Diagnostic Accuracy of Dual-energy CT (DAD)

Diagnostic Value of Dual-energy CT to Detect and Characterize Crystal Deposits in Patients With Hand Osteoarthritis Undergoing Hand Surgery: a Diagnostic Accuracy Study

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Hand Osteoarthritis; Crystal; Deposit Joint; Crystals; Arthritis, Pyrophosphate; Crystals; Arthritis, Hydroxyapatite; Crystal Arthritis; Crystal Arthropathy of Hand
• Intervention / Treatment: Radiation: CT-scanning

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Denmark
  • DK
    • Copenhagen, DK, Denmark, 2000
      • The Parker Institute, Bispebjerg and Frederiksberg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with hand OA awaiting hand surgery of a joint with OA will be considered eligible.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive likelihood ratio	To determine the positive likelihood ratio of DECT to detect crystal deposition in an osteoarthritic joint of the hand.	20 months
Discriminating joint-associated crystals	To determine DECTs ability to discriminate MSU from calcium-containing crystals in an osteoarthritic joint of the hand.	20 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Negative likelihood ratio	To determine the negative likelihood ratio of DECT to detect crystal deposition in an osteoarthritic joint of the hand.	20 months
Inflammation	Synovitis-score of inflammation detected by ultrasound	20 months
Relationship between inflammation and crystals	Analysis of covariance (ANCOVA), with a factor for presence of crystals (X=1 or X=0), and synovitis score as dependent variable.	20 months
Degenerative status	Described by KL-score	20 months
Relationship between KL-score and crystals	Analysis of covariance (ANCOVA), with a factor for presence of crystals (X=1 or X=0), and KL-score as dependent variable.	20 months
Erosions score	Erosions as estimated by the hand osteoarthritis magnetic resonance imaging scoring system (HOAMRIS) for erosions evaluated by CBCT	20 months
Relationship between erosion-score and crystals	Analysis of covariance (ANCOVA), with a factor for presence of crystals (X=1 or X=0), and erosion-score as dependent variable.	20 months

Collaborators and Investigators

• Sponsor: Henning Bliddal
• Investigators: Principal Investigator: Henning Bliddal, MD, DMSc, Parker Instituttet

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): August 25, 2022
• Study Completion (Actual): August 25, 2022

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: October 7, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): October 24, 2022
• Last Update Submitted That Met QC Criteria: October 21, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Crystal Arthropathies
• Other Study ID Numbers: DAD2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No