To investigate clinical outcome, functional outcome and accuracy of patient-tailored plating in corrective osteotomy procedures and compare this to the standard osteotomy procedures based on 2D imaging and standard fixation plates. Additionally we…
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Functional outcome of the wrist is assessed through physical examination,
measuring: flexion, extension, pronation, supination, radial deviation and
ulnar deviation.
Secondary outcome
Accuracy is calculated using computed tomography imaging, providing us with:
dorsal collapse, radial collapse and rotational deformation.
Total costs are assessed using direct medical costs, operation time, indirect
costs (aftercare) and workplace absenteeism. Self-assessed quality-of-life is
assessed using the EuroQol EQ-5D-5L questionnaire.irect medical costs,
operation time, indirect costs (aftercare), workplace absenteeism,
self-assessed quality-of-life (using EuroQol EQ-5D-5L questionnaire).
Other study parameters: age, gender, body weight, smoking, alcohol, diabetes,
NSAID usage.
Background summary
Distal radius fractures are among the most common types of fractures,
accounting for 25% of pediatric fractures and up to 18% of fractures in elderly
persons. Usually, the mechanism of injury is a fall on the outstretched arm
from standing position. Complications include malunion of the distal radius,
occurring in approximately 5% of patients with complaints of significant pain,
deformity and decreased functional ranges of motion.
Treatment of malunited distal radial fractures is centered on accurately
re-establishing normal anatomy, especially since the precision of the
realignment has shown to be significantly associated with better functional
outcomes. In order to provide stable fixation following osteotomy, surgeons use
anatomical plates, pre-shaped to optimally fit the contour of the undeformed
distal radius.
In malunion cases, however, the bone is generally deformed. Using a standard
fixation plate in these cases may result in substantial residual positioning
errors and reduced functional outcome. Novel techniques describe the use of
preoperative 3D imaging to design patient-tailored fixation plates, fitting the
bone geometry more precisely and resulting in accurate restoration of bone
alignment.
To further investigate the potential benefits of this new technique, it is
necessary to analyze the results in a larger group of patients. Additionally,
this provides a unique opportunity to compare using custom fixation plates with
conventional anatomical plates.
Study objective
To investigate clinical outcome, functional outcome and accuracy of
patient-tailored plating in corrective osteotomy procedures and compare this to
the standard osteotomy procedures based on 2D imaging and standard fixation
plates. Additionally we will investigate cost and quality-of-life differences
between the new and old technique.
Study design
Randomised controlled trial, single-blinded, to study the difference between
3D-printed patient-tailored plating and default anatomical plating.
Intervention
One group (n=24) will undergo a corrective osteotomy procedure, in which
standard anatomical plating will be used for bone fixation. The other group
(n=24) will undergo corrective osteotomy using patient-tailored plating,
printed three-dimensionally to optimally fit the bone contour. All participants
will undergo computed tomography (CT) scans of the wrist both pre-operatively
and 6 months after the surgical procedure.
Study burden and risks
not applicable
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Patients are adults aged 18 years or over with a symptomatic malunion after distal radius fracture.
Exclusion criteria
- Bony deformities in the contralateral distal forearm.
- Congenital skeletal disorders (Madelung deformity).
- Not able to understand the written informed consent.
- Pregnancy.
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 | NL56144.018.16 |