Pronation-Supination of the Forearm, Impairment of4D-IRECTNCT04067232
4 Dimensional - Impairment of Posttraumatic Forearm Rotation Evaluated With Computed Tomography
A study testing 4D-CT-scan in people with Pronation-Supination of the Forearm, Impairment of, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pronation-Supination of the Forearm, Impairment of
- What is being tested?
- 4D-CT-scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jan 2020to 15 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- 4D-CT-scan
- Keywords
- Four Dimensional Computed Tomography (4D-CT)
- Medical subject headings
- Pronation-Supination Of The Forearm, Impairment Of
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4D-CT-scanDiagnostic test
Both forearms of the subjects with posttraumatic forearm impairment are scanned with a 4D-CT scanning technique, during forearm rotation.
| Study group | Role | What they receive |
|---|---|---|
| Patients with posttraumatic forearm impairment | Experimental | All patients with a one-sided posttraumatic impairment of forearm pro- and/or supination at least 3 months after injury Receives: Diagnostic Test: 4D-CT-scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of forearm motion patterns
Calculate the mean and standard deviation of the healthy versus the affected forearm rotation.
Measured: the 4D-CT-scan procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start16 Jan 2020
- Primary completion15 Jun 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pronation-Supination of the Forearm, Impairment ofStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geert BUIJZE, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067232
- Sponsor's protocol ID
- RECHMPL18_0463
- Other IDs
- UF 7729
- Acronym
- 4D-IRECT
- Status last verified
- Sep 2020
- First submitted
- 21 Aug 2019
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4 Dimensional - Impairment of Posttraumatic Forearm Rotation Evaluated With Computed Tomography : 4D-IRECT Pilot Trial
- ClinicalTrials.gov ID
- NCT04067232
- Acronym / sponsor ID
- 4D-IRECT / RECHMPL18_0463
- Keywords
- Four Dimensional Computed Tomography (4D-CT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 26 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with posttraumatic forearm impairment | Experimental | Diagnostic Test: 4D-CT-scanAll patients with a one-sided posttraumatic impairment of forearm pro- and/or supination at least 3 months after injury |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4D-CT-scanBoth forearms of the subjects with posttraumatic forearm impairment are scanned with a 4D-CT scanning technique, during forearm rotation. | Diagnostic test | Patients with posttraumatic forearm impairment |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geert BUIJZE, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4D-CT-scan in people with Pronation-Supination of the Forearm, Impairment of, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of forearm motion patterns (time frame: the 4D-CT-scan procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022; AzTrials last refreshed its copy on 3 Nov 2026.