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

NCT ID: NCT05203757

Last Updated: 2024-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-15

Study Completion Date

2023-08-15

Brief Summary

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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

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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.

Conditions

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Cartilage Lesion Osteochondral Lesion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

ArthroCT scan

Intervention Type PROCEDURE

Conventional CT arthrogram as routine care

CBCT

Intervention Type PROCEDURE

Cone Beam CT scan.

Interventions

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ArthroCT scan

Conventional CT arthrogram as routine care

Intervention Type PROCEDURE

CBCT

Cone Beam CT scan.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mickael TORDJMAN, MD

Role: PRINCIPAL_INVESTIGATOR

Radiological department - Raymond Poincaré hospital - APHP

Locations

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Radiological department, Raymond Poincaré hospital, APHP

Garches, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 33713874 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33280057 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33798932 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30498800 (View on PubMed)

Other Identifiers

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021-A01771-40

Identifier Type: REGISTRY

Identifier Source: secondary_id

APHP211118

Identifier Type: -

Identifier Source: org_study_id

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