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

May 14, 2024 updated by: Assistance Publique - Hôpitaux de Paris

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?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Garches, France, 92380
        • Radiological department, Raymond Poincaré hospital, APHP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2022

Primary Completion (Actual)

August 15, 2023

Study Completion (Actual)

August 15, 2023

Study Registration Dates

First Submitted

December 9, 2021

First Submitted That Met QC Criteria

January 21, 2022

First Posted (Actual)

January 24, 2022

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 14, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • APHP211118
  • 021-A01771-40 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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