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OpenTrials
Completed

NCT Number: NCT05203757

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

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.

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Key information

Conditions

Cartilage Lesion Osteochondral Lesion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radiological department, Raymond Poincaré hospital, APHP

Garches, 92380, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ArthroCT scan

Procedure

Conventional CT arthrogram as routine care

CBCT

Procedure

Cone Beam CT scan.

Primary outcomes

  1. Localisation of the lesions

    Time frame: at baseline

    Localisation of cartilage and osteochondral lesions assessed by CT scan

  2. Number of the lesions

    Time frame: at baseline

    Number of cartilage and osteochondral lesions assessed by CT scan

  3. Size of the lesions

    Time frame: at baseline

    Size of cartilage and osteochondral lesions assessed by CT scan

  4. Unstable displaced lesions

    Time frame: at baseline

    Displaced osteochondral fragment in the joint.

  5. Unstable non-displaced lesions

    Time frame: at baseline

    Contrast enhanced fluid from the arthrogram surrounding the osteochondral fragment.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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?

Acronym: Arthro-CBCT

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 24, 2022
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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