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

Cartilage Lesion Clinical Trial

— Arthro-CBCT  

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05203757
• Other study ID #: APHP211118
• Secondary ID: 021-A01771-40
• Status: Completed
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: August 15, 2023

Study information

• Verified date: April 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• 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: Completed
• Enrollment: 35
• Est. completion date: August 15, 2023
• Est. primary completion date: August 15, 2023
• 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.

Related Conditions & MeSH terms

• Cartilage Lesion

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