Diagnostic Accuracy of Dual-energy CT

Study Overview
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Brief Summary
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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.

Official Title
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Diagnostic Value of Dual-energy CT to Detect and Characterize Crystal Deposits in Patients With Hand Osteoarthritis Undergoing Hand Surgery: a Diagnostic Accuracy Study

Conditions
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Osteoarthritis, Hand Osteoarthritis, Crystal; Deposit Joint, Crystals; Arthritis, Pyrophosphate, Crystals; Arthritis, Hydroxyapatite, Crystal Arthritis, Crystal Arthropathy of Hand

Intervention / Treatment
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* Radiation: CT-scanning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| People with hand OA awaiting surgery<br>Patients with hand OA awaiting hand surgery of a joint with OA will be considered eligible. All IP joints in the hands are eligible (thus both IP, PIP and DIP) if in- and exclusion criteria are fulfilled. | Radiation: CT-scanning<br>* All participants will receive dual-energy CT scanning and cone-beam CT scanning prior surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive likelihood ratio | To determine the positive likelihood ratio of DECT to detect crystal deposition in an osteoarthritic joint of the hand. | 20 months | 
| Discriminating joint-associated crystals | To determine DECTs ability to discriminate MSU from calcium-containing crystals in an osteoarthritic joint of the hand. | 20 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative likelihood ratio | To determine the negative likelihood ratio of DECT to detect crystal deposition in an osteoarthritic joint of the hand. | 20 months | 
| Inflammation | Synovitis-score of inflammation detected by ultrasound | 20 months | 
| Relationship between inflammation and crystals | Analysis of covariance (ANCOVA), with a factor for presence of crystals (X=1 or X=0), and synovitis score as dependent variable. | 20 months | 
| Degenerative status | Described by KL-score | 20 months | 
| Relationship between KL-score and crystals | Analysis of covariance (ANCOVA), with a factor for presence of crystals (X=1 or X=0), and KL-score as dependent variable. | 20 months | 
| Erosions score | Erosions as estimated by the hand osteoarthritis magnetic resonance imaging scoring system (HOAMRIS) for erosions evaluated by CBCT | 20 months | 
| Relationship between erosion-score and crystals | Analysis of covariance (ANCOVA), with a factor for presence of crystals (X=1 or X=0), and erosion-score as dependent variable. | 20 months |