Native Alignment in the Setting of an Arthritic Knee in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Overall Satisfaction
研究概览
简要总结
The goal of this clinical trial is to learn if preparing the target alignment of the operative side in total knee arthroplasty (TKA) based on the non-arthritic side will give the patient better overall alignment, function, and improved results compared to basing our implant alignment and positioning off the arthritic side, which is currently the traditional method.
The main questions it aims to answer are:
- Will a patient have improved postoperative TKA results if the implant alignment is based off the non-arthritic side compared to the standard arthritic side?
- What are the similarities or differences between study arms with respect to final implant alignment and positioning angles? Researchers will compare the outcomes of two cohorts of patients undergoing primary robotic-assisted total knee arthroplasty (RA-TKA) with normal contralateral knee. Based on preoperative CT imaging, the researchers will use normal contralateral side joint numbers as the target alignment for one group (Experimental arm) and utilize the traditional method for the other group (Active comparator arm). Clinical outcomes and patient-reported outcome measures (PROMs) will be compared between groups.
Participants will:
- Be randomized into one of two study arms and will receive either a unilateral knee CT or bilateral knee CT preoperatively
- Follow-up in the clinic at 2 weeks, 6 weeks and 1-year postoperatively, per standard-of-care for x-ray and clinical evaluation.
- Complete postop questionnaires (PROMs) at the prescribed follow-up intervals
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age is 21-89 at time of surgery
- •Patient is indicated to undergo a unilateral primary TKA, secondary to osteoarthritis
- •Patient's contralateral knee is non-arthritic
- •Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document
- •Patient is able to read and speak English.
排除标准
- •Patient is under the age of 21
- •Patient's primary diagnosis is not osteoarthritis
- •Patient is unable to read and speak English
- •History of previous DVT/PE
- •History of stroke, CABG, or A fib
- •Current smoker
研究组 & 干预措施
Participant receives bilateral knee CT preoperatively
The P.I. (Dr. Malkani) will use normal contralateral side joint numbers as the target alignment for RA-TKA
干预措施: CT scan bilateral knee (Diagnostic Test)
Participant receives unilateral CT of the operative knee preoperatively
The P.I. will use the traditional method to obtain target alignment for RA-TKA.
干预措施: CT scan unilateral knee (Diagnostic Test)
结局指标
主要结局
Overall Satisfaction
时间窗: 1-year postoperatively
Overall Satisfaction with TKA using a Likert scale
Pain VAS
时间窗: preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively
Level of knee pain (scale of zero to ten) using the Visual Analog Scale (VAS)
KOOS JR
时间窗: preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively
KOOS JR questionnaire
Forgotten Joint Score
时间窗: preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively
FJS-12 questionnaire
PROMIS-10 Mental and Physical Health scores
时间窗: preoperatively and 1-year postoperatively
PROMIS-10 Global Health questionnaire
Incidence of revision TKA
时间窗: 1 year postop
postoperative complication requiring a revision total knee arthroplasty
non-revision complication
时间窗: 1 year postop
postoperative complication requiring a non-revision procedure
次要结局
- Active ROM(preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively)
研究者
Arthur Malkani
Orthopedic Surgeon
University of Louisville