The Parker Institute, Bispebjerg and Frederiksberg Hospital
Copenhagen, DK, 2000, Denmark
NCT Number: NCT04585113
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.
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Notify Me18 year and older
All sexes
Observational
Copenhagen, DK, 2000, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
And 3 or 4 of the following features:
Exclusion criteria
There will be no restriction on sex or Kellgren-Lawrence (KL) grading.
All participants will receive dual-energy CT scanning and cone-beam CT scanning prior surgery.
Time frame: 20 months
To determine the positive likelihood ratio of DECT to detect crystal deposition in an osteoarthritic joint of the hand.
Time frame: 20 months
To determine DECTs ability to discriminate MSU from calcium-containing crystals in an osteoarthritic joint of the hand.
Time frame: 20 months
To determine the negative likelihood ratio of DECT to detect crystal deposition in an osteoarthritic joint of the hand.
Time frame: 20 months
Synovitis-score of inflammation detected by ultrasound
Time frame: 20 months
Analysis of covariance (ANCOVA), with a factor for presence of crystals (X=1 or X=0), and synovitis score as dependent variable.
Time frame: 20 months
Described by KL-score
Time frame: 20 months
Analysis of covariance (ANCOVA), with a factor for presence of crystals (X=1 or X=0), and KL-score as dependent variable.
Time frame: 20 months
Erosions as estimated by the hand osteoarthritis magnetic resonance imaging scoring system (HOAMRIS) for erosions evaluated by CBCT
Time frame: 20 months
Analysis of covariance (ANCOVA), with a factor for presence of crystals (X=1 or X=0), and erosion-score as dependent variable.
Henning Bliddal
Other
Diagnostic Value of Dual-energy CT to Detect and Characterize Crystal Deposits in Patients With Hand Osteoarthritis Undergoing Hand Surgery: a Diagnostic Accuracy Study
Acronym: DAD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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