A Prospective and Retrospective Multicenter Registry for Surgeon-based Evaluation of the "Quadrilateral Surface Plate" Used for Acetabular Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 6
- 主要终点
- Surgical treatment-related Adverse Events
研究概览
简要总结
The absence of methodologically, prospectively and retrospectively collected information on the use of the Quadrilateral Surface Plate (QSP) in the given indication requires a multicenter approach. Using a registry to get more information about the effectiveness and possible benefits or complications during the surgery and during the post-operative treatment is adequate and necessary to get new insights to the use of the Quadrilateral Surface Plate.
详细描述
This registry includes six visits at which data is collected form the patinet (pre-op, post-op, 6 weeks FU, 3 months FU, 6 months FU and 12 months FU). Patients can be inlucded prospectively or retrospectively. If properatively recruited patients complete two questionnaires (EQ5D and Merle d'Aubigné) at their preoperative visits. These questionnaires are repeated after 6 and 12 months. Surgeons report about the success of the surgical procedure in a specifically designed questionnaire.
During the whole study period, adverse events related to the implant or surgery are collected as well as x-rays and CT (as per standard of care).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Age 18 years or older
- •Diagnosis of acetabular fracture requiring surgical fixation
- •Ability to understand the content of the patient information / informed consent form
- •Signed and dated IRB/EC-approved written informed consent
排除标准
- •Any not medically managed severe systemic disease
- •Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
- •Participation in any other medical device or medicinal product registry within the previous month that could influence the results of the present registry
- •Intraoperative exclusion criteria:
- •Intraoperative decision to use implants other than the device under investigation
结局指标
主要结局
Surgical treatment-related Adverse Events
时间窗: Intra-operative
Collection of (Serious) Adverse Events related to the surgical treatment of the acetabular fracture.
次要结局
- Surgical treatment-related Adverse Events till 12 months(post-operative)
- Surgical treatment-related Adverse Events till 24 months(post-operative)
- Surgical treatment-related Adverse Events till discharge(post-operative)
- Surgical treatment-related Adverse Events till 6 weeks(post-operative)
- Surgical treatment-related Adverse Events till 6 months(post-operative)
- Changes in Quality of Life(Post-op till Hospital Discharge; 6 weeks; 3, 6, 12 and 24 months post-operative)
- Fracture Healing(Post-op till Hospital Discharge; 6 weeks; 3, 6, 12 and 24 months post-operative)
- Surgical treatment-related Adverse Events till 3 months(post-operative)