OsteoarthritisDADNCT04585113
Diagnostic Accuracy of Dual-energy CT
An observational study of Osteoarthritis and Hand Osteoarthritis, run by Henning Bliddal at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Hand Osteoarthritis, Crystal; Deposit Joint
- What is being tested?
- CT-scanning
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2020to 25 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hand OA awaiting hand surgery of a joint with OA will be considered eligible.
Who may be able to join
- 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*.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Parker Institute, Bispebjerg and Frederiksberg Hospital
Copenhagen, DK, 2000
About this study
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
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
- Being tested
- CT-scanning
- Medical subject headings
- Osteoarthritis, Arthritis, Crystal Arthropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-scanningRadiation
All participants will receive dual-energy CT scanning and cone-beam CT scanning prior surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: CT-scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive likelihood ratio
To determine the positive likelihood ratio of DECT to detect crystal deposition in an osteoarthritic joint of the hand.
Measured: 20 months
Discriminating joint-associated crystals
To determine DECTs ability to discriminate MSU from calcium-containing crystals in an osteoarthritic joint of the hand.
Measured: 20 months
Secondary outcomes (7)
Negative likelihood ratio
To determine the negative likelihood ratio of DECT to detect crystal deposition in an osteoarthritic joint of the hand.
Measured: 20 months
Inflammation
Synovitis-score of inflammation detected by ultrasound
Measured: 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.
Measured: 20 months
Degenerative status
Described by KL-score
Measured: 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.
Measured: 20 months
Erosions score
Erosions as estimated by the hand osteoarthritis magnetic resonance imaging scoring system (HOAMRIS) for erosions evaluated by CBCT
Measured: 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.
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Oct 2020
- Primary completion25 Aug 2022
- Study completion25 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henning Bliddal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Henning Bliddal, Frederiksberg University Hospital
- Investigators
- Henning Bliddal, MD, DMSc, Principal investigator, Parker Instituttet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585113
- Sponsor's protocol ID
- DAD2020
- Acronym
- DAD
- Status last verified
- Oct 2022
- First submitted
- 30 Sep 2020
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dossing A, Stamp LK, Becce F, Muller CF, Bagge J, Hansen P, Manzano LG, McCarthy GM, Conaghan PG, Henriksen M, Christensen R, Terslev L, Ellegaard K, Nielsen NS, Juul L, Radev DI, Nybing JD, Bliddal H, Boesen M. Accuracy of dual-energy computed tomography (CT), ultrasound, cone-beam CT, and spectral photon-counting CT for detecting calcium crystal deposition in the osteoarthritic hand: a cross-sectional diagnostic test study. Scand J Rheumatol. 2026 Jul;55(4):264-275. doi: 10.1080/03009742.2026.2627069. Epub 2026 Mar 13.
PubMed 41823217
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04585113
- Acronym / sponsor ID
- DAD / DAD2020
- Conditions
- Osteoarthritis, Hand Osteoarthritis, Crystal; Deposit Joint, Crystals; Arthritis, Pyrophosphate, Crystals; Arthritis, Hydroxyapatite, Crystal Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Henning BliddalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 25 Aug 2022 (actual)
- Study completion
- 25 Aug 2022 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with hand OA awaiting surgery | – | Radiation: CT-scanningPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hand OA awaiting hand surgery of a joint with OA will be considered eligible.
Key inclusion criteria (9 listed)
- Age ≥ 18 years.
- Informed consent obtained.
- Patients with hand OA as defined by the American College of Rheumatology Classification Criteria for hand OA:
- Hard tissue enlargement of ≥2 of the 10 selected joints*.
- Hard tissue enlargement of ≥2 of the 10 DIP joints.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-scanningAll participants will receive dual-energy CT scanning and cone-beam CT scanning prior surgery. | Radiation | People with hand OA awaiting surgery |
Primary outcome
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.
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.
7 secondary outcomes
Negative likelihood ratio
Time frame: 20 months
Inflammation
Time frame: 20 months
Relationship between inflammation and crystals
Time frame: 20 months
Degenerative status
Time frame: 20 months
Relationship between KL-score and crystals
Time frame: 20 months
Erosions score
Time frame: 20 months
Relationship between erosion-score and crystals
Time frame: 20 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Derived from this study: PubMed 41823217Dossing A, Stamp LK, Becce F, Muller CF, Bagge J, Hansen P, Manzano LG, McCarthy GM, Conaghan PG, Henriksen M, Christensen R, Terslev L, Ellegaard K, Nielsen NS, Juul L, Radev DI, Nybing JD, Bliddal H, Boesen M. Accuracy of dual-energy computed tomography (CT), ultrasound, cone-beam CT, and spectral photon-counting CT for detecting calcium crystal deposition in the osteoarthritic hand: a cross-sectional diagnostic test study. Scand J Rheumatol. 2026 Jul;55(4):264-275. doi: 10.1080/03009742.2026.2627069. Epub 2026 Mar 13.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henning Bliddal, MD, DMSc principal investigator
Parker Instituttet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Hand Osteoarthritis, run by Henning Bliddal at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive likelihood ratio (time frame: 20 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04585113, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2022.