To assess the performance of a distal radius osteotomy supported by 3D guides in patients suffering from a radius malunion by comparing the pre-planned radius correction to the actual correction derived from a postoperative CT.
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the performance of distal radius osteotomies, two 3D angles are
generated. One 3D angle is generated between the preoperative and the planned
orientation and one between the preoperative and postoperative orientation.
These 3D angles will be used to find the coherence between the planning and the
operative result which will be statistically tested using a non-inferiority
margin. These results will be compared to patient related outcome measures to
find the coherence between surgical result and patient satisfaction. This
coherence will be tested using a Pearson correlation (normal distribution) or
Spearman correlation (non-normal distribution).
Secondary outcome
-
Background summary
Distal radius fractures resulting in a malunion after initial treatment have an
incidence of 5-6.5 per 10,000 person-years. Historically, two perpendicular
X-ray images have been used to assess the severity of these malunions. Based on
these X-ray images, the decision to operate and the degree of correction were
determined. Research then showed that X-ray was unable to assess the axial
rotation component in radius malunions which was the cause for suboptimal
surgical corrections. Since CT is capable of 3D assessment, it was introduced
for assessment of radius malunions and planning of radius osteotomies. Since
the last decade, these CT scans have been used to create surgical guides which
translate the planned correction to the operating room.
The operative result is currently still evaluated using two perpendicular X-ray
images although research has shown this not to suffice in proper evaluation of
radius malunions. This study aims to objectively evaluate the surgical result
after surgery using surgical guides by obtaining a CT scan postoperatively for
3D evaluation.
Study objective
To assess the performance of a distal radius osteotomy supported by 3D guides
in patients suffering from a radius malunion by comparing the pre-planned
radius correction to the actual correction derived from a postoperative CT.
Study design
A cohort study consisting of 20 patients.
Study burden and risks
Additional to the regular care, a postoperative CT of both forearms is needed
to perform this research. The CT scan, which takes approximately 10-15 minutes
of the patient*s time, will be planned on the day the patient visits the clinic
for regular follow-up. The CT has a dose of 0.029 mSv which corresponds to 2%
of the annual Dutch background radiation. There is no expected risk associated
with participation in this research. Participation in this research has no
consequences for the regular care of the patient.
Geerdinksweg 141
Hengelo 7555DL
NL
Geerdinksweg 141
Hengelo 7555DL
NL
Listed location countries
Age
Inclusion criteria
The patient will undergo/underwent distal radius correction osteotomy surgery
with the use of PSGs designed in OCON Centre of Orthopaedic Surgery.
Exclusion criteria
The patient has a contraindication for CT scans.
Design
Recruitment
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 | NL74563.100.20 |