Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
12 participants
OBSERVATIONAL
2020-10-01
2022-08-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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People with hand OA awaiting surgery
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.
CT-scanning
All participants will receive dual-energy CT scanning and cone-beam CT scanning prior surgery.
Interventions
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CT-scanning
All participants will receive dual-energy CT scanning and cone-beam CT scanning prior surgery.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Henning Bliddal
OTHER
Responsible Party
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Henning Bliddal
MD, DMSci, Professor of Rheumatology
Principal Investigators
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Henning Bliddal, MD, DMSc
Role: PRINCIPAL_INVESTIGATOR
Parker Instituttet
Locations
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The Parker Institute, Bispebjerg and Frederiksberg Hospital
Copenhagen, DK, Denmark
Countries
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Other Identifiers
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DAD2020
Identifier Type: -
Identifier Source: org_study_id
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