Aneurysmal Bone Cyst Imaging After Interventional Radiology Treatment (KOA-RI)

September 29, 2021 updated by: University Hospital, Montpellier

Aneurysmal Bone Cyst Imaging After Interventional Radiology Treatment: Clinical and Radiological Outcome

This study aims to describe the clinical outcomeand the radiological appearance of aneurysmal bone cyst treated by means of interventional radiology procedures (percutaneous sclerosis and endovascular embolization)

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

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
      • Montpellier, France, 34295
        • Uhmontpellier

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

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Aneurysmal bone cyst

Description

Inclusion criteria:

  • Male of female
  • Aging from 0 to 30 years
  • With typical aneurysmal bone cyst at initial imaging
  • At least one interventional radiology procedure performed

Exclusion criteria:

  • No initial surgery
  • Patient refuses to participate

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Aneurysmal bone cyst
Patient aging from 0 to 30 years with diagnosis of aneurysmal bone cyst treated by percutaneous alcolisation or endovascular embolization.
Other: radiology
Interventional radiology for aneurysmal bone cyst ( percutaneous alcoholization, vascualr embolisation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of size lesion after treatement
Time Frame: day 1

Percentage of peripheral reossification after treatment :

  • 0%: no reossification
  • < 25%: low reossification
  • Between 25% -50%: Partial reossification
  • Between 50-75%: significant reossification
  • > 75%: very significant reossification
  • 100%: complete reossifcation
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of pain
Time Frame: day 1
Pain measured with Pain scale ( 0 = no pain , 10 = maximum pain)
day 1
number of deficience
Time Frame: day 1
Number of patients needs second treatment 3- Fracture ? (yes or no)
day 1
number of complication
Time Frame: day 1
Fracture ? (yes or no)
day 1

Collaborators and Investigators

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

Sponsor

University Hospital, Montpellier

Investigators

  • Study Director: Catherine CYTEVAL, MD.PhD, University Hospital, Montpellier

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)

January 1, 2021

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

March 30, 2022

Study Registration Dates

First Submitted

July 5, 2021

First Submitted That Met QC Criteria

September 29, 2021

First Posted (Actual)

October 12, 2021

Study Record Updates

Last Update Posted (Actual)

October 12, 2021

Last Update Submitted That Met QC Criteria

September 29, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL21_0029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

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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