Diagnostic Accuracy of Dual-energy CT

NCT04585113 | Completed

• 1 other identifier: DAD2020
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Negative likelihood ratio

  20 months

• Inflammation

  20 months

• Relationship between inflammation and crystals

  20 months

• Degenerative status

  20 months

• Relationship between KL-score and crystals

  20 months

Study Arms (1)

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

Interventions

CT-scanning RADIATION

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

People with hand OA awaiting surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henning Bliddal: lead

Study Sites (1)

The Parker Institute, Bispebjerg and Frederiksberg Hospital

Copenhagen, DK, 2000, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Material obtained during surgery from the joint.

MeSH Terms

Conditions

Osteoarthritis; Arthritis; Crystal Arthropathies

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Henning Bliddal, MD, DMSc

  Parker Instituttet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, DMSci, Professor of Rheumatology

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 14, 2020
• Study Start: October 1, 2020
• Primary Completion: August 25, 2022
• Study Completion: August 25, 2022
• Last Updated: October 24, 2022

Record last verified: 2022-10

Locations

DK (1)