Is the present malrotation of the tibia, 15 degrees exorotation and 10 degrees endorotation, after intramedullary nailing acceptabel. Furthermore, we want to know which technique could reduce the possible malalignment in patients. In present there…
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A validated and acceptated limit in rotational malalignment.
Secondary outcome
* incidence of malrotation
* correlation between the amount of malrotation and the presence of knee or
ankle arthritis and clinical experience
* validated and reliable clinical assessment compared with CT measurement
* malrotation between both oepration techniques
Background summary
When patients with a cruris fracture are treated with intramedullaire nailing
it is possible that a rotational malalignment could occur. Rotational
malaligment could lead to earlier onset of osteoarthritis on long term. On
short term patellofemoral complaints and gait changes are possible. The
incidence of rotational malalignment is unknown and this is partly due to the
fact that there is no consensus in the deviation that is acceptable for
patients.
Study objective
Is the present malrotation of the tibia, 15 degrees exorotation and 10 degrees
endorotation, after intramedullary nailing acceptabel. Furthermore, we want to
know which technique could reduce the possible malalignment in patients. In
present there are two standard techniques used during operation; free hand
technique and the fixation technique.
Study design
The research is divided in two parts; retrospective long term follow-up study
and a prospective, randomised study to compare the two oepration techniques.
ROMIO I (retrospective):
CT-scan, questionnaires and clinical evaluation
The clinical evaluation will be done by three observers at several time points.
With this procedure we can also evaluate the intra- and interobserver
variation.
ROMIO II (prospective):
randomisation in free hand technique or extension/traction table technique
The follow-up of patients will be done on standard time points, with a
complementary CT-scan at 3 months postoperative. During these follow-up moments
questionnaires and clinical evaluation will be done by each patient.
Intervention
The ROMIO II group has an intervention in terms of operation technique. The
differences in the group are pending on the so called 'free hand' technique and
extension/traction technique.
Study burden and risks
Patients in the ROMIO I part will have to visit the clinic again, becasue
standard follow-up is already ended.
ROMIO II patients have no advantage and disadvantage of participation in the
study. A extra CT scan is the extra burden that will be done at 3 months
postoperative.
Lijnbaan 32
2501 CK Den Haag
Nederland
Lijnbaan 32
2501 CK Den Haag
Nederland
Listed location countries
Age
Inclusion criteria
- crurisfracture where operative treatment is necessary with a UTN
- age > 18 years
Exclusion criteria
- Multi trauma, wit h more fractures such as
ipsilaterl pilon fracture
lateral or medial malleolus fracture
syndesmose rupture
- reumatic arthritis
- poly arthritis
- no dutch language mastered
- pregnancy or desired to be pregnant
Design
Recruitment
metc-ldd@lumc.nl
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 | NL23628.098.08 |