Cone-beam vs Multidetector Computed Tomography (CT) for Arthrography of the Wrist, Ankle, Elbow and Knee (ARCOBE)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01771393 |
Recruitment Status
:
Completed
First Posted
: January 18, 2013
Last Update Posted
: August 5, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cartilage Ulceration of the Distal Joints | Device: CBCT prior to MDCT Device: MDCT prior to CBCT | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 69 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (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 |
Study Start Date : | July 2012 |
Actual Primary Completion Date : | June 2013 |
Actual Study Completion Date : | June 2013 |

Arm | Intervention/treatment |
---|---|
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.
|
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771393
France | |
Hospices Civils de Lyon- hôpital Edouard Herriot- service de radiologie pavillon B | |
Lyon, France, 69003 |
Principal Investigator: | Jean-Baptiste PIALAT, MD | Hospices Civils de Lyon- Hôpital Edouard Herriot |
Responsible Party: | Hospices Civils de Lyon |
ClinicalTrials.gov Identifier: | NCT01771393 History of Changes |
Other Study ID Numbers: |
2012.711 |
First Posted: | January 18, 2013 Key Record Dates |
Last Update Posted: | August 5, 2013 |
Last Verified: | August 2013 |
Keywords provided by Hospices Civils de Lyon:
arthroscanner cone-beam computed tomodensitometry |