The effectiveness of surgery versus casting for elderly patients with Displaced inta-Articular distal Radius fractures. A randomized controlled Trial.

It is unclear how intra-articular fractures in elderly patients should be
treated. To ensure optimal functional outcome there is a tendency to operate.
However, there is no evidence that supports the surgical treatment of patients
65 years and older and in the absence of clinical trials it stays unclear how
patients >65 with intra-articular fractures should be treated.

Assessing the (cost)-effectiveness of operative treatment compared with
non-operative treatment for elderly patients with an intra-articular distal
radius fractures.

Multi-Centre randomized controlled trial with a non-inferiority design.
Economic evaluation alongside a randomized controlled multi-center trial.

Patients will be randomized between surgery (open reduction internal fixation)
or conservative treatment (casting).

The treatment that study participant receive is a component of standard
treatment of care. Prior research suggests there is no difference in long-term
function between both treatment groups. Currently the choice of treatment is
based on the preference of the surgeon, the complexity of the fracture and the
national guideline for the treatment of radius fractures.
Post-operatively or after cast therapy patients will be seen after 1 week, 3
weeks, 6 weeks, 3 months, 6 months and 12 months. These visits are standard
care for patients following a fracture. In all these visits patients will be
asked about complaints or complications, which is also part of regular care.
At baseline and after 6 weeks, 3 months, 6 months and 12 months patients will
be asked to fill out 6 questionnaires mentioned earlier as the main study
parameters. These questionnaires can be filled out at home online or in the
hospital prior to their visit and will take approximately 30 minutes for each
of these data collection moments.
In total study participants will spend 210 minutes to this study. This includes
informed consent.
The risks of this study are comparable to risks involved with standard
treatment. 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.
Possible complications will be treated according to standard protocol.