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

Performance of Cone-beam Computed Tomography (CT) Compared to Multidetector CT for Arthrography of the Wrist, Ankle, Elbow and Knee

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).

Study Overview

• Status: Completed
• Conditions: Cartilage Ulceration of the Distal Joints
• Intervention / Treatment: Device: CBCT prior to MDCT; Device: MDCT prior to CBCT

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cartilage damage thickness	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	participants will be followed for the duration of the arthrography CT , an expected average of 2 hours

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: October 18, 2012
• First Submitted That Met QC Criteria: January 16, 2013
• First Posted (Estimate): January 18, 2013

Study Record Updates

• Last Update Posted (Estimate): August 5, 2013
• Last Update Submitted That Met QC Criteria: August 2, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: arthroscanner; cone-beam computed tomodensitometry
• Additional Relevant MeSH Terms: Pathologic Processes; Ulcer
• Other Study ID Numbers: 2012.711