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

4 Dimensional - Impairment of Posttraumatic Forearm Rotation Evaluated With Computed Tomography : 4D-IRECT Pilot Trial

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.

Study Overview

• Status: Completed
• Conditions: Pronation-Supination of the Forearm, Impairment of
• Intervention / Treatment: Diagnostic test: 4D-CT-scan

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France
    • CHU Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with posttraumatic forearm impairment; All patients with a one-sided posttraumatic impairment of forearm pro- and/or supination at least 3 months after injury	Diagnostic test: 4D-CT-scan; Both forearms of the subjects with posttraumatic forearm impairment are scanned with a 4D-CT scanning technique, during forearm rotation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantification of forearm motion patterns	Calculate the mean and standard deviation of the healthy versus the affected forearm rotation.	the 4D-CT-scan procedure

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Geert BUIJZE, MD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2020
• Primary Completion (Actual): June 15, 2020
• Study Completion (Actual): June 15, 2020

Study Registration Dates

• First Submitted: August 21, 2019
• First Submitted That Met QC Criteria: August 21, 2019
• First Posted (Actual): August 26, 2019

Study Record Updates

• Last Update Posted (Actual): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Four Dimensional Computed Tomography (4D-CT)
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Movement Disorders
• Other Study ID Numbers: RECHMPL18_0463; UF 7729 (Other Identifier: Sponsor)

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