Comparing Mortality, Revision Rates, and Patient-Reported Outcomes With Different Stem Lengths of the Lubinus SPII Cemented Hip Stem: A Target Trial Emulation.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 110,000
- 试验地点
- 2
- 主要终点
- Mortality rate
研究概览
简要总结
The research questions this study aims to answer are as follows:
Primary research question:
"Do primary total hip arthroplasties for patients with OA, hip fracture or osteonecrosis with the 150mm Lubinus SPII hip stem have better mortality and stem revision rates than primary total hip arthroplasties with the 130mm hip stem?"
Secondary aims include:
- How does line-to-line cementation, compare to undersized cementation in primary total hip arthroplasty for patients with OA, hip fracture, or osteonecrosis when comparing equal size Lubinus SPII hip stems implanted with different cementation techniques?
- Does the Lubinus SPII 150mm hip stem perform equal to the Lubinus SPII 130mm hip stem in primary total hip arthroplasties for patients with OA, hip fracture or osteonecrosis when comparing patient reported outcome measures?
To answer these questions, this study has been allowed use of registered data from the LROI (dutch arthroplasty registry) and the SAR (swedish arthroplasty registry). After exclusion of patients who did not meet inclusion criteria between 2007-2020, approximately 110000 patients remain eligible for analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 5 Years 至 105 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Listed in registry for primary hip arthroplasty.
- •Listed in registry with an indication of osteoarthritis, osteonecrosis or hip fracture.
- •Received the Lubinus SPII hip stem, 130mm or 150mm, for their primary hip arthro- plasty.
- •End point listed in registry (Alive, Deceased or revision).
排除标准
- •Patients who received the Lubinus SPII 150 XL conus stem.
研究组 & 干预措施
Primary hip replacement patients
Patients who have received primary hip replacement therapy with an indication of osteoarhritis, osteonecrosis or fracture.
干预措施: Lubinus SPII hip stem 130mm (Procedure)
Primary hip replacement patients
Patients who have received primary hip replacement therapy with an indication of osteoarhritis, osteonecrosis or fracture.
干预措施: Lubinus SPII hip stem 150mm (Procedure)
结局指标
主要结局
Mortality rate
时间窗: From date of surgery to date of event (death), minimally 2 years up to 16 years (2007-2023)
Time from primary hip surgery to patient death, per hip stem length
Revision rate
时间窗: From date of surgery to date of event (revision), minimally 2 years up to 16 years (2007-2023)
Time from primary hip surgery to implant failure, per hip stem length
次要结局
- NRS pain score(before surgery, 3-6 months after surgery, 12 months after surgery)
- EQ - 5D(before surgery, 3-6 months after surgery, 12 months after surgery)
- Revision rate(From date of surgery to date of event (death), minimally 2 years up to 16 years (2007-2023))
- Oxford hip score(before surgery, 3-6 months after surgery, 12 months after surgery)
- HOOS - PS(before surgery, 3-6 months after surgery, 12 months after surgery)
- Mortality rate(From date of surgery to date of event (revision), minimally 2 years up to 16 years (2007-2023))