Prospective, Multi - Centre Clinical Evaluation of the Performance and Safety of the HYPERION Hip Endoprosthesis System in Defect Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- Pain and Walking Ability Determined by a Merle d' Aubigné Score Increase of >4 Points.
研究概览
简要总结
The study is a multi-center, prospective, non-controlled, consecutive cohort post market surveillance study. The objective of this study is to obtain survival and clinical outcome data on the Hyperion® system in primary and revision total hip arthroplasty.
详细描述
This multi-center, prospective, non-controlled, consecutive cohort post market surveillance study will serve the purpose of confirming long-term safety and performance of the Hyperion® system. The performance of the Hyperion® THA System will be evaluated using standard scoring systems (Merle d'Aubigné Score, HOOS Score). Safety will be evaluated by adverse event reporting.
The study will be performed at 6 sites, enrolling in total 70 patients. Follow-up visits are planned after 3 to 6 month, 1, 2 and 5 years. The scores will be filled in pre-operatively and post-operatively until 5 years. In order to obtain mid- to long-term patient satisfaction data the patient questionnaire will be send to the patient at 7 and 10 years, additionally. Xrays will be done pre-operatively, immediate post-operatively and at each of the Follow-up visits.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age at least 18 years
- •Fully conscious and capable patients
- •Signed informed consent
- •Stationary treatment
- •Merle d'Aubigné < 12 Points, WOMAC Score > 25 Points
- •Patients with at least one of the following indications:
- •Indications for primary hip replacement:
- •Non-inflammatory diseases of the joints such as osteoarthritis and avascular necrosis (head necrosis)
- •Rheumatoid arthritis
- •Functional deformities
- •Provision of non-endoprosthetic previous operations of the hip joint (e.g., transposition osteotomies)
- •Treatment of pseudarthrosis, femoral neck and trochanter fractures, as well as fractures of the proximal femur affecting the head, which can not be treated by other techniques
- •Revision THA:
- •Revision of endoprosthesis-treated hips as a result of septic or aseptic loosening, sub- and periprosthetic fractures or material failure (eg fracture of the prosthesis)
- •Bridging of large bone defects (precondition: suitable proximal bone situation for a stable anchorage), i.e. for tumors
排除标准
- •Infections
- •Patients under 18 years
- •Pregnant or breastfeeding patients
- •Known alcohol abuse (at least 20 g alcohol per day for women and at least 40 g per day for men) or drug abuse
- •Legal incapacity or restricted capacity
- •Participation in another clinical trial within the last 30 days or planned participation in another clinical trial within the next 3 months
- •Patients who are unable to attend to follow-up
结局指标
主要结局
Pain and Walking Ability Determined by a Merle d' Aubigné Score Increase of >4 Points.
时间窗: baseline/Pre-op and 2 years (+/- 2 months)
Pain and walking ability determined by a Merle d' Aubigné Score (MdA) increase of \>4 points compared to the pre-operative score points. The patients were evaluated by the Merle d'Aubigné hip score, which evaluates pain, gait and mobility, on a scale of 1 to 6 for each item, where 1 indicates the worst and 6, the best state of the patient. The value of each item is summed to a total score. The total minimum score reached is 3, and the maximum is 18. Higher scores mean a better outcome.
Implant Survival Measured by the Number of Revisions.
时间窗: 2 years (+/- 2 month)
Implant survival is measured by the number of revisions and analysed by the Kaplan Meier method.
WOMAC Score Value Decrease at 2-years in Min. 25 Points Compared to the Pre-operative WOMAC Score Value
时间窗: baseline/Pre-op and 2 years (+/- 2 months)
at 2-years post op, WOMAC score (Western Ontario and McMaster Universities Arthritis Index) has to be at least 25 points lower compared to preop values Scale: min 0-Max 100; Higher values mean worse outcome
次要结局
未报告次要终点