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

NCT ID: NCT01771393

Last Updated: 2013-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-06-30

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).

Conditions

Cartilage Ulceration of the Distal Joints

Keywords

arthroscanner; cone-beam computed tomodensitometry

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CBCT prior to MDCT

Intervention Type: DEVICE

Cone-beam scanner is performed immediately after arthrography, then multidetector scanner is performed.

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.

Group Type: EXPERIMENTAL

MDCT prior to CBCT

Intervention Type: DEVICE

Multidetector scanner is performed immediately after arthrography, then Cone-beam scanner is performed.

Interventions

CBCT prior to MDCT

Cone-beam scanner is performed immediately after arthrography, then multidetector scanner is performed.

Intervention Type: DEVICE

MDCT prior to CBCT

Multidetector scanner is performed immediately after arthrography, then Cone-beam scanner is performed.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Baptiste PIALAT, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon- Hôpital Edouard Herriot

Locations

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

Lyon, , France

Countries

France

Other Identifiers

2012.711

Identifier Type: -

Identifier Source: org_study_id