Cartilage Ulceration of the Distal JointsARCOBENCT01771393
Cone-beam vs Multidetector Computed Tomography (CT) for Arthrography of the Wrist, Ankle, Elbow and Knee
A study testing CBCT prior to MDCT and MDCT prior to CBCT in people with Cartilage Ulceration of the Distal Joints, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cartilage Ulceration of the Distal Joints
- What is being tested?
- CBCT prior to MDCT and MDCT prior to CBCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon- hôpital Edouard Herriot- service de radiologie pavillon B
Lyon, 69003
About this study
Official title: Performance of Cone-beam Computed Tomography (CT) Compared to Multidetector 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).
- Being tested
- CBCT prior to MDCT, MDCT prior to CBCT
- Keywords
- arthroscanner, cone-beam computed tomodensitometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCT prior to MDCTDevice
Cone-beam scanner is performed immediately after arthrography, then multidetector scanner is performed.
MDCT prior to CBCTDevice
Multidetector scanner is performed immediately after arthrography, then Cone-beam scanner is performed.
| Study group | Role | What they receive |
|---|---|---|
| CBCT prior to MDCT | Experimental | 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. Receives: Device: CBCT prior to MDCT |
| MDCT prior to CBCT | Experimental | 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. Receives: Device: MDCT prior to CBCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours
Secondary outcomes (8)
cartilage damage measurements
Quantitative assessment of each location of cartilage damage by maximal diameter in two orthogonal planes tangential to the surface
Measured: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours
Image quality (for CBCT and MDCT)
0 - Insufficient, 1 - Poor, 2 - Average, 3 - Good, 4 - Excellent
Measured: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours
Tolerability of the exam (for CBCT and MDCT)
Perfect, tolerable, hardly tolerable, intolerable
Measured: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours
Duration of the exam (for CBCT and MDCT)
Perfect, tolerable, hardly tolerable, intolerable
Measured: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours
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
Measured: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours
Lesion of intrinsic ligament (for CBCT and MDCT)
Yes / No
Measured: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours
Osteochondroma (for CBCT and MDCT)
Each osteochondroma is located (anterior/posterior Medial/ lateral recess, and diameter is measured.: >3mm, 3 to 5 mm, >5mm
Measured: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours
Meniscal lesion (for arthrography CBCT and MDCT of the knee)
No lesion, longitudinal tear, radial tear, complex tear, displaced tear, bucket handle tear
Measured: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startJul 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cartilage Ulceration of the Distal JointsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Baptiste PIALAT, MD, Principal investigator, Hospices Civils de Lyon- Hôpital Edouard Herriot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771393
- Sponsor's protocol ID
- 2012.711
- Acronym
- ARCOBE
- Status last verified
- Dec 2025
- First submitted
- 18 Oct 2012
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Debeaupte M, Hermann R, Pialat JB, Martinon A, Truy E, Ltaief Boudrigua A. Cone beam versus multi-detector computed tomography for detecting hearing loss. Eur Arch Otorhinolaryngol. 2019 Feb;276(2):315-321. doi: 10.1007/s00405-018-5214-y. Epub 2018 Nov 23.
PubMed 30467778
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Cone-beam Computed Tomography (CT) Compared to Multidetector CT for Arthrography of the Wrist, Ankle, Elbow and Knee
- ClinicalTrials.gov ID
- NCT01771393
- Acronym / sponsor ID
- ARCOBE / 2012.711
- Keywords
- arthroscanner, cone-beam computed tomodensitometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 18 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBCT prior to MDCT | Experimental | Device: CBCT prior to MDCTTo 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. |
| MDCT prior to CBCT | Experimental | Device: MDCT prior to CBCTTo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBCT prior to MDCTCone-beam scanner is performed immediately after arthrography, then multidetector scanner is performed. | Device | CBCT prior to MDCT |
| MDCT prior to CBCTMultidetector scanner is performed immediately after arthrography, then Cone-beam scanner is performed. | Device | MDCT prior to CBCT |
Primary outcome
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
8 secondary outcomes
cartilage damage measurements
Time frame: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours
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
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
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
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
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
Osteochondroma (for CBCT and MDCT)
Time frame: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 30467778Debeaupte M, Hermann R, Pialat JB, Martinon A, Truy E, Ltaief Boudrigua A. Cone beam versus multi-detector computed tomography for detecting hearing loss. Eur Arch Otorhinolaryngol. 2019 Feb;276(2):315-321. doi: 10.1007/s00405-018-5214-y. Epub 2018 Nov 23.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Baptiste PIALAT, MD principal investigator
Hospices Civils de Lyon- Hôpital Edouard Herriot
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBCT prior to MDCT and MDCT prior to CBCT in people with Cartilage Ulceration of the Distal Joints, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cartilage damage thickness (time frame: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01771393, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.