NCT05203757

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 24, 2022

Completed
22 days until next milestone

Study Start

First participant enrolled

February 15, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

May 16, 2024

Status Verified

April 1, 2024

Enrollment Period

1.5 years

First QC Date

December 9, 2021

Last Update Submit

May 14, 2024

Conditions

Cartilage LesionOsteochondral Lesion

Keywords

Cartilage LesionOsteochondral LesionOsteochondral DefectCone Beam arthrogramCBCT arthrogramCT arthrogramWeight bearing CBCTAnkle

Outcome Measures

Primary Outcomes (5)

  • Localisation of the lesions

    Localisation of cartilage and osteochondral lesions assessed by CT scan

    at baseline

  • Number of the lesions

    Number of cartilage and osteochondral lesions assessed by CT scan

    at baseline

  • Size of the lesions

    Size of cartilage and osteochondral lesions assessed by CT scan

    at baseline

  • Unstable displaced lesions

    Displaced osteochondral fragment in the joint.

    at baseline

  • Unstable non-displaced lesions

    Contrast enhanced fluid from the arthrogram surrounding the osteochondral fragment.

    at baseline

Study Arms (1)

Conventional CT-arthrogram + CBCT arthrogram

EXPERIMENTAL

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

Procedure: ArthroCT scanProcedure: CBCT

Interventions

ArthroCT scanPROCEDURE

Conventional CT arthrogram as routine care

Conventional CT-arthrogram + CBCT arthrogram
CBCTPROCEDURE

Cone Beam CT scan.

Conventional CT-arthrogram + CBCT arthrogram

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged ≥ 18 years;
  • Patients require CT arthrogram of the ankle;
  • Affiliated to a social security schema;
  • Informed consent signed by patients.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radiological department, Raymond Poincaré hospital, APHP

Garches, 92380, France

Location

Related Publications (4)

  • 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.

    PMID: 33713874BACKGROUND

  • 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.

    PMID: 33280057BACKGROUND

  • 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.

    PMID: 33798932BACKGROUND

  • 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.

    PMID: 30498800BACKGROUND

Study Officials

  • Mickael TORDJMAN, MD

    Radiological department - Raymond Poincaré hospital - APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2021

First Posted

January 24, 2022

Study Start

February 15, 2022

Primary Completion

August 15, 2023

Study Completion

August 15, 2023

Last Updated

May 16, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)