The goal of this study will be to determine a functional benefit and an increase in patient satisfaction after a period of one year of open reduction and internal fixation (ORIF) by volar approach versus percutaneous reposition and fixation with…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Functional outcome scores (DASH, MAYO wrist score) and patient satisfaction
score (SF 36), pain score (VAS)
Secondary outcome
Radiological findings, complications
Background summary
Fractures of the distal radius are a frequently seen common clinical problem al
over the world. Almast 4000 distal radius fractures were diagnosed in The
Netherlands in 2005. Because of an expected increase in eldery and the
incidence of osteoporosis, the number of fractures will increase. Almost 60 %
of the distal radius fractures are intra-articular fractures. Many different
treatment options are used.
To avoid late complications like posttraumatic arthritis it is important to
restore the intra-articular surface to its anatomic position, because deformity
leads to a decrease in functionality of the wrist. For the first period after
treatment it is important to choose a treatment option that will give the
patient quick recovery of wrist function. For the instable fracture types a
conservative treatment is not an option and those fractures should become
operative treatment.
At this moment, there is no consensus about the different options of treatment.
Closed reduction and fixation with external fixation shows some good results.
The development of the volar angle stable locking plates a new treatment option
can be used with less postoperative complications. Recovery of the intra
articular deformity will give the fracture elements more stability after
reposition.
These two treatment options have never been compared within a prospective,
randomised controlled trial.
Study objective
The goal of this study will be to determine a functional benefit and an
increase in patient satisfaction after a period of one year of open reduction
and internal fixation (ORIF) by volar approach versus percutaneous reposition
and fixation with external fixation as a treatment of dislocated
intra-articular distal radius fractures
Study design
A multicenter prospective randomised controled trial. Intention to treat.
Intervention
Group A will get a treatment with ORIF (open reposition and internal fixation)
and group B will get an external fixation
Study burden and risks
Both treatment options are already commonly used. Therefore the risks for the
patients will be minimal. After a regular follow-up of 6 months patients come
back for a final visit after one year. physical examination, two x-rays and
scoringsformulars will be filled in.
Lijnbaan 32
2512 VA Den Haag
Nederland
Lijnbaan 32
2512 VA Den Haag
Nederland
Listed location countries
Age
Inclusion criteria
age > 50
informed consent
dutch language
intra-articular fractures type AO B/C and Frykmann III, IV, VII and VIII
closed fractures and open fractures Gustillo gr 1/2
Exclusion criteria
Fractures > 14 days old
Gr 3 Gustillo classification
Pre-existent arthritis of the wrist
ASA IV-V
No informed consent
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 | NL18357.098.07 |