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Completed

NCT Number: NCT04067232

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Montpellier

Montpellier, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

4D-CT-scan

Diagnostic Test

Both forearms of the subjects with posttraumatic forearm impairment are scanned with a 4D-CT scanning technique, during forearm rotation.

Primary outcomes

  1. Quantification of forearm motion patterns

    Time frame: the 4D-CT-scan procedure

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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: 4D-IRECT

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 26, 2019
Registry last updated
Dec 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.