Cone-beam vs Multidetector Computed Tomography (CT) for Arthrography of the Wrist, Ankle, Elbow and Knee (ARCOBE)

Study Description

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Brief Summary:

ConeBeam scanner (CBCT) is a widely technique used for dental and maxillofacial imaging. Patients can be set up in a sitting or a laying position in the, Newtom 5G CBCT allowing for an analysis of the limbs distal joints. Our hypothesis is that the cone-beam scanner could detect and characterize chondral lesions the cartilage similarly to a multidetector CT (MDCT). 100 patients over 18 years requiring arthroscanner of the wrist, ankle, elbow or knee will be enrolled The primary endpoint based on the ability of cone-beam scanner to detect cartilage lesions. Secondary endpoints will concern the depiction of the joint lesions, quality of the images, tolerability of the exams and inter- intra-operator reproducibility. After arthrography, patients will have a MDCT considered as the reference exam, and a CBCT on a randomized order. Exams will be anonymized and read twice by two trained radiologists with 3-6 week intervals. The inter-observer agreement for the diagnosis of cartilage lesion type between the two techniques will be evaluated by a kappa coefficient. The evaluation of diagnostic performance will be achieved by studying the sensitivity, specificity, negative predictive value and positive predictive value, and its likelihood ratio. Kappa test will be performed to evaluate the consistency of the depiction of the lesions. A Student t test will be performed for paired data if distributions are normal, a Wilcoxon test if not. To assess patient's tolerance, the percentages of (painful, not painful) will be calculated for each technique and will be compared using the Chi2 test (or Fisher's exact test if the chi can not apply).

Condition or disease	Intervention/treatment	Phase
Cartilage Ulceration of the Distal Joints	Device: CBCT prior to MDCT; Device: MDCT prior to CBCT	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	69 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	Performance of Cone-beam Computed Tomography (CT) Compared to Multidetector CT for Arthrography of the Wrist, Ankle, Elbow and Knee
Study Start Date :	July 2012
Actual Primary Completion Date :	June 2013
Actual Study Completion Date :	June 2013

Arms and Interventions

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Arm	Intervention/treatment
Experimental: CBCT prior to MDCT; To avoid systematic bias in performance or image quality due to dilution of the contrast enhancement within the joint, the order of the CBCT and the MDCT will be randomized. This arm is composed of patients who will have the CBCT performed prior to the MDCT.	Device: CBCT prior to MDCT; Cone-beam scanner is performed immediately after arthrography, then multidetector scanner is performed.
Experimental: MDCT prior to CBCT; To avoid systematic bias in performance or image quality due to dilution of the contrast enhancement within the joint, the order of the CBCT and the MDCT will be randomized. This arm is composed of patients who will have the MDCT performed prior to the CBCT.	Device: MDCT prior to CBCT; Multidetector scanner is performed immediately after arthrography, then Cone-beam scanner is performed.

Outcome Measures

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Primary Outcome Measures :

1. cartilage damage thickness [ Time Frame: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours ]
   0- normal, 1- Linear cartilage tear, 2- focal ulceration of less than 50% of the cartilage thickness, 3-: - focal ulceration of greater than 50% of the cartilage thickness, 4- Full thickness ulceration of the cartilage

Secondary Outcome Measures :

1. cartilage damage measurements [ Time Frame: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours ]
   Quantitative assessment of each location of cartilage damage by maximal diameter in two orthogonal planes tangential to the surface
2. Image quality (for CBCT and MDCT) [ Time Frame: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours ]
   0 - Insufficient, 1 - Poor, 2 - Average, 3 - Good, 4 - Excellent
3. Tolerability of the exam (for CBCT and MDCT) [ Time Frame: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours ]
   Perfect, tolerable, hardly tolerable, intolerable
4. Duration of the exam (for CBCT and MDCT) [ Time Frame: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours ]
   Perfect, tolerable, hardly tolerable, intolerable
5. Subchondral bone lesion (for CBCT and MDCT) [ Time Frame: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours ]
   No subchondral bone lesion, subchondral bone thickening, subchondral cyst <3mm diameter, subchondral cyst 3 to 5 mm diameter, subchondral cyst >5mm diameter
6. Lesion of intrinsic ligament (for CBCT and MDCT) [ Time Frame: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours ]
   Yes / No
7. Osteochondroma (for CBCT and MDCT) [ Time Frame: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours ]
   Each osteochondroma is located (anterior/posterior Medial/ lateral recess, and diameter is measured.: >3mm, 3 to 5 mm, >5mm
8. Meniscal lesion (for arthrography CBCT and MDCT of the knee) [ Time Frame: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours ]
   No lesion, longitudinal tear, radial tear, complex tear, displaced tear, bucket handle tear

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Patient age 18 years old or above, weight ≤ 160 Kg
• Patient require knee or ankle or elbow or wrist arthroscanner
• French spoken an read
• Free and informed consent signed
• Being affiliated to a French social security system or similar.

Exclusion Criteria:

• Patients already included in the ARCOBE study
• Patient with severe pain and reduced spontaneous mobility that could prevent proper positioning for the cone-beam
• Lack of effective contraception (risk of pregnancy) or pregnancy proven data on interrogations
• Patient on protection of the court, under supervision or trusteeship
• Inability to express a consent
• Patients already enrolled in a study with a conflict of interest with this study.

Contacts and Locations

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Locations

France
Hospices Civils de Lyon- hôpital Edouard Herriot- service de radiologie pavillon B
Lyon, France, 69003

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator:	Jean-Baptiste PIALAT, MD	Hospices Civils de Lyon- Hôpital Edouard Herriot

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT01771393 History of Changes
Other Study ID Numbers:	2012.711
First Posted:	January 18, 2013
Last Update Posted:	August 5, 2013
Last Verified:	August 2013

Keywords provided by Hospices Civils de Lyon:

arthroscanner; cone-beam computed tomodensitometry