Clinical Observation Study of the Hydroxylapatite-coated SL-PLUS™ Hip Shaft
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- WOMAC Osteoarthritis Index
研究概览
简要总结
Summary from initial protocol
Goal: Validation of the HA (hydroxylapatite) coated SL-PLUS™ stem within an observation study
Study design: prospective, multicenter, observational, non-comparative study
Study population: 240 consecutive cases (HA-coated implants), 60 cases per study site
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 questionnaires HOOS and EQ-5D
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary total hip endoprosthesis of the side affected (unilateral or bilateral)
- •Patient shall be provided with a HA-coated SL-PLUS™ stem
- •Patient has no general medical contraindications regarding the surgery
- •Signed informed consent form for the participation in the study
- •X-ray examinations are possible
- •Patient is willing to participate in the post-operative follow-up program
- •Age: 18-75 years
排除标准
- •Previous failed hip joint surgery (endoprosthesis) of the side affected
- •Previous infections in the joint affected; systemic infections
结局指标
主要结局
WOMAC Osteoarthritis Index
时间窗: up to 10 yeares after implantation
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on I off toilet, heavy domestic duties, light domestic duties
EuroQuol-5D questionnaire
时间窗: up to 10 years after implantation
EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal
Postoperative AE up to 10 years after the surgery
时间窗: up to 10 years after implantation
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: from surgery up to 7 days after surgery
Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects
Survival, Kaplan Meier
时间窗: up to 10 years after implantation
Hip implants in situ after 10 years of follow-up
Harris Hip Score
时间窗: up to 10 years after implantation
The Harris Hip Score (HHS) is a clinician-based outcome measure frequently used for the evaluation of patients following a total hip arthroplasty. The score considers information on pain, function and range of motion. The scale ranges from 0 - 100 whereas, a higher score indicates a favorable outcome.
次要结局
- Radiographic changes(up to 10 years after implantation)