Comparison of Weight Bearing CT Arthrography With MRI for Detection of Knee Meniscal and Cartilage Lesions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To determine the agreement between weight-bearing CT arthrography (WBCTa) and MRI in evaluation of meniscal tears.
研究概览
简要总结
This observational study will compare the clinical value of weight-bearing CT arthrography (WBCTa) with that for MRI in evaluating meniscal and cartilage lesions of the knee joint. The MRI Osteoarthritis Knee Score (MOAKS) and modified MOAKS for WBCTa will be used to compare findings between MRI and WBCTa of the knee while comparing with surgical measurements using the ICRS scoring system.
The study hypothesis is that meniscal and cartilage lesions may be missed by non-weight-bearing MRI, but detected by WBCTa.
详细描述
Study Objectives:
Aim 1 Establish the accuracy of WBCTa and MRI for diagnosing knee cartilage and meniscal lesions in both surgical and non-surgical participants.
Hypothesis 1: Pre-operative cartilage and meniscal scoring on WBCTa is more accurate than MRI, in comparison with arthroscopic assessment.
Aim 2 Establish the accuracy of WBCTa for detecting persistent and recurrent meniscal root and radial tears not detected by MRI 6 months after meniscal repair (defined by diastasis of the repair or meniscal extrusion ≥3mm).
Hypothesis 2: Six months following meniscal repair, WBCTa detects persistent and recurrent meniscal root and radial re-tears not detected by MRI.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female over 18 years of age with a knee MRI acquired in the previous 10 days to evaluate for suspected meniscal or cartilage pathology.
- •Body mass index (BMI) ≤ 45 kg/m2
- •Ability to stand with support without moving for at least 2 minutes.
排除标准
- •End stage kidney disease
- •Allergic to iodinated contrast material.
- •Pregnancy
- •Skin breakdown or rash at the knee joint which would prevent injection of the contrast.
- •Any clinically significant degree of cognitive impairment or other condition, finding, or psychiatric illness at screening which, in the opinion of the investigator, affects their ability to ambulate to a sufficient degree and could compromise patient safety or interfere with the assessment of the safety of the study injection.
- •Superficial or deep infection in or around the index knee joint or allergy to iodinated contrast media.
- •History of inflammatory arthritis, meniscectomy, or end-stage OA
结局指标
主要结局
To determine the agreement between weight-bearing CT arthrography (WBCTa) and MRI in evaluation of meniscal tears.
时间窗: Baseline
Pre-operative cartilage lesion scoring of meniscal lesions on WBCTa (modified MOAKS score) and MRI (modified MOAKS score) will be compared with arthroscopic visual MOAKS scoring of meniscal lesions.
次要结局
- To determine the extent to which WBCTa identifies meniscal re-tears or failed repairs 6 months following meniscal root or radial tear surgical repairs(6 months)
- To determine the agreement between weight-bearing CT arthrography and MRI in evaluation of cartilage lesions.(Baseline)
研究者
Neil Segal, MD, MS
Director of Clinical Research
University of Kansas Medical Center