Internal Plate Fixation versus Plaster in Complete Articular Distal Radius Fractures

The ideal treatment for patients with displaced complete articular distal
radius fractures remains a controversial issue. Loss of reduction of a
acceptable reduced fracture is not uncommon. Recently published literature
shows good to excellent results in both patients treated with closed reduction
and plaster immobilization and in patients treated with open reposition and
internal fixation (ORIF) with a plate. However, these studies do not
differentiate between displaced intra- and extra-articular fractures.
Recently, the use of volar locking plates has become more popular, due to its
better performance in osteoporotic bone. Moreover, these plates can be
perfectly combined with dorsal and radial column plates. The anatomic reduction
and stable fixation of these fractures allows for early mobilization and may
theoretically lead to a better function.

To determine the difference in functional outcome between open reduction and
internal platefixation and closed reduction and plaster immobilisation in
patients with displaced complete articular distal radius fractures.

(multicentre) Randomized Controlled Trial

This study will randomise between open reduction and internal platefixation and
closed reduction and plaster immobilisation.

The treatment that patients will receive is a component of the standard
treatment of care, which currently merely depends on the surgeon*s preference,
and the complexity of the fracture and the current National Guidelines for
distal radius fractures. Patients will be asked to return to the hospital for
follow-up at one, two/three and five/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 rate their pain on a Visual Analogue Scale and give an
estimation of the type and quantity of pain medication taken during all visits.
They will also be asked to fill out the PRWE, DASH score and the SF-36 form.
This will take approximately thirty minutes of their time. Additionally, a
questionnaire on any expenses and absence from work will be administered. This
will take another ten minutes. Patients can fill out these four questionnaires
at home online on our website, or in the waiting room before the actual consult
takes place. 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 40 minutes. In the total duration of this study,
patients will spend an approximate 190 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 closed reduction and plaster immobilization include
stiffness, 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 the published literature.