Prospective Single-center Long-term Observation of the SL-PLUS® MIA Stem
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 主要终点
- Survival, Kaplan Meier
研究概览
简要总结
Summary from initial protocol
Goal: Validation of the uncoated SL-PLUS® MIA stem within an observation study
Study design: prospective, single-center, observational, non-comparative study
Study population: 135 consecutive cases (uncoated SL-PLUS® MIA implants)
Intervention (if applicable): Implantation of a total hip endoprosthesis
Main goals/endpoints: Radiological: radiolucent lines, osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration; clinical: Harris Hip Score, implant-related complications, revisions; patient questionnaire (WOMAC)
Type and extent of the risks associated with the study participation as well as benefits for the patient: All patients will benefit from the hip prostheses without exception. There are no increased risks for the patients participating in the study compared to patients who do not participate. Normal, necessary follow-up exams will be performed over the course of 10 years. These follow-up exams will then be quantitatively evaluated within the scope of the study in accordance with a standardized protocol. Accordingly, the benefit for the patients from the participation in the study is currently not yet foreseeable.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with primary or secondary hip osteoarthritis
- •Patients scheduled for a first implantation
- •Age at the time of surgery 40-80 years
排除标准
- •Destruction of the acetabulum
- •Deformation of the hip joint
- •Deformation of the proximal femur
- •Revision of failed hip endoprostheses
- •Acute or recent infection of the joint or its surrounding region
- •Acute or chronic systemic infections
- •Marked atrophy or deformation of the upper femur
- •Muscle atrophy or a neuromuscular disease
- •Pathological fractures
- •Per- to subtrochanteric fractures
- •Conditions that would prevent secure anchoring of the hip prosthesis
- •Obese patients with a BMI >35
- •Patients not expected to have a successful rehabilitation
结局指标
主要结局
Survival, Kaplan Meier
时间窗: up to 10 years after implantation
Survival rate: Rate of hip implants in situ after 10 years of follow-up.
Postoperative AE up to 10 years after the surgery
时间窗: up to 10 years after implantation
Rate of hip implants experiencing Postoperative AE up to 10 years after the surgery Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects
Intra- und perioperative implant-related "Adverse Events" (AE) and complications until discharge
时间窗: up to patient's discharge from the hospital/clinic (from surgery up to 7 days after surgery)
Rate of hip implant experiencing intra- und perioperative implant-related "Adverse Events" (AE) and complications until discharge. Rate of hip implants with Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects
次要结局
- Harris Hip Score(up to 10 years after implantation)
- Radiographic changes defined as radiolucent lines, osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration.(up to 10 years after implantation)