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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01771393
First received: October 18, 2012
Last updated: August 2, 2013
Last verified: August 2013
  Purpose

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).


Condition Intervention
Cartilage Ulceration of the Distal Joints
Device: CBCT prior to MDCT
Device: MDCT prior to CBCT

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Performance of Cone-beam Computed Tomography (CT) Compared to Multidetector CT for Arthrography of the Wrist, Ankle, Elbow and Knee

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • cartilage damage thickness [ Time Frame: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • cartilage damage measurements [ Time Frame: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours ] [ Designated as safety issue: No ]
    Quantitative assessment of each location of cartilage damage by maximal diameter in two orthogonal planes tangential to the surface

  • 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 ] [ Designated as safety issue: No ]
    0 - Insufficient, 1 - Poor, 2 - Average, 3 - Good, 4 - Excellent

  • 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 ] [ Designated as safety issue: No ]
    Perfect, tolerable, hardly tolerable, intolerable

  • 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 ] [ Designated as safety issue: No ]
    Perfect, tolerable, hardly tolerable, intolerable

  • 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 ] [ Designated as safety issue: No ]
    No subchondral bone lesion, subchondral bone thickening, subchondral cyst <3mm diameter, subchondral cyst 3 to 5 mm diameter, subchondral cyst >5mm diameter

  • 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 ] [ Designated as safety issue: No ]
    Yes / No

  • Osteochondroma (for CBCT and MDCT) [ Time Frame: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours ] [ Designated as safety issue: No ]
    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) [ Time Frame: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours ] [ Designated as safety issue: No ]
    No lesion, longitudinal tear, radial tear, complex tear, displaced tear, bucket handle tear


Enrollment: 69
Study Start Date: July 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771393

Locations
France
Hospices Civils de Lyon- hôpital Edouard Herriot- service de radiologie pavillon B
Lyon, France, 69003
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Jean-Baptiste PIALAT, MD Hospices Civils de Lyon- Hôpital Edouard Herriot
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01771393     History of Changes
Other Study ID Numbers: 2012.711
Study First Received: October 18, 2012
Last Updated: August 2, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Hospices Civils de Lyon:
arthroscanner
cone-beam computed tomodensitometry

Additional relevant MeSH terms:
Ulcer
Pathologic Processes

ClinicalTrials.gov processed this record on August 25, 2014