Cartilage LesionArthro-CBCTNCT05203757

Cone Beam CT (CBCT) Arthrogram of the Ankle in Assessement of Osteochondral or Cartilage Lesions

A study testing ArthroCT scan and CBCT in people with Cartilage Lesion and Osteochondral Lesion, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aims to compare weight-bearing Cone Beam CT arthrogram and conventional CT arthrogram in assessement of patients with ankle osteo-chondral or cartilage lesions. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cartilage Lesion, Osteochondral Lesion
What is being tested?: ArthroCT scan and CBCT
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteFrance
Study dates: 15 Feb 2022to 15 Aug 2023
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

Patients aged ≥ 18 years;
Patients require CT arthrogram of the ankle;
Affiliated to a social security schema;
Informed consent signed by patients.

Who cannot join

Pregnant women;
Impossibility of injection of intra-articular contrast product;
Hypersensitivity reactions to iodinated contrast agent;
Patient refusal;
Patient under french AME scheme;
Patient under guardianship by tutor or curator.

Trial locations and contacts

1 site in 1 country.

France1 site

Radiological department, Raymond Poincaré hospital, APHP
Garches, 92380

Other trials in France

About this study

Official title: Weight-Bearing Cone Beam CT Arthrogram of the Ankle: a Lower Radiation Dose Technique to Evaluate Osteo-chondral Lesions or Cartilage Lesions: Is it the Future of the arthroCT?

This study aims to compare weight-bearing Cone Beam CT arthrogram and conventional CT arthrogram in assessement of patients with ankle osteo-chondral or cartilage lesions.

Read the detailed description

Weight-bearing Cone Beam CT (CBCT) arthrogram, a technique with less radiation dose than conventional CT, is hypothesized non-inferior to conventional CT arthrogram to diagnose osteo-chondral (OCL) or cartilage lesions of the ankle.

Conditions: Cartilage Lesion, Osteochondral Lesion
Being tested: ArthroCT scan, CBCT
Keywords: Cartilage Lesion, Osteochondral Lesion, Osteochondral Defect, Cone Beam arthrogram, CBCT arthrogram, CT arthrogram, Weight bearing CBCT, Ankle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ArthroCT scanProcedure or surgery
Conventional CT arthrogram as routine care
CBCTProcedure or surgery
Cone Beam CT scan.

Study groups in NCT05203757
Study group	Role	What they receive
Conventional CT-arthrogram + CBCT arthrogram	Experimental	Conventional CT-arthrogram + CBCT arthrogram (CBCT in the minutes following the conventional CT arthrogram). Routine care (arthroCT) and CBCT of ankle. Receives: Procedure: ArthroCT scan; Procedure: CBCT

What is being measured

The primary outcome is the main question the study is designed to answer.

Localisation of the lesions
Localisation of cartilage and osteochondral lesions assessed by CT scan
Measured: at baseline
Number of the lesions
Number of cartilage and osteochondral lesions assessed by CT scan
Measured: at baseline
Size of the lesions
Size of cartilage and osteochondral lesions assessed by CT scan
Measured: at baseline
Unstable displaced lesions
Displaced osteochondral fragment in the joint.
Measured: at baseline
Unstable non-displaced lesions
Contrast enhanced fluid from the arthrogram surrounding the osteochondral fragment.
Measured: at baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 202215 Aug 2023

First posted24 Jan 2022
Study start15 Feb 2022
Primary completion15 Aug 2023
Study completion15 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Cartilage LesionStudies of the same condition, open and under way.
More trials run by Assistance Publique - Hôpitaux de ParisThe 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05203757
Sponsor's protocol ID: APHP211118
Other IDs: 021-A01771-40
Acronym: Arthro-CBCT
Status last verified: Apr 2024
First submitted: 9 Dec 2021
Last updated: 16 May 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Lopes R, Geffroy L, Padiolleau G, Ngbilo C, Baudrier N, Mainard D, Benoist J, Leiber Wackenheim F, Cordier G, Dubois Ferriere V, Freychet B, Barbier O, Amouyel T. Proposal of a new CT arthrographic classification system of osteochondral lesions of the talus. Orthop Traumatol Surg Res. 2021 Oct;107(6):102890. doi: 10.1016/j.otsr.2021.102890. Epub 2021 Mar 10.
PubMed 33713874
Grunz JP, Pennig L, Fieber T, Gietzen CH, Heidenreich JF, Huflage H, Gruschwitz P, Kuhl PJ, Petritsch B, Kosmala A, Bley TA, Gassenmaier T. Twin robotic x-ray system in small bone and joint trauma: impact of cone-beam computed tomography on treatment decisions. Eur Radiol. 2021 Jun;31(6):3600-3609. doi: 10.1007/s00330-020-07563-5. Epub 2020 Dec 5.
PubMed 33280057
Broos M, Berardo S, Dobbe JGG, Maas M, Streekstra GJ, Wellenberg RHH. Geometric 3D analyses of the foot and ankle using weight-bearing and non weight-bearing cone-beam CT images: The new standard? Eur J Radiol. 2021 May;138:109674. doi: 10.1016/j.ejrad.2021.109674. Epub 2021 Mar 20.
PubMed 33798932
Posadzy M, Desimpel J, Vanhoenacker F. Staging of Osteochondral Lesions of the Talus: MRI and Cone Beam CT. J Belg Soc Radiol. 2017 Dec 16;101(Suppl 2):1. doi: 10.5334/jbr-btr.1377.
PubMed 30498800

