Clinical trial NCT01771393: Cone-beam vs Multidetector Computed Tomography (CT) for Arthrography of the Wrist, Ankle, Elbow and Knee
Official title: Performance of Cone-beam Computed Tomography (CT) Compared to Multidetector CT for Arthrography of the Wrist, Ankle, Elbow and Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cartilage Ulceration of the Distal Joints
Keywords: arthroscanner
cone-beam computed tomodensitometry
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-01-18
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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).


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.

Primary outcomes:
measure: cartilage damage thickness
timeFrame: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours
Secondary outcomes:
measure: cartilage damage measurements
timeFrame: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours
measure: Image quality (for CBCT and MDCT)
timeFrame: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours
measure: Tolerability of the exam (for CBCT and MDCT)
timeFrame: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours
measure: Duration of the exam (for CBCT and MDCT)
timeFrame: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours
measure: Subchondral bone lesion (for CBCT and MDCT)
timeFrame: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours
measure: Lesion of intrinsic ligament (for CBCT and MDCT)
timeFrame: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours
measure: Osteochondroma (for CBCT and MDCT)
timeFrame: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours
measure: Meniscal lesion (for arthrography CBCT and MDCT of the knee)
timeFrame: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon- hôpital Edouard Herriot- service de radiologie pavillon B
Study officials:
affiliation: Hospices Civils de Lyon- Hôpital Edouard Herriot
name: Jean-Baptiste PIALAT, MD
role: PRINCIPAL_INVESTIGATOR
References: