Clinical trial NCT05203757: Cone Beam CT (CBCT) Arthrogram of the Ankle in Assessement of Osteochondral or Cartilage Lesions
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?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cartilage Lesion
Osteochondral Lesion
Keywords: Cartilage Lesion
Osteochondral Lesion
Osteochondral Defect
Cone Beam arthrogram
CBCT arthrogram
CT arthrogram
Weight bearing CBCT
Ankle
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Localisation of the lesions
timeFrame: at baseline
measure: Number of the lesions
timeFrame: at baseline
measure: Size of the lesions
timeFrame: at baseline
measure: Unstable displaced lesions
timeFrame: at baseline
measure: Unstable non-displaced lesions
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Garches
country: France
facility: Radiological department, Raymond Poincaré hospital, APHP
Study officials:
affiliation: Radiological department - Raymond Poincaré hospital - APHP
name: Mickael TORDJMAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.