A Randomized Controlled Trial Comparing Reoperation Rates and Clinical Outcomes of Rotating Hinge Versus Condylar Constrained Knee Implants in Revision Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 186
- 试验地点
- 2
- 主要终点
- Reoperation Rate
研究概览
简要总结
The primary purpose of this study is to compare reoperation rates for rotating hinge knee implants versus condylar constrained knee implants when used in revision total knee arthroplasty. The secondary purposes are to compare patient satisfaction, loosening rates and clinical outcomes for RHK implants compared to CCK implants in rTKA. Additionally, knee range of motion and stability will be assessed and compared at all follow-up time points. We hypothesize that RHK implants provide patients undergoing rTKA with similar reoperation rates to those of patients who receive a CCK implant. The investigators hypothesize that patients who receive an RHK implant will have similar loosening rates and clinical outcomes compared to patients who receive a CCK implant. Lastly, knee stability and patient satisfaction may improve with the use of a rotating hinge device.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing a revision total knee arthroplasty for any etiology
- •Requires revision of both tibial and femoral components
排除标准
- •Undergoing primary total knee arthroplasty
- •Candidate for only rotating hinge knee implant
- •Diagnosed with active infection
- •Does not meet age criteria of >18 or <80
- •Pregnant or breastfeeding
- •Unable to consent
- •Non-independent dweller (prisoner)
研究组 & 干预措施
Condylar Constrained Knee
Patients in this arm will receive a condylar constrained implant.
干预措施: Condylar Constrained knee system. ( NexGen Legacy Condylar Constrained Knee by Zimmer Biomet) (Device)
Rotating Hinge Knee
Patients in this arm will receive a rotating hinge knee implant.
干预措施: Rotating Hinge Knee ( NexGen Rotating Hinge Knee by Zimmer Biomet) (Device)
结局指标
主要结局
Reoperation Rate
时间窗: From time of surgery to end of study. Investigators will plan to assess for reoperation at routine standard of care visits at the following time points: 6 weeks postoperatively, 6 months, 1 year, and then annually for 8 years
The primary outcome is any reoperation on the ipsilateral knee.
次要结局
- KOOS JR score(From time of surgery to end of study. Investigators will obtain patient reported outcomes at routine standard of care visits at the following time points: preop visit and then 6 weeks postoperatively, 6 months, 1 year, and then annually for 8 years.)
- Aseptic Loosening(Investigators will plan to assess for Aseptic loosening at routine standard of care visits at the following time points: 6 weeks postoperatively, 6 months, 1 year, and then yearly thereafter for 8 years through radiographs)
- Range of motion(Investigators will plan to assess range of motion at routine standard of care clinic visits at the following time points: 6 weeks postoperatively, 6 months, 1 year, and then yearly after for 8 years)
- Knee society score (KSS)(From time of surgery to end of study. Investigators will plan to assess for PROMs at routine standard of care visits at the following time points: pre-op visit, 6 weeks postoperatively, 6 months, 1 year, and then annually for 8 years)
- PROMIS score(From time of surgery to end of study. Investigators will obtain patient reported outcomes at routine standard of care visits at the following time points: preop visit and then 6 weeks postoperatively, 6 months, 1 year, and then annually for 8 years.)
- UCLA Activity Score(From time of surgery to end of study. Investigators will obtain patient reported outcomes at routine standard of care visits at the following time points: preop visit and then 6 weeks postoperatively, 6 months, 1 year, and then annually for 8 years.)
- EQ5D score(From time of surgery to end of study. Investigators will obtain patient reported outcomes at routine standard of care visits at the following time points: preop visit and then 6 weeks postoperatively, 6 months, 1 year, and then annually for 8 years.)
- SANE score(From time of surgery to end of study. Investigators will obtain patient reported outcomes at routine standard of care visits at the following time points: preop visit and then 6 weeks postoperatively, 6 months, 1 year, and then annually for 8 years.)
- Radiographic assessment of fixation(From time of surgery to end of study. Investigators will plan to assess for fixation at routine standard of care visits at the following time points: 6 weeks postoperatively, 6 months, 1 year, and then annually for 8 years.)