Is Use of the Watson Extraction System Associated With Reduced Operative Time and Safer Stem Extraction? - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Timing of surgery
研究概览
简要总结
A revision total hip replacement surgery requires the surgeon to remove, or extract, the femoral stem (the rod that was placed into the thigh bone during your first hip replacement). A variety of tools and techniques can be used to do this. At The Ottawa Hospital (TOH) surgeons attempt to remove the stem using less invasive measures, such as osteotomes, a tool that separates the stem from the bone, but if it doesn't work, they may need to perform an extended trochanteric osteotomy (ETO). An ETO is more invasive and increases the risk of complications.
The Watson Extraction System (WES) is another Health Canada approved tool that goes around the stem to help remove the femoral stem from the thigh bone. Research shows that the WES has been studied in case series of a few people, and the results seem promising, reducing the time of extraction and need for ETO. However, it is not clear if it offers better results than what is currently done at TOH.
The purpose of this study is to compare the WES to the current/usual care care at TOH to determine whether the WES can remove the femoral stem more efficiently (in less time and at a lower hospital cost) and effectively, while improving patient safety.
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
- Single (Participant)
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
- •Over 18 years of age
- •Undergoing revision Total Hip Arthroplasty for septic or aseptic indications
- •Have well-fixed femoral components, of blade-stem design (collared and collarless)
排除标准
- •Tapered stem in situ less than 4 months
- •Cemented Stems
- •Femoral Stems with Trunnions > 14mm
- •Femoral Stems of alternative design not compatible for use with the WES
研究组 & 干预措施
Watson Extraction System (WES)
Participants randomized to this arm will undergo stem extraction utilizing the WES in addition to other standard of care equipment, as required. Surgeons will use the WES device for extraction first.
干预措施: Watson Extraction System (Device)
Current Standard of Care at TOH
Participants randomized to this arm will undergo stem extraction as per surgeon preference with the use of K-wires, burr and flexible osteotomes. An ETO will be performed as per surgical judgement.
干预措施: Standard of Care Stem Extraction (Procedure)
结局指标
主要结局
Timing of surgery
时间窗: From surgery start to surgery close
The time it take to complete the surgery, including the femoral stem extraction
Time of Femoral Stem Extraction
时间窗: From start of femoral stem extraction to end of femoral stem extraction, up to 60 minutes
Amount of time, in minutes, it takes to remove the femoral stem during surgery
次要结局
- Intraoperative complication rate(From surgery start to surgery close)
- Postoperative Complication Rate(From end of surgery to 3 months postoperative)
- Change in Patient Reported Outcomes from baseline to 3 months(Baseline and at 3 month following surgery)
- Cost of OR time and resources(From start of surgery to end of surgery)
- Cost of complications(From end of surgery to 3 months postoperative)