A Post-market Study Evaluating Clinical and Safety Outcomes of Unipolar Hemiarthroplasty Using Cephalic Femoral Heads in Subjects with Hip Fracture
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Evaluation of the revision rate of Cephalic femoral heads for any reason at 24 months after Unipolar Hemiarthroplasty.
研究概览
简要总结
Study design: monocentric, retrospective, observational and post-market clinical study.
Purpose: To demonstrate the safety and performance of cephalic femoral heads. The eligible study population is represented by the entire population that underwent a hip replacement with cephalic femoral heads from 1st January 2023 onwards at the site in accordance with the indication for use of the product.
详细描述
The study is aiming to demoranstrate safety and performance of cephalic femoral heads and will do it by considering the rate of revision of any prosthesis component and dislocation, by x-ray evaluation, by patient reported outcomes and walking/residential status. Patients are followed for 2 years after hemiarthroplasty and data are collected at 6 timepoints (pre-operative, intra-operative, at discharge, 4-months follow up, 12 months follow up and 24 months follow up).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Displaced intracapsular hip fracture (Garden III-IV).
- •Subjects underwent a Unipolar Hemiarthroplasty with a Cephalic femoral head as per their Indication For Use from January 1st, 2023, onwards.
- •No concurrent joint disease at the time of the surgery.
- •Absence of severe cognitive dysfunction demonstrated by 3 or more correct answers on the Pfeiffer test.
- •Ability to ambulate independently with or without walking aids before surgery.
- •Subject willingness to participate.
排除标准
- •Undisplaced or minimally displaced intracapsular hip fracture (Garden I-II).
- •Any Cephalic femoral head contraindication for use as reported in the current Instruction For Use.
- •Pathological fracture secondary to malignant disease.
- •Subjects with rheumatoid arthritis or symptomatic osteoarthritis.
- •Previous treatment to the same hip for a fracture at the time of the surgery.
- •Subjects who were deemed unsuitable for the surgical procedures by the anesthesiologist.
- •Severe cognitive dysfunction or cognitive impairment demonstrated by 2 or less correct answers on the Pfeiffer test.
- •Unable to walk before surgery (e.g., wheelchair or bed-ridden subjects).
结局指标
主要结局
Evaluation of the revision rate of Cephalic femoral heads for any reason at 24 months after Unipolar Hemiarthroplasty.
时间窗: From intraoperative to 24months follow up visit
次要结局
- Evaluation of the dislocation rate (including close reduction) in subjects with Cephalic femoral heads from intra-operative to 24 months after Unipolar Hemiarthroplasty.(From intraoperative to 24months follow up visit)
- Evaluation of the revision incidence of any hip component for any reason from intra-operative to 24 months after Unipolar Hemiarthroplasty.(From intraoperative to 24months follow up visit)
- Evaluation of acetabular erosion (according to Baker classification) in subjects with Cephalic femoral heads at 12 months after Unipolar Hemiarthroplasty.(12 months follow up visit)
- Assessment of Harris Hip Score (HHS) at 24 months after Unipolar Hemiarthroplasty with Cephalic femoral heads.(24 months follow up visit)
- Assessment of Oxford Hip Score (OHS) completed by subjects with Cephalic femoral heads at 24 months after Unipolar Hemiarthroplasty.(24 months follow up visit)
- Assessment of Pain Likert-scale in subjects with Cephalic femoral heads at 24 months after Unipolar Hemiarthroplasty.(24 months follow up visit)
- Comparison between pre-operative and 4-month walking ability.(Performed at preoperative visit to 4months follow up visit)
- Comparison between pre-operative and 4-month residential status.(Performed at preoperative visit and 4months follow up visit)