Diagnostic Accuracy of Dual-energy CT (DAD)

October 21, 2022 updated by: Henning Bliddal

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
20 months
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.
20 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
20 months
Inflammation
Time Frame: 20 months
Synovitis-score of inflammation detected by ultrasound
20 months
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.
20 months
Degenerative status
Time Frame: 20 months
Described by KL-score
20 months
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.
20 months
Erosions score
Time Frame: 20 months
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
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.
20 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Henning Bliddal

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Henning Bliddal, MD, DMSc, Parker Instituttet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 25, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 24, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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