Observational Retrospective and Prospective Study on the Treatment of Lateral Proximal Femoral Fractures With Medical Device EBA2
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- EBA2 performance at day 90
研究概览
简要总结
This is an observational, retrospective and prospective study where subjects who have undergone surgery with EBA2 medical device for lateral proximal femoral fractures will be followed for data collection since the day before their surgery (retrospectively) until day 180 after surgery (retrospectively and prospectively).
This study is aimed at collecting data from patients who have already been treated with EBA2 nail. Data collection will cover the details of the fracture and surgery (from which the retrospective nature of the study), as well as details of follow up visits after surgery that patients routinely carry out up to 6 months (from which the prospective nature of the study).
The study will be conducted in three clinical sites in Italy.
详细描述
EBA2, the technological evolution of Endovis BA, is now available. The device was developed in conformity with Regulations 93/42/CE and 2007/47/CE, it has the CE trademark and it is registered in the Italian National Registry of Medical Devices. EBA2 has the unique features described below:
- it is undersized compared to other nails in commerce, both proximal and distal, to further facilitate the insertion into the bone. The undersizing is aimed to reduce the stiffness of the stem. In particular, the biological nail-bone interaction will be improved as a consequence of lower shear stresses on the frontal plane;
- it is made entirely of titanium. The choice of such a material is aimed to create a flexible means of synthesis that minimizes the differences with the healthy bone mechanical properties and reduces complications in the process of fracture healing;
- it is a dual-lag screw system that provides appropriate guidance to the sliding of the fractured extremities and an improved stability. It is effective to limit torsional instability of the femoral head, both during the intervention, by the action of tightening of the screw itself, and during the healing period due to improved bearing capacity towards multidirectional loads;
- the associated surgical instruments are simple; the low number of pieces and their ease of use made the success even of the previous version.
The aim of the present observational study is to collect data that confirm for EBA2, the technological evolution of Endovis BA, the performance and tolerability proved in the previous trial. In addition, given the increasing importance that good quality of life represents in elderly, objective of this observational study is to verify the general satisfaction of the patient with lateral proximal femoral fractures treated with EBA2.
In order to evaluate subject's walking ability after the surgical insertion of EBA2, only subjects who could walk independently before of the fracture will be included in this observational study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of both genders, aged ≥ 60;
- •Subjects with diagnosed lateral proximal femoral fractures who have undergone surgery with EBA2 nail;
- •Subjects with type 31A1, 31A2 or 31A3 fractures;
- •Subjects able to walk independently (with or without walking aids) before the fracture;
- •Subjects who sustained a low energy injury within 72 h prior the surgery;
- •Subjects who received a perioperative antibiotic therapy;
- •Subjects who received antithrombotic prophylaxis for 5 weeks;
- •Subjects who underwent rehabilitation procedure for 30 days at least;
- •Subjects who have been mobilized in the 2nd operation day;
- •Subjects able to attend the scheduled visits and to follow the instructions given by the physician;
- •Subjects who have given their written informed consent.
排除标准
- •Subjects with rheumatoid arthritis;
- •Subjects with fractures due to metastasis;
- •Subjects with fractures operated 72 h after the traumatic event;
- •Subjects with previous ipsilateral hip or femur surgery;
- •Subjects with ASA Physical Status Classification Class 5;
- •Subjects with Karnofsky performance status scale before fracture ˂ 80;
- •Subjects who have shown hypersensitivity to any of the components of EBA2;
- •Concomitant use of any other surgical device for the femoral fracture.
结局指标
主要结局
EBA2 performance at day 90
时间窗: Day 90
As a first primary endpoint, EBA2 performance will be assessed at 90 days. The performance will be assessed on the basis of failures, complications and malfunctioning related to the device. Since a centralized review will be performed, the extent of agreement between raters will be assessed using both Kappa statistic and AC1-statistic. Any discrepancy on the X-ray evaluation will be discussed between the raters and possibly with the Sponsor.
EBA2 performance at day 180
时间窗: Day 180
EBA2 performance will also be assessed at 180 days. The performance will be assessed on the basis of failures, complications and malfunctioning related to the device.
EBA2 performance at day 30 (optional primary endpoint)
时间窗: Day 30
EBA2 performance will be optionally assessed at 30 days. The performance will be assessed on the basis of failures, complications and malfunctioning related to the device.
次要结局
- SF12 Questionnaire(Day 30 (optional), 90 and 180)
- Clinical evaluation of pain(Day 30 (optional), 90 and 180)
- Radiographic examination(Day 30 (optional), 90 and 180)
- Walking ability data(Day 30 (optional), 90 and 180)
- Device-related adverse events(Up to day 180)