First, to develop a 4D computer-assisted diagnostic method for estimating the cause of posttraumatic impairment of the forearm. This method is intended to allow differentiation of motion patterns reflecting mutual impingement of radius and ulna from…
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
As an uninjured radius normally rotates +/- 180 degrees around the ulna at the
distal radioulnar joint (DRUJ), the aim is to estimate the pattern of
restricted motion of the posttraumatic (malunited) radius relative to the ulna,
expressed in rotation at the level of the DRUJ. The main endpoint is to study
whether we can differentiate between osseous (impinged) versus non-osseous
(non-impinged) motion patterns as origin of restricted forearm rotation.
Secondary outcome
Based on the patterns in inter-relational radioulnar motion pattern, the
secondary aim is to develop a 4D classification tool for posttraumatic
impairment of the forearm and to assess its inter- and intra-observer
reliability. Futhermore to assess physiological mechanics of the radioulnar
joint and symmetry in motion patterns between two healthy forearms on 4D CT
scans.
Background summary
Radius fractures are associated with posttraumatic sequelae such as symptomatic
malunion in 5% (NL:3,400/year) leading to persistent symptoms of pain, loss of
function and posttraumatic wrist arthritis. Typical posttraumatic impairment
related to malunion involves restricted forearm rotation, which is a pathology
of forearm *dynamics*. In the absence of imaging techniques that can visualize
the true dynamic behaviour of the forearm in 3D, conventional imaging
techniques are used. These conventional techniques, such as radiography (2D),
or MRI or CT (3D), take a snapshot in which the cause of the dynamic pathology
is rarely seen. The physician therefore has to rely on indirect suggestive
findings that coexist with the underlying dynamic restrictions, such as edema
or abnormal bone configurations. Dynamic 3D imaging, or 4D imaging (in which
time is added as the fourth dimension), has the potential to visualize and
quantify forearm motion in 3D. It enables to diagnose if restricted forearm
motion is related to bone deformity caused by the malunion, resulting in
osseous impingement, or due to rupture or adhesions, resulting in deviating
motion patterns without impingement. 4D imaging is therefore expected to make
the difference in objectively diagnosing dynamic pathologies!
The proposed study aims at shifting the paradigm of using static 2D/3D
musculoskeletal imaging to 4D imaging, and to bring dynamic assessment to the
clinic. It enables more specific diagnosis and treatment decision for dynamic
pathologies in the complex field of reconstructive surgery of the forearm.
Study objective
First, to develop a 4D computer-assisted diagnostic method for estimating the
cause of posttraumatic impairment of the forearm. This method is intended to
allow differentiation of motion patterns reflecting mutual impingement of
radius and ulna from those caused by soft tissue pathology. Secondly, to
develop a classification tool based on the estimated motion patterns and assess
its reliability.
Study design
Observational pilot study
Study burden and risks
The radiation exposure is within the category IIa (0,1 - 1 mSv) of the
International Commission on Radiological Protection (ICRP), which qualifies as:
minor risk. Findings from 4D-CT scans will be used for a better decision making
for future patients with posttraumatic impairment of the forearm. While
radiation exposure does not allow unlimitedly forearm imaging, due to the
absence of organs in limbs, radiation risks are extremely low. As motion is
guided voluntary, there is no risk of harm either.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Subjects with posttraumatic forearm impairment:
- Patients with a one-sided posttraumatic impairment of forearm pro- and/or
supination
- Patients are over the age of 16 years
- Patients who are willing to give informed consent, Subjects without
posttraumatic forearm impairment:
- Subjects are over the age of 16 years and
- Subjects who are willing to give informed consent
Exclusion criteria
Subjects with posttraumatic forearm impairment:
- A history of trauma to both forearms and/or
- Not able to understand or give informed consent and/or
- Pregnancy, Subjects without posttraumatic forearm impairment:
- A history of trauma to one or both forearm(s)
- Not able to understand or give informed consent
- Pregnancy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL64090.018.17 |