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临床试验/NCT07747831
NCT07747831尚未招募不适用

Demonstrating the Effect of Powered Broaching and Impaction in Direct Anterior Total Hip Arthroplasty. A Multi-centre Comparison of Patients 70 Years and Older

Nova Scotia Health Authority2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
2
主要终点
Incidence of Periprosthetic fracture

研究概览

简要总结

Placing the parts of a hip replacement requires substantial force. This can lead to additional stress on the surgeon as well as the bone. A device was developed to help reduce this stress. This study aims to see whether this device impacts implant positioning and the surrounding bone in patients 70 years and older. It also will investigate surgeon efficiency and how patients walk after surgery.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 70 years or older undergoing total hip replacement

排除标准

  • Unable to undergo the informed consent process

研究组 & 干预措施

Total Hip Replacement with KINCISE2

Experimental

Standard direct anterior total hip replacement with KINCISE2

干预措施: Total Hip Replacement with Automatic impaction and broaching device (Procedure)

Total Hip Replacement

Active Comparator

Standard direct anterior total hip replacement

干预措施: Total Hip Replacement (Procedure)

结局指标

主要结局

Incidence of Periprosthetic fracture

时间窗: 90 days

Intraoperative or early postoperative femoral/acetabular fractures in patients 70 years or older, when compared to traditional manual techniques in DA THA. * Measured via intraoperative reporting of fracture by surgeon (Yes/No), the postoperative CT scan by the radiologist (Yes/No) (CT scan performed within 1 week of operation) and by the radiograph at 3 months/90 days by the surgeon (Yes/No) * Outcome end point: 3 months/90 days (i.e. no fracture within 90 days of surgery)

次要结局

  • Gait analysis(90 days)
  • Image based implant positioning(7 days)
  • Surgical efficiency(1 day)
  • Surgical stress as measured by heart rate(1 day)
  • Surgical stress as measured by respiratory rate(1 day)
  • Patient reported outcome measure(90 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jhase Sniderman

Orthopaedic Surgeon

Nova Scotia Health Authority

研究点 (2)

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