Diagnostic Value of Dual-energy CT to Detect and Characterize Crystal Deposits in Patients With Hand Osteoarthritis Undergoing Hand Surgery: a Diagnostic Accuracy Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Positive likelihood ratio
研究概览
简要总结
The study will include 20 people with hand OA awaiting surgery in the fingers. Participants will undergo dual-energy CT, cone-beam CT, ultrasound, clinical examination, blood sampling and questionnaires. Images will be analysed for the presence of joint-associated crystal including monosodium urate, calcium pyrophosphate and calcium hydroxyapatite. Material obtained during surgery will be used for crystal verification and calculation of diagnostic accuracy of dual-energy CT and cone-beam CT.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Informed consent obtained.
- •Patients with hand OA as defined by the American College of Rheumatology Classification Criteria for hand OA:
- •Hand pain, aching or stiffness
- •And 3 or 4 of the following features:
- •Hard tissue enlargement of ≥2 of the 10 selected joints*.
- •Hard tissue enlargement of ≥2 of the 10 DIP joints.
- •Fewer than 3 swollen MCP joints.
- •Deformity of at least 1 of 10 selected joints*. *The 10 selected joints are the second and third DIP, the second and third PIP, and the first carpometacarpal joints of both hands.
排除标准
- •Known inflammatory rheumatic diseases (e.g. rheumatoid arthritis, gout, psoriatic arthritis, psoriasis, inflammatory bowel disease), or other joint diseases (haemochromatosis)
- •Positive anti-cyclic citrullinated peptide (>10 kU/L)
- •Known cutaneous deposition diseases (e.g. amyloidosis or porphyria).
- •Foreign material/metallic implants at the area of interest will be excluded to avoid artefacts on CBCT [68].
- •Other diseases in the area - e.g. skin disease, known previous fracture in the joint of interest.
- •Participation in experimental device or experimental drug study 3 months prior to enrolment.
- •Pregnancy or breast-feeding.
- •Previous septic arthritis at the target joint.
- •Previous surgical procedures at the target joint.
- •Injection into the target joint within 3 months prior to enrolment.
- •Inability to speak and read Danish fluently.
- •Treatment with Colchicine within the last 30 days.
- •Treatment with systemic steroids ≥7.5 mg prednisolone within the last 30 days.
- •Lack of sample obtained for reference standard, i.e. unable to obtain either synovial fluid, joint lavage fluid, joint biopsy or excite joint.
- •Any other condition that in the opinion of the investigator may interfere with study participation.
- •There will be no restriction on sex or Kellgren-Lawrence (KL) grading.
结局指标
主要结局
Positive likelihood ratio
时间窗: 20 months
To determine the positive likelihood ratio of DECT to detect crystal deposition in an osteoarthritic joint of the hand.
Discriminating joint-associated crystals
时间窗: 20 months
To determine DECTs ability to discriminate MSU from calcium-containing crystals in an osteoarthritic joint of the hand.
次要结局
- Inflammation(20 months)
- Negative likelihood ratio(20 months)
- Relationship between inflammation and crystals(20 months)
- Degenerative status(20 months)
- Relationship between KL-score and crystals(20 months)
- Erosions score(20 months)
- Relationship between erosion-score and crystals(20 months)
研究者
Henning Bliddal
MD, DMSci, Professor of Rheumatology
Frederiksberg University Hospital