Clinical trial: Diagnostic Accuracy of Dual-energy CT (NCT04585113)

Eligibility criteria:
Inclusion Criteria:

          1. Age ≥ 18 years.

          2. Informed consent obtained.

          3. 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:

          1. Known inflammatory rheumatic diseases (e.g. rheumatoid arthritis, gout, psoriatic
             arthritis, psoriasis, inflammatory bowel disease), or other joint diseases
             (haemochromatosis)

          2. Positive anti-cyclic citrullinated peptide (>10 kU/L)

          3. Known cutaneous deposition diseases (e.g. amyloidosis or porphyria).

          4. Foreign material/metallic implants at the area of interest will be excluded to avoid
             artefacts on CBCT [68].

          5. Other diseases in the area - e.g. skin disease, known previous fracture in the joint
             of interest.

          6. Participation in experimental device or experimental drug study 3 months prior to
             enrolment.

          7. Pregnancy or breast-feeding.

          8. Previous septic arthritis at the target joint.

          9. Previous surgical procedures at the target joint.

         10. Injection into the target joint within 3 months prior to enrolment.

         11. Inability to speak and read Danish fluently.

         12. Treatment with Colchicine within the last 30 days.

         13. Treatment with systemic steroids ≥7.5 mg prednisolone within the last 30 days.

         14. Lack of sample obtained for reference standard, i.e. unable to obtain either synovial
             fluid, joint lavage fluid, joint biopsy or excite joint.

         15. 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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Entailment