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OpenTrials
Completed

NCT Number: NCT04585113

Diagnostic Accuracy of Dual-energy CT

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Parker Institute, Bispebjerg and Frederiksberg Hospital

Copenhagen, DK, 2000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years.
  • Informed consent obtained.
  • 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

  • Known inflammatory rheumatic diseases (e.g. rheumatoid arthritis, gout, psoriatic arthritis, psoriasis, inflammatory bowel disease), or other joint diseases (haemochromatosis)
  • Positive anti-cyclic citrullinated peptide (>10 kU/L)
  • Known cutaneous deposition diseases (e.g. amyloidosis or porphyria).
  • Foreign material/metallic implants at the area of interest will be excluded to avoid artefacts on CBCT [68].
  • Other diseases in the area - e.g. skin disease, known previous fracture in the joint of interest.
  • Participation in experimental device or experimental drug study 3 months prior to enrolment.
  • Pregnancy or breast-feeding.
  • Previous septic arthritis at the target joint.
  • Previous surgical procedures at the target joint.
  • Injection into the target joint within 3 months prior to enrolment.
  • Inability to speak and read Danish fluently.
  • Treatment with Colchicine within the last 30 days.
  • Treatment with systemic steroids ≥7.5 mg prednisolone within the last 30 days.
  • Lack of sample obtained for reference standard, i.e. unable to obtain either synovial fluid, joint lavage fluid, joint biopsy or excite joint.
  • 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.

Treatment and study plan

CT-scanning

Radiation

All participants will receive dual-energy CT scanning and cone-beam CT scanning prior surgery.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Henning Bliddal

Other

Registry information

Official study 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

Acronym: DAD

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 14, 2020
Registry last updated
Oct 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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