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

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05203757
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 9
• Patients Per Site Per Month: 6.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cartilage Lesion; Osteochondral Lesion	Procedure: ArthroCT scan; Procedure: CBCT	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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?
• Anticipated Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Conventional CT-arthrogram + CBCT arthrogram Conventional CT-arthrogram + CBCT arthrogram (CBCT in the minutes following the conventional CT arthrogram). Routine care (arthroCT) and CBCT of ankle.	Procedure: ArthroCT scan; Conventional CT arthrogram as routine care; Procedure: CBCT; Cone Beam CT scan.

Outcome Measures

Primary Outcome Measures

1. Localisation of the lesions [at baseline]

   Localisation of cartilage and osteochondral lesions assessed by CT scan

2. Number of the lesions [at baseline]

   Number of cartilage and osteochondral lesions assessed by CT scan

3. Size of the lesions [at baseline]

   Size of cartilage and osteochondral lesions assessed by CT scan

4. Unstable displaced lesions [at baseline]

   Displaced osteochondral fragment in the joint.

5. Unstable non-displaced lesions [at baseline]

   Contrast enhanced fluid from the arthrogram surrounding the osteochondral fragment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radiological department, Raymond Poincaré hospital, APHP	Garches		France	92380

Sponsors and Collaborators

• Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: Mickael TORDJMAN, MD, Radiological department - Raymond Poincaré hospital - APHP

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT05203757
• Other Study ID Numbers: APHP211118; 021-A01771-40
• First Posted: Jan 24, 2022
• Last Update Posted: Jan 24, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Assistance Publique - Hôpitaux de Paris: Cartilage Lesion; Osteochondral Lesion; Osteochondral Defect; Cone Beam arthrogram; CBCT arthrogram; CT arthrogram; Weight bearing CBCT; Ankle

Study Results

No Results Posted as of Jan 24, 2022