Analysis of Metal Ion Concentrations After Robotic-assisted Total Knee Arthroplasty Compared to Conventional Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall blood metal ion differences between procedures (Conventional TKA vs Robot-Assisted TKA)
研究概览
简要总结
The purpose of this study is to analyze the metal ion concentrations in the patients blood following robotic-assisted total knee arthroplasty (TKA) compared to conventional total knee arthroplasty using cutting guides.
详细描述
This study focuses on comparing metal ion levels in 50 inpatient participants undergoing primary total knee arthroplasty (TKA) with either conventional cutting guides or robotic assistance. Baseline blood examinations for Cobalt, Chromium, Titanium, and Nickel will be performed before TKA implantation at preoperative visits and on the first day following the procedure. The investigation will encompass patients receiving both conventional and robotic-assisted primary TKA, framed within a prospective cohort study design. Baseline characteristics and additional follow-up information will be gathered.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults undergoing conventional or robotic-assisted TKA
- •Consent to the study
排除标准
- •Patients who have undergone any previous arthroplasty procedures.
- •Patients with metal implants, such as plates, nails, and screws, used in the repair of traumatic injuries.
- •Patients below 110 pounds.
研究组 & 干预措施
Conventional TKA with Cutting Guides
Patients undergoing a conventional total knee arthroplasty with cutting guides (no robot-assistance).
干预措施: Metal ion level testing (Other)
Robot-Assisted TKA
Patients undergoing a robot-assisted total knee arthroplasty.
干预措施: Metal ion level testing (Other)
结局指标
主要结局
Overall blood metal ion differences between procedures (Conventional TKA vs Robot-Assisted TKA)
时间窗: Pre-operatively, first post-operative day.
Difference in overall blood metal ion levels (Cobalt, Chromium, Titanium, and Nickel) between patients undergoing total knee arthroplasty (TKA) with conventional cutting guides and those undergoing TKA with robotic assistance.
次要结局
- Comparison of post-operative blood metal levels between procedures: Cobalt(First post-operative day)
- Comparison of post-operative blood metal levels between procedures: Chromium(First post-operative day)
- Comparison of post-operative blood metal levels between procedures: Titanium(First post-operative day)
- Comparison of post-operative blood metal levels between procedures: Nickel(First post-operative day)
研究者
Matthew P. Abdel, M.D.
Principal Investigator
Mayo Clinic