Diagnostic Accuracy of Dual-energy CT

Osteoarthritis Clinical Trial

— DAD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04585113
• Other study ID #: DAD2020
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: August 25, 2022

Study information

• Verified date: October 2022
• Source: Frederiksberg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 25, 2022
• Est. primary completion date: August 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Crystal Arthritis
• Crystal Arthropathy of Hand
• Crystal; Deposit Joint
• Crystals; Arthritis, Hydroxyapatite
• Crystals; Arthritis, Pyrophosphate
• Hand Osteoarthritis
• Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
Denmark	The Parker Institute, Bispebjerg and Frederiksberg Hospital	Copenhagen	DK

Sponsors (1)

Lead Sponsor	Collaborator
Henning Bliddal

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive likelihood ratio	To determine the positive likelihood ratio of DECT to detect crystal deposition in an osteoarthritic joint of the hand.	20 months
Primary	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	Negative likelihood ratio	To determine the negative likelihood ratio of DECT to detect crystal deposition in an osteoarthritic joint of the hand.	20 months
Secondary	Inflammation	Synovitis-score of inflammation detected by ultrasound	20 months
Secondary	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
Secondary	Degenerative status	Described by KL-score	20 months
Secondary	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
Secondary	Erosions score	Erosions as estimated by the hand osteoarthritis magnetic resonance imaging scoring system (HOAMRIS) for erosions evaluated by CBCT	20 months
Secondary	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