Intra-articular Volumetric Assessment After Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Participants with total knee arthroplasty assessed for intra-articular hematoma
研究概览
简要总结
The purpose of the study: is to quantify the amount of post-operative effusion or hematoma present after total knee arthroplasty pre-operatively, post-operative day #0,1.
Patients undergoing a total knee arthroplasty will undergo an MRI on the operative knee at the following times:
- Pre-operatively
- Post-operative day #1 (approximately 16-20 hours post op)
- Post-operative day #2 (approximately 36-40 hours post op) This will be conducted by the Loma Linda radiology department as per normal protocols. No special imaging procedures will be undertaken.
Subjects will be both male and females, they will be patients from the Principle Investigator and Co-Investigators practice. Subjects will be between the ages of 18-89 years of age.
The total participation will last approximately 30 days.
Subject selection will be approximately 10 English speaking, both male and female between the ages of 18 to 89 years of age. Subjects will be recruited from the Principal Investigators and Co-Investigators clinic. There will be no advertising or electronic recruiting. The study is expected to last 12 months.
详细描述
STUDY DESIGN:
Background or rationale for this study:
Total knee arthroplasty is one of the most successful orthopedic surgeries performed in the United States, and consistently has shown to have excellent outcomes for patients, with low complication rates. However, when complications do happen, they can range from superficial infection to repeated deep infection requiring prosthesis exchange or amputation. Another significant complication of total knee arthroplasty is joint stiffness. Range of motion loss can also be an extremely debilitating complication necessitating prolonged physical therapy, return to the operating theater for manipulation or even total synovectomy and polyethylene exchange.
Although it is currently known that post-operative hematoma leads to adverse outcomes following total knee arthroplasty, there is currently no literature to quantify the average size or progression of the intra-articular bleeding post operatively. It would be reasonable to assume that all patients develop a slight hematoma post operatively. The investigator aims to assess the size, and possible progression of the intra-articular hematoma following total knee arthroplasty.
OBJECTIVES:
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective primary total knee arthroplasty.
- •Patients not meeting exclusion criteria
排除标准
- •If patient is not able to undergo MRI
- •Heart pacemaker
- •Cochlear implant
- •Metallic foreign body (metal silver) in the eyes
- •Aneurysm clip in the brain
- •Patient with prior reaction or contra-indication to tranexamic acid
- •Inability to comprehend consent process
- •Age <18 or > 89
- •Patient planned for outpatient procedure
- •Active malignancy
- •Patients with hematologic disorders (hemophilia, factor V Leiden, etc.)
- •Patients with any condition that makes undergoing a MRI painful (severe spine degenerative disease, vertigo, etc.)
结局指标
主要结局
Participants with total knee arthroplasty assessed for intra-articular hematoma
时间窗: 30 days
MRI studies will be reviewed on these participants pre-operatively and postoperatively. Data will be analyzed using the Statistical package for social sciences (SPSS) software and paired T-Test will be utilized for significance regarding the effusion post operatively.
次要结局
未报告次要终点
研究者
Nirav Amin, MD
Associate Professor
Loma Linda University