Diagnostic Accuracy of Dual-energy CT (DAD)
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|ClinicalTrials.gov Identifier: NCT04585113|
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : October 14, 2020
|Condition or disease||Intervention/treatment|
|Osteoarthritis Hand Osteoarthritis Crystal; Deposit Joint Crystals; Arthritis, Pyrophosphate Crystals; Arthritis, Hydroxyapatite Crystal Arthritis Crystal Arthropathy of Hand||Radiation: CT-scanning|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Diagnostic Value of Dual-energy CT to Detect and Characterize Crystal Deposits in Patients With Hand Osteoarthritis Undergoing Hand Surgery: a Diagnostic Accuracy Study|
|Estimated Study Start Date :||October 2020|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||May 2022|
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.
All participants will receive dual-energy CT scanning and cone-beam CT scanning prior surgery.
- Positive likelihood ratio [ Time Frame: 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 [ Time Frame: 20 months ]To determine DECTs ability to discriminate MSU from calcium-containing crystals in an osteoarthritic joint of the hand.
- Negative likelihood ratio [ Time Frame: 20 months ]To determine the negative likelihood ratio of DECT to detect crystal deposition in an osteoarthritic joint of the hand.
- Inflammation [ Time Frame: 20 months ]Synovitis-score of inflammation detected by ultrasound
- Relationship between inflammation and crystals [ 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.
- Degenerative status [ Time Frame: 20 months ]Described by KL-score
- Relationship between KL-score and crystals [ 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.
- Erosions score [ Time Frame: 20 months ]Erosions as estimated by the hand osteoarthritis magnetic resonance imaging scoring system (HOAMRIS) for erosions evaluated by CBCT
- Relationship between erosion-score and crystals [ 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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04585113
|Contact: Anna Døssing, MD||+45 firstname.lastname@example.org|
|The Parker Institute, Bispebjerg and Frederiksberg Hospital||Recruiting|
|Copenhagen, DK, Denmark, 2000|
|Contact: Anna Døssing, MD 38164153 email@example.com|
|Principal Investigator:||Henning Bliddal, MD, DMSc||Parker Instituttet|