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Completed

NCT Number: NCT01771393

Cone-beam vs Multidetector Computed Tomography (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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CBCT prior to MDCT

Device

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

MDCT prior to CBCT

Device

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: ARCOBE

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 18, 2013
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.