Association Between Preoperative Clinical Evaluation, Radiological Classifications and Histopathology in Patients With Knee Osteoarthritis Receiving a Prosthesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 主要终点
- Radiographic assesment of osteoarthritis according to absence/presence of pathology
研究概览
简要总结
Patients with osteoarthritis of the knee undergo visible joint changes in radiology and Magnetic resonance imaging (MRI) tests, but also clinically and histologically. The area of greatest change is at the subchondral/cartilage bone junction.
Investigators will determine the association between preoperative clinical evaluation (IKDC and Womac scores), radiological classifications and histopathology.
In addition, the role of inflammation in the pathogenesis of osteoarthritis is being given major interest, and inflammation is closely linked with vascularization. It was recently demonstrated that dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) could identify the subchondral bone marrow vascularization changes occurring in osteoarthritis in animals.
These changes appeared before cartilage lesions were visible and were correlated with osteoarthritis severity. Thus the opportunity to obtain an objective assessment of bone vascularization in non-invasive conditions in humans might help better understanding osteoarthritis pathophysiology and finding new biomarkers. Investigators hypothesized that, as in animals, DCE-MRI has the ability to identify subchondral bone marrow vascularization changes in human osteoarthritis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with knee osteoarthritis, classified Kellgren-Lawrence 3 or 4, with asymmetric femorotibial joint space narrowing
- •Patients requiring a total knee prosthesis
排除标准
- •Patients with a known progressive inflammatory pathology (rheumatoid arthritis,...).
- •Patients with previous surgery of the knee
- •Contra-indication for magnetic resonance imaging, chronic renal failure (creatinine clearance < 30 ml/min), contrast media allergy, orthopaedic hardware around the knee. Patients in whom motion artifacts impaired image analysis will be excluded.
结局指标
主要结局
Radiographic assesment of osteoarthritis according to absence/presence of pathology
时间窗: At inclusion
Assesment of subchondral bone marrow vascularization by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) according to the % Area Under the Curve (AUC) of perfusion value
时间窗: At inclusion
Analysis of the surgical section by the OARSI score (Osteoarthritis research society international) for evaluation of histologic status
时间窗: through study completion, an average of 3 years
The OARSI system is based on histologic features of osteoarthritis progression. The system employs analysis of a standard block/section assessment by grade, stage of arthritis with subsequent calculation of an arthritis score. With normal cartilage as grade 0, osteoarthritis severity is divided into six grades. Grades 1-4 involve articular cartilage changes only, whereas grades 5 and 6 involve subchondral bone as well.
Score IKDC (International Knee Documentation Committee) for functional evaluation of the articulation
时间窗: At inclusion
The IKDC Questionnaire is a subjective scale that provides patients with an overall function score. The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. The symptoms subscale helps to evaluate things such as pain, stiffness, swelling and giving-way of the knee. Meanwhile, the sports activity subscale focuses on functions like going up and down the stairs, rising from a chair, squatting and jumping. The knee function subscale asks patients one simple question: how is their knee at present versus how was their knee prior to injury? Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.
The magnetic resonance imaging -based Whole-Organ Magnetic Resonance Imaging (WORMS) Score to assess the full spectrum of knee structures and the severity of knee pathologies
时间窗: At inclusion
WORMS scoring for cartilage. Cartilage lesions are scored with the WORMS system on an eight-point scale, as follows: 0 indicates normal cartilage; 1, increased signal with fluid-sensitive intermediate-weighted sequences; 2, partial-thickness defect less than 1 cm in greatest width; 2.5, full-thickness defect less than 1 cm in greatest width; 3, multiple areas of partial-thickness (grade 2) defects intermixed with areas of normal thickness or a partial-thickness defect wider than 1 cm but less than 75% of the region; 4, diffuse (≥75% of the region) partial-thickness loss; 5, multiple areas of full-thickness loss (grade 2.5) or a full-thickness defect wider than 1 cm but less than 75% of the region; and 6, diffuse (≥75% of the region) full-thickness loss.
Osteoarthritis pathology assessment according to the thickness of the subchondral bone
时间窗: through study completion, an average of 3 years
Analysis of the surgical section
Score WOMAC (Western Ontario McMaster University ) for functional evaluation of the articulation
时间窗: At inclusion
An arthritic pain scoring system ranging from 0-no pain/disability to 100-most severe pain/disability
Osteoarthritis pathology assessment according to the number of vessels in the subchondral bone
时间窗: through study completion, an average of 3 years
Analysis of the surgical section
次要结局
未报告次要终点