Cartilage Ulceration of the Distal Joints
Conditions
Keywords
arthroscanner, cone-beam computed tomodensitometry
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).
Interventions
DEVICECBCT prior to MDCT
Cone-beam scanner is performed immediately after arthrography, then multidetector scanner is performed.
DEVICEMDCT prior to CBCT
Multidetector scanner is performed immediately after arthrography, then Cone-beam scanner is performed.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cartilage damage thickness | 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
| Measure | Time frame | Description |
|---|---|---|
| Image quality (for CBCT and MDCT) | 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 |
| Tolerability of the exam (for CBCT and MDCT) | participants will be followed for the duration of the arthrography CT , an expected average of 2 hours | Perfect, tolerable, hardly tolerable, intolerable |
| Duration of the exam (for CBCT and MDCT) | participants will be followed for the duration of the arthrography CT , an expected average of 2 hours | Perfect, tolerable, hardly tolerable, intolerable |
| cartilage damage measurements | 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 |
| Lesion of intrinsic ligament (for CBCT and MDCT) | participants will be followed for the duration of the arthrography CT , an expected average of 2 hours | Yes / No |
| Osteochondroma (for CBCT and MDCT) | 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 |
| Meniscal lesion (for arthrography CBCT and MDCT of the knee) | 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 |
| Subchondral bone lesion (for CBCT and MDCT) | 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 |
Countries
France
Outcome results
None listed