op (within 5 days and before weight bearing), 6 months, 1year and 2 years A subgroup of 26 patients will be invited to be evaluated also by additional RSA analysis: the first 13 patients for each investigator who will accept.
The results of this work will establish the mechanical stability of Masterloc femoral component (Medacta International SA) and MPACT acetabular component (Medacta International SA), provide a general estimate of survivorship, and establish clinical safety and efficacy as measured by RSA and clinical outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary osteoarthritis of the hip necessitating primary hip replacement,
- •Suitability for straight cementless stem,
- •Adult male and female under 70years old,
- •Ability to give informed consent,
- •Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up.
排除标准
- •Post-traumatic deformity in the affected hip,
- •Patient suffering by rheumatoid arthritis,
- •Patient suffering by congenital or developmental deformity,
- •Severe osteoporosis,
- •Earlier surgery in the hip to be operated on,
- •Perioperative fracture,
- •Personal disorders (dementia, alcohol or drug abuse etc) suspected of making completion of the trial uncertain,
- •Patients with a history of active infection
- •Pregnant women or those seeking to become pregnant
结局指标
主要结局
RSA imaging
时间窗: 2 years
All RSA analysis will be performed Computer Aided Design (CAD) based Roentgen Stereophotogrammetry Analysis (RSA). The micro-motion results will be calculated and reported as translations and rotations along and about the three anatomic axes. The subsidence of the hip stem is included in the results. The motion of the femoral stem and acetabular cup will be described in relation to the marker beads placed in the proximal femur and acetabular bone during surgery respectively. The first CAD based RSA examination (within 5 days and prior to weight bearing) serves as the reference baseline. All subsequent evaluations of micromotion are related to the relative position of the implanted medical device with respect to the bone (bone markers) at the time of the evaluation
次要结局
未报告次要终点