The aim of this study is to investigate whether a minimally-invasive stepwise treatment leads to sufficient improvement of forearm rotation in patients with malunion after fracture of the radius and/or ulna.
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postoperative improvement in pronation and supination.
Secondary outcome
Postoperative improvement in subjectively experienced limitations.
Postoperative reduction of pain.
Postoperative improvement of cosmetics.
Postoperative satisfaction.
Background summary
A fracture of the forearm (radius and/or ulna) is one of the most common
fractures in children. Fractures with significant displacement are
repositioned, and all fractures are stabilised with pins and/or cast to achieve
fracture healing. In 30% of children treated with cast only, secondary
displacement of the fracture occurs. If this displacement is not corrected, a
malunited fracture occurs.
A malunion can cause functional impairment in addition to pain and cosmetic
complaints. In many cases, this limitation consists of no longer being able to
(fully) rotate the forearm, which can cause much discomfort in daily life.
The standard treatment is a corrective osteotomy of both the radius and ulna
using three-dimensional printed patient-specific guides to correct the
alignment of the bones. This is a major procedure involving a lengthy
rehabilitation period and large scars. Using four-dimensional techniques, we
can now better predict what causes the rotational restriction: too-tight soft
tissue or bone impingement. In the case of too-tight soft tissue (central
ligament between radius and ulna), it may be sufficient to cut this ligament,
while in the case of bone impingement, it may not always be necessary to
correct both bones. Because restoration of function is more critical for a
patient than the restoration of the exact pre-traumatic anatomy, in this study,
we will make an individual treatment plan for each patient that is as minimally
invasive as possible. This is the minimally invasive stepwise treatment. As an
escape, a peroperative two-bone corrective osteotomy with patient-specific
guides can always be performed, which is the standard treatment.
Study objective
The aim of this study is to investigate whether a minimally-invasive stepwise
treatment leads to sufficient improvement of forearm rotation in patients with
malunion after fracture of the radius and/or ulna.
Study design
Prospective pilot study with a one year follow-up
Intervention
Patients are treated using a minimally-invasive stepwise treatment.
Study burden and risks
Patients will have the standard risks associated with surgery. They will also
have radiation exposure from the X-rays (pre- and postoperative) and the CT
scans.
The extra load for patients participating in the study in comparison to
patients not participating are:
-An additional CT scan 1 year postoperatively (extra radiation 0.4 mSv).
-Time load for filling in the questionnaires at 4 timepoints and physical
examinations.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
Malunion after radius and/or ulna fracture
Less than 50 degrees of pronation and/or supination
Complaints of the forearm
Full consolidation of the fractures
Informed consent for participation in the study
Exclusion criteria
Relevant deviations of the contralateral arm
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 |
---|---|
Other | NL6324 en NL8059 |
CCMO | NL85062.078.24 |