To compare the functional outcome of ORIF with a volar locking plate to closed reduction and plaster immobilisation in patients with dislocated extra-articular distal radius fractures.
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Disability Arm Shoulder Hand Score (DASH)
Secondary outcome
Patient-Rated Wrist Evaluation score (PRWE), quality of life (QoL SF-36), pain
as indicated on a Visual Analogue Scale (VAS), Range of Motion (ROM),
radiological outcome and complications, costs and absence from work.
Background summary
The ideal treatment for patients with dislocated extra-articular distal radius
fractures remains a controversial issue. Excellent results have been described
both in patients treated with a plaster and in patients treated with open
reposition and internal fixation (ORIF) with a volar locking plate. Recently,
the use of Volar Locking Plates has become more popular, due to its better
performance in osteoporotic bone. Moreover, anatomic reduction and stable
fixation of these fractures allows for early mobilization and may theoretically
lead to a better function.
Study objective
To compare the functional outcome of ORIF with a volar locking plate to closed
reduction and plaster immobilisation in patients with dislocated
extra-articular distal radius fractures.
Study design
Randomized Controlled Trial
Intervention
This study will randomise between open reduction and internal fixation with a
volar locking plate and plaster immobilisation.
Study burden and risks
The treatment that patients will receive is a component of the standard
treatment of care which currently depends on the surgeon*s preference and the
complexity of the fracture. Patients will be asked to return to the hospital
for follow up at one, three and six weeks, three months, six months and at
twelve months. All visits are part of standard care following a fracture
treated in this hospital. During these visits, patients will be asked about any
complaints and/or complications and physical examination will be performed. The
assessment of the range of motion of the wrist will take approximately five
minutes. Additional to standard care, patients will be asked to fill out four
questionnaires at six weeks, three months, six months and one year. Patients
will be asked to fill out a DASH form, rate their pain on a Visual Analogue
Scale and give an estimation of the type and quantity of pain medication taken
during all visits. This will take approximately ten minutes of their time. The
two other questionnaires: the PRWE score and the SF-36 will approximately take
another ten minutes each. Additionally, a questionnaire on any expenses and
absence from work will me administered. This will take another twenty minutes.
Subjects could experience mild discomfort during physical examination and
testing, but this will be no different from physical examination during routine
follow-up. X-rays will be taken during every visit of which only the final
radiographs at one year are additional to standard care. The burden experienced
regarding time spent is difficult to estimate but will most likely not exceed
30 minutes. In the total duration of this study, patients will spend an
approximate 230 minutes extra.
The risks are comparable to those that the standard treatment involves. This
comprises the standard risk for undergoing a surgical procedure, including
risks related to anesthesia, neurovascular damage and post-operative wound
infection. The risks of plaster immobilization include redislocation, malunion,
loss of function and complex regional pain syndrome. Close follow up and a
protocol of treatment, identical to the standard one, will be applied in every
subject. Reduction of risks will be done according to inclusion and exclusion
criteria. If complications arise, the treating physician will proportionate the
adequate treatment according to the current protocols of treatment based on
published literature.
Patients who are treated with volar plate fixation are expected to achieve
better results regarding mobility and recovery of wrist function.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
diagnosed with a dislocated extra-articular distal radius fracture
Exclusion criteria
· Patients with impaired wrist function prior to injury due to arthrosis/neurological disorders of the upper limb.
· Open distal radius fractures
· Multiple trauma patients
· Other fractures in the affected extremity
· Insufficient comprehension of the Dutch language to understand a rehabilitation program and other treatment information as judged by the attending physician.
· Patient suffering from disorders of bone metabolism other than osteoporosis (i.e. Paget*s disease, renal osteodystrophy, osteomalacia)
· Patients suffering from connective tissue disease or (joint) hyperflexibility disorders such as Marfan*s, Ehler Danlos or other related disorders.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL37754.018.12 |
| OMON | NL-OMON26639 |