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

Not Applicable

Completed

• Conditions: Osteochondral Lesion; Cartilage Lesion
• Interventions: Procedure: ArthroCT scan; Procedure: CBCT

• Registration Number: NCT05203757
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2021-12-09
• Study First Submitted QC: 2022-01-21
• Study First Posted: 2022-01-24
• Study Start: 2022-02-15
• Primary Completion: 2023-08-15
• Study Completion: 2023-08-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Conventional CT-arthrogram + CBCT arthrogram	CBCT	Conventional CT-arthrogram + CBCT arthrogram (CBCT in the minutes following the conventional CT arthrogram). Routine care (arthroCT) and CBCT of ankle.
Conventional CT-arthrogram + CBCT arthrogram	ArthroCT scan	Conventional CT-arthrogram + CBCT arthrogram (CBCT in the minutes following the conventional CT arthrogram). Routine care (arthroCT) and CBCT of ankle.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Radiological department, Raymond Poincaré hospital, APHP; 🇫🇷 Garches, France