Powered Impaction and Broaching in Elderly Total Hip Arthroplasty
Demonstrating the Effect of Powered Broaching and Impaction in Direct Anterior Total Hip Arthroplasty. A Multi-centre Comparison of Patients 70 Years and Older
研究概览
地位
详细说明
Preparation of the femoral canal and acetabulum impaction have traditionally been accomplished with the use of a mallet and manual instruments. During manual broaching or impaction, force is transmitted with each mallet strike, which distributes horizontal forces to cortical bone. Excessive force and malalignment of instruments can lead to intraoperative fractures, or unrecognized fractures contributing to early failure of the total hip arthroplasty (THA). This risk can be elevated in direct anterior (DA) THA when exposure is compromised due to the minimally invasiveness of the approach. The advent of powered broaching devices which provide a consistent force and are more ergonomic, now provide an alternative to manual techniques. Despite its proposed benefits, it has yet to achieve widespread adoption.
The study aims to assess whether the use of a powered broaching device (KINCISE2) has an impact on intraoperative or early postoperative femoral or acetabular fractures in patients 70 years or older, when compared to traditional manual techniques in DA THA. Patients will be subgrouped based on femoral/acetabular bone quality/morphology. Secondary outcomes measured will consist of femoral canal fil, femoral version and acetabular cup-floor gap and gait analysis measures via markerless motion capture. Surgical efficiency will be measured via operative time, broaching/impaction time and surgical stress via biometric monitoring. PROMs will be measured via the short form Hip disability and Osteoarthritis Outcome Score (HOOS-Jr). Surgeons can use a standard OR table vs. a specialized traction table (HANA) and may use fluoroscopy or no intraoperative imaging.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Jhase Sniderman
- 电话号码：9029323130
- 邮箱：jhase.sniderman@nshealth.ca
学习地点
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Manitoba
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Winnipeg、Manitoba、加拿大、R2K 2M9
- Concordia Joint Replacement Group / Concordia Hospital
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接触：
- Trevor Gascoyne
- 电话号码：(204) 926-1200
- 邮箱：tgascoyne@orthoinno.com
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Nova Scotia
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Halifax、Nova Scotia、加拿大、B3H1C3
- Nova Scotia Health
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接触：
- Jhase Sniderman
- 电话号码：9029323130
- 邮箱：jhasesniderman@gmail.com
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-
参与标准
资格标准
适合学习的年龄
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Patients 70 years or older undergoing total hip replacement
Exclusion Criteria:
- Unable to undergo the informed consent process
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Total Hip Replacement
Standard direct anterior total hip replacement
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Total hip replacement without automatic impaction and broaching
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实验性的：Total Hip Replacement with KINCISE2
Standard direct anterior total hip replacement with KINCISE2
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Total hip replacement with the use of an automatic impaction and broaching device
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of Periprosthetic fracture
大体时间：90 days
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Intraoperative or early postoperative femoral/acetabular fractures in patients 70 years or older, when compared to traditional manual techniques in DA THA.
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90 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Gait analysis
大体时间：90 days
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Preoperative and postoperative markerless motion capture at 3 months - gait speed, gait symmetry, cadence, step length, stance-time symmetry and hip flexion extension
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90 days
|
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Image based implant positioning
大体时间：7 days
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Measured via femoral canal fill, femoral version, acetabular floor-cup gap on postoperative CT scan
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7 days
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Surgical efficiency
大体时间：1 day
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Measured via operative time (minutes), broaching time (minutes), impaction time (minutes)
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1 day
|
|
Surgical stress as measured by heart rate
大体时间：1 day
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Measured via biometric assessment with wearable technology by the surgeon (Heart rate - beats per minute)
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1 day
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Surgical stress as measured by respiratory rate
大体时间：1 day
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Measured via biometric assessment with wearable technology by the surgeon (respiratory rate - breaths/minute)
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1 day
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Patient reported outcome measure
大体时间：90 days
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HOOS-JR (Hip Osteoarthritis Outcome Score - Joint Replacement).
Scale is 0-100, with zero the worst possible hip problem and 100 being no hip problem.
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90 days
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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