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4 Dimensional - Impairment of Posttraumatic Forearm Rotation Evaluated With Computed Tomography (4D-IRECT)

Primary Purpose

Pronation-Supination of the Forearm, Impairment of

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
4D-CT-scan
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pronation-Supination of the Forearm, Impairment of focused on measuring Four Dimensional Computed Tomography (4D-CT)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with a one-sided posttraumatic impairment of forearm pro- and/or supination at least 3 months after injury
  • Patients are above 18 years
  • Patients who are willing to give informed consent
  • National health insurance cover

Exclusion Criteria:

  • A history of trauma to both forearms
  • Any shoulder pathology or impairment preventing forward elevation of the arm as required during the scanning protocol
  • Neuromuscular pathology
  • Not able to understand or give informed consent
  • Pregnancy (βHCG positive), breast-feeding or the absence of effective contraception for women of child-bearing age
  • Legal incapacity (persons in custody or under guardianship)
  • Deprived of liberty Subject (by judicial or administrative decision)

Sites / Locations

  • CHU Montpellier

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with posttraumatic forearm impairment

Arm Description

All patients with a one-sided posttraumatic impairment of forearm pro- and/or supination at least 3 months after injury

Outcomes

Primary Outcome Measures

Quantification of forearm motion patterns
Calculate the mean and standard deviation of the healthy versus the affected forearm rotation.

Secondary Outcome Measures

Full Information

First Posted
August 21, 2019
Last Updated
December 13, 2022
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT04067232
Brief Title
4 Dimensional - Impairment of Posttraumatic Forearm Rotation Evaluated With Computed Tomography
Acronym
4D-IRECT
Official Title
4 Dimensional - Impairment of Posttraumatic Forearm Rotation Evaluated With Computed Tomography : 4D-IRECT Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 16, 2020 (Actual)
Primary Completion Date
June 15, 2020 (Actual)
Study Completion Date
June 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to develop a 4D-CT (4 Dimensional Computed Tomography) -scan acquisition method for estimating the cause of posttraumatic impairment of the forearm. Both forearms of patients with posttraumatic impairment of one of the forearm will be scanned using a 4D-CT-scan, during forearm rotation. Rotation of impaired and healthy forearms will be analysed and compared to each other. This method is intended to allow differentiation of motion patterns reflecting an osseous impairment from those caused by soft tissue pathology in order to improve treatment choice.
Detailed Description
Forearm and wrist fractures are the most common of all fractures and mostly occur at the distal end of the radius. Distal radius fractures are associated with posttraumatic sequelae, which typically involve restricted forearm rotation. Diagnostics of dynamic traumatic pathologies are conventionally based on static (2D or 3D) imaging protocols using MRI (magnetic resonance imaging) or CT. However, interpretation of indirect suggestive findings - such as edema or abnormal bone positions - limits accuracy and inter-observer reliability. Dynamic 4D imaging (adding the fourth dimension of time) has the potential to discriminate whether forearm rotation deficit is due to an osseous deformity causing bony impingement or whether it is due to non-osseous pathology. Hence it may reduce unnecessary corrective osteotomies and guide the patient and surgeon towards the most effective surgical or conservative treatment choice - expectedly resulting in better outcomes and patient satisfaction. In addition, we aim to develop a classification based on the estimated motion patterns and assess its reliability. Furthermore we aim at acquiring knowledge of physiological mechanics of the radioulnar joint and to assess symmetry in radioulnar joint motions between two healthy forearms on 4D-CT-scans.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pronation-Supination of the Forearm, Impairment of
Keywords
Four Dimensional Computed Tomography (4D-CT)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with posttraumatic forearm impairment
Arm Type
Experimental
Arm Description
All patients with a one-sided posttraumatic impairment of forearm pro- and/or supination at least 3 months after injury
Intervention Type
Diagnostic Test
Intervention Name(s)
4D-CT-scan
Intervention Description
Both forearms of the subjects with posttraumatic forearm impairment are scanned with a 4D-CT scanning technique, during forearm rotation.
Primary Outcome Measure Information:
Title
Quantification of forearm motion patterns
Description
Calculate the mean and standard deviation of the healthy versus the affected forearm rotation.
Time Frame
the 4D-CT-scan procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a one-sided posttraumatic impairment of forearm pro- and/or supination at least 3 months after injury Patients are above 18 years Patients who are willing to give informed consent National health insurance cover Exclusion Criteria: A history of trauma to both forearms Any shoulder pathology or impairment preventing forward elevation of the arm as required during the scanning protocol Neuromuscular pathology Not able to understand or give informed consent Pregnancy (βHCG positive), breast-feeding or the absence of effective contraception for women of child-bearing age Legal incapacity (persons in custody or under guardianship) Deprived of liberty Subject (by judicial or administrative decision)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geert BUIJZE, MD
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Montpellier
City
Montpellier
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

4 Dimensional - Impairment of Posttraumatic Forearm Rotation Evaluated With Computed Tomography

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