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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 : August 18, 2021
Sponsor:
Information provided by (Responsible Party):
Henning Bliddal, Frederiksberg University Hospital

Study Description
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Brief Summary:
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.

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 Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Other
Time Perspective: Cross-Sectional
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
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Radiation: CT-scanning
All participants will receive dual-energy CT scanning and cone-beam CT scanning prior surgery.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. Inflammation [ Time Frame: 20 months ]
    Synovitis-score of inflammation detected by ultrasound

  3. 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.

  4. Degenerative status [ Time Frame: 20 months ]
    Described by KL-score

  5. 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.

  6. Erosions score [ Time Frame: 20 months ]
    Erosions as estimated by the hand osteoarthritis magnetic resonance imaging scoring system (HOAMRIS) for erosions evaluated by CBCT

  7. 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
Material obtained during surgery from the joint.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with hand OA awaiting hand surgery of a joint with OA will be considered eligible.
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.

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Anna Døssing, MD +45 38164153 anna.dossing@gmail.com

Locations
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Denmark
The Parker Institute, Bispebjerg and Frederiksberg Hospital Recruiting
Copenhagen, DK, Denmark, 2000
Contact: Anna Døssing, MD    38164153    anna.dossing@gmail.com   
Sponsors and Collaborators
Henning Bliddal
Investigators
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Principal Investigator: Henning Bliddal, MD, DMSc Parker Instituttet
More Information
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Responsible Party: Henning Bliddal, MD, DMSci, Professor of Rheumatology, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT04585113    
Other Study ID Numbers: DAD2020
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: August 18, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Crystal Arthropathies
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases