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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05203757
Other study ID # APHP211118
Secondary ID 021-A01771-40
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 2022
Est. completion date October 2022

Study information

Verified date December 2021
Source Assistance Publique - Hôpitaux de Paris
Contact Mickael TORDJMAN, MD
Phone + 33 (0)1 71 14 19 20
Email mickael.tordjman@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date October 2022
Est. primary completion date June 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients aged = 18 years; - Patients require CT arthrogram of the ankle; - Affiliated to a social security schema; - Informed consent signed by patients. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
ArthroCT scan
Conventional CT arthrogram as routine care
CBCT
Cone Beam CT scan.

Locations

Country Name City State
France Radiological department, Raymond Poincaré hospital, APHP Garches

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Localisation of the lesions Localisation of cartilage and osteochondral lesions assessed by CT scan at baseline
Primary Number of the lesions Number of cartilage and osteochondral lesions assessed by CT scan at baseline
Primary Size of the lesions Size of cartilage and osteochondral lesions assessed by CT scan at baseline
Primary Unstable displaced lesions Displaced osteochondral fragment in the joint. at baseline
Primary Unstable non-displaced lesions Contrast enhanced fluid from the arthrogram surrounding the osteochondral fragment. at baseline
See also
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