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

Primary Purpose

Cartilage Ulceration of the Distal Joints

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CBCT prior to MDCT
MDCT prior to CBCT
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cartilage Ulceration of the Distal Joints focused on measuring arthroscanner, cone-beam computed tomodensitometry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CBCT prior to MDCT

MDCT prior to CBCT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

cartilage damage thickness
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
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)
0 - Insufficient, 1 - Poor, 2 - Average, 3 - Good, 4 - Excellent
Tolerability of the exam (for CBCT and MDCT)
Perfect, tolerable, hardly tolerable, intolerable
Duration of the exam (for CBCT and MDCT)
Perfect, tolerable, hardly tolerable, intolerable
Subchondral bone lesion (for CBCT and MDCT)
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)
Yes / No
Osteochondroma (for CBCT and MDCT)
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)
No lesion, longitudinal tear, radial tear, complex tear, displaced tear, bucket handle tear

Full Information

First Posted
October 18, 2012
Last Updated
August 2, 2013
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT01771393
Brief Title
Cone-beam vs Multidetector Computed Tomography (CT) for Arthrography of the Wrist, Ankle, Elbow and Knee
Acronym
ARCOBE
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

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cartilage Ulceration of the Distal Joints
Keywords
arthroscanner, cone-beam computed tomodensitometry

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBCT prior to MDCT
Arm Type
Experimental
Arm Description
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.
Arm Title
MDCT prior to CBCT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
CBCT prior to MDCT
Intervention Description
Cone-beam scanner is performed immediately after arthrography, then multidetector scanner is performed.
Intervention Type
Device
Intervention Name(s)
MDCT prior to CBCT
Intervention Description
Multidetector scanner is performed immediately after arthrography, then Cone-beam scanner is performed.
Primary Outcome Measure Information:
Title
cartilage damage thickness
Description
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
Time Frame
participants will be followed for the duration of the arthrography CT , an expected average of 2 hours
Secondary Outcome Measure Information:
Title
cartilage damage measurements
Description
Quantitative assessment of each location of cartilage damage by maximal diameter in two orthogonal planes tangential to the surface
Time Frame
participants will be followed for the duration of the arthrography CT , an expected average of 2 hours
Title
Image quality (for CBCT and MDCT)
Description
0 - Insufficient, 1 - Poor, 2 - Average, 3 - Good, 4 - Excellent
Time Frame
participants will be followed for the duration of the arthrography CT , an expected average of 2 hours
Title
Tolerability of the exam (for CBCT and MDCT)
Description
Perfect, tolerable, hardly tolerable, intolerable
Time Frame
participants will be followed for the duration of the arthrography CT , an expected average of 2 hours
Title
Duration of the exam (for CBCT and MDCT)
Description
Perfect, tolerable, hardly tolerable, intolerable
Time Frame
participants will be followed for the duration of the arthrography CT , an expected average of 2 hours
Title
Subchondral bone lesion (for CBCT and MDCT)
Description
No subchondral bone lesion, subchondral bone thickening, subchondral cyst <3mm diameter, subchondral cyst 3 to 5 mm diameter, subchondral cyst >5mm diameter
Time Frame
participants will be followed for the duration of the arthrography CT , an expected average of 2 hours
Title
Lesion of intrinsic ligament (for CBCT and MDCT)
Description
Yes / No
Time Frame
participants will be followed for the duration of the arthrography CT , an expected average of 2 hours
Title
Osteochondroma (for CBCT and MDCT)
Description
Each osteochondroma is located (anterior/posterior Medial/ lateral recess, and diameter is measured.: >3mm, 3 to 5 mm, >5mm
Time Frame
participants will be followed for the duration of the arthrography CT , an expected average of 2 hours
Title
Meniscal lesion (for arthrography CBCT and MDCT of the knee)
Description
No lesion, longitudinal tear, radial tear, complex tear, displaced tear, bucket handle tear
Time Frame
participants will be followed for the duration of the arthrography CT , an expected average of 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Baptiste PIALAT, MD
Organizational Affiliation
Hospices Civils de Lyon- Hôpital Edouard Herriot
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon- hôpital Edouard Herriot- service de radiologie pavillon B
City
Lyon
ZIP/Postal Code
69003
Country
France

12. IPD Sharing Statement

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

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