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Weight-Bearing Cone Beam CT Arthrogram of the Ankle: a Lower Radiation Dose Technique to Evaluate Osteo-chondral Lesions or Cartilage Lesions: Is it the Future of the arthroCT?
ClinicalTrials.gov ID: NCT05203757
Acronym / sponsor ID: Arthro-CBCT / APHP211118
Conditions: Cartilage Lesion, Osteochondral Lesion
Keywords: Cartilage Lesion, Osteochondral Lesion, Osteochondral Defect, Cone Beam arthrogram, CBCT arthrogram, CT arthrogram, Weight bearing CBCT, Ankle
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
Study start: 15 Feb 2022 (actual)
Primary completion: 15 Aug 2023 (actual)
Study completion: 15 Aug 2023 (actual)
First posted: 24 Jan 2022 (actual)
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.

This study aims to compare weight-bearing Cone Beam CT arthrogram and conventional CT arthrogram in assessement of patients with ankle osteo-chondral or cartilage lesions.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Conventional CT-arthrogram + CBCT arthrogram	Experimental	Procedure: ArthroCT scan, Procedure: CBCTConventional CT-arthrogram + CBCT arthrogram (CBCT in the minutes following the conventional CT arthrogram). Routine care (arthroCT) and CBCT of ankle.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients aged ≥ 18 years;
Patients require CT arthrogram of the ankle;
Affiliated to a social security schema;
Informed consent signed by patients.

Key exclusion criteria (6 listed)

Pregnant women;
Impossibility of injection of intra-articular contrast product;
Hypersensitivity reactions to iodinated contrast agent;
Patient refusal;
Patient under french AME scheme;

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
ArthroCT scanConventional CT arthrogram as routine care	Procedure or surgery	Conventional CT-arthrogram + CBCT arthrogram
CBCTCone Beam CT scan.	Procedure or surgery	Conventional CT-arthrogram + CBCT arthrogram

Primary outcome

Localisation of the lesions
Time frame: at baseline
Localisation of cartilage and osteochondral lesions assessed by CT scan
Number of the lesions
Time frame: at baseline
Number of cartilage and osteochondral lesions assessed by CT scan
Size of the lesions
Time frame: at baseline
Size of cartilage and osteochondral lesions assessed by CT scan
Unstable displaced lesions
Time frame: at baseline
Displaced osteochondral fragment in the joint.
Unstable non-displaced lesions
Time frame: at baseline
Contrast enhanced fluid from the arthrogram surrounding the osteochondral fragment.

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 16 May 2024.
Background: PubMed 33713874Lopes R, Geffroy L, Padiolleau G, Ngbilo C, Baudrier N, Mainard D, Benoist J, Leiber Wackenheim F, Cordier G, Dubois Ferriere V, Freychet B, Barbier O, Amouyel T. Proposal of a new CT arthrographic classification system of osteochondral lesions of the talus. Orthop Traumatol Surg Res. 2021 Oct;107(6):102890. doi: 10.1016/j.otsr.2021.102890. Epub 2021 Mar 10.
Background: PubMed 33280057Grunz JP, Pennig L, Fieber T, Gietzen CH, Heidenreich JF, Huflage H, Gruschwitz P, Kuhl PJ, Petritsch B, Kosmala A, Bley TA, Gassenmaier T. Twin robotic x-ray system in small bone and joint trauma: impact of cone-beam computed tomography on treatment decisions. Eur Radiol. 2021 Jun;31(6):3600-3609. doi: 10.1007/s00330-020-07563-5. Epub 2020 Dec 5.
Background: PubMed 33798932Broos M, Berardo S, Dobbe JGG, Maas M, Streekstra GJ, Wellenberg RHH. Geometric 3D analyses of the foot and ankle using weight-bearing and non weight-bearing cone-beam CT images: The new standard? Eur J Radiol. 2021 May;138:109674. doi: 10.1016/j.ejrad.2021.109674. Epub 2021 Mar 20.
Background: PubMed 30498800Posadzy M, Desimpel J, Vanhoenacker F. Staging of Osteochondral Lesions of the Talus: MRI and Cone Beam CT. J Belg Soc Radiol. 2017 Dec 16;101(Suppl 2):1. doi: 10.5334/jbr-btr.1377.
Individual participant dataSharing planned: No

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A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
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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.

Mickael TORDJMAN, MD principal investigator

Radiological department - Raymond Poincaré hospital - APHP

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ArthroCT scan and CBCT in people with Cartilage Lesion and Osteochondral Lesion, run by Assistance Publique - Hôpitaux de Paris 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 4 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 16 May 2024. 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?

Localisation of the lesions (time frame: at baseline). The study lists 5 primary outcomes in all. 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 NCT05203757, which also lists 4 linked publications.

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 16 May 2024.