A Prospective Study to Investigate Postoperative Real Life Weight Bearing Measured in Patients Treated With a Trochanter Fixation Nail Advanced (TFNA)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Weight bearing
研究概览
简要总结
This study documents real life weight bearing in patients treated with a TFNA, who are allowed for immediate weight bearing as tolerated.
详细描述
Prospective data will be collected from 30 patients presenting a per- or inter-trochanteric fracture of the femur treated with the TFNA. Post-operatively patients will be asked to wear a sensor insole in their shoes for up to 3 months after surgical treatment. The sensor insole will be used in both feet and will not have any impact in patient's activities of daily living while allowing real time measurements of weight bearing.
In addition to weight bearing measurements, perceived pain (numeric rating scale), mobility (Parker Mobility Score and Time Up and Go Test) will be assessed at 6 and 12 weeks after surgical treatment and in conjunction with the standard (routine) of care follow up schedule. In order to investigate the relationship between these variables and the weight bearing measurements, patients or their care takers or assisting family members will be asked to document the daily use of the insole in a diary.
Finally, over the course of the study, anticipated adverse events (AE) that may affect the healing process will be collected. Special attention will be given to implant- or bone-related AEs. Images from patients with implant- or bone related AEs will be collected 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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older
- •Patients treated with the TFNA; i.e. according to the technique guide and the indications for use, patients who presented any of the following conditions:
- •Stable or unstable pertrochanteric fractures
- •Intertrochanteric fractures
- •Basal neck fractures
- •Combinations of pertrochanteric, intertrochanteric, and basal neck fractures
- •Patients who were able to walk before the fracture and are prescribed full weight bearing as tolerated post-surgery
- •Ability to understand the content of the patient information / informed consent form
- •Willingness and ability to participate in the study according to the clinical investigation plan
- •Signed and dated ethical committee approved written informed consent according to the local regulations
排除标准
- •Patients who are not allowed to full weight bearing as tolerated post-surgery
- •Any condition, which impairs weight bearing (e.g. additional acute fracture on the ipsilateral and/or contralateral side, pain)
- •Patients, who due to their condition, are in opinion of the Prinicipal Investigator (PI) unable to complete a reliable assessment
- •Pregnancy or women planning to conceive within the study period
- •Participation in any other medical device or medicinal product registry within the previous month that could, in opinion of the PI, influence the results of the present study
结局指标
主要结局
Weight bearing
时间窗: 3 months
Time course of the weight bearing difference between the operated and the healthy legs within 3 months after surgery.
次要结局
未报告次要终点