Operative Treatment of Intra-Articular Distal Radius Fractures With versus Without Arthroscopy
a Randomized Controlled Trial

The past several years an increase in open reposition internal fixation (ORIF)
for distal radius fractures has been observed. This technique leads to a
quicker resume of function the first 3 to 6 months compared to non-operative
treatment. However, some patients with a dislocated intra-articular distal
radius fracture continue to have a painful and stiff wrist postoperatively.
Arthroscopically assisted removal of intra-articular fracture haematoma and
debris may improve the functional outcomes following operative treatment of
intra-articular distal radius fractures. Moreover, during arthroscopy the
quality of the reduction and the presence of associated ligamentous injuries
can be assessed.

The objective of this randomized controlled trial is to determine the
difference in functional outcome, assessed with the Patient-Rated Wrist
Evaluation Score (PRWE), after conventional fluoroscopically assisted plate
fixation and plate fixation with an additional arthroscopy in adult patients
with displaced intra-articular distal radius fractures.

(singlecenter) Randomized controlled trial.

This study will randomize between a conventional fluoroscopic open reduction
and internal volar plate fixation (control group) and the conventional
procedure with an additional wrist arthroscopy (intervention group).

The treatment that patients will receive is a component of the standard
treatment of care, which currently depends on the surgeon*s preference.
Patients will be asked to return to the hospital for follow up at one, three
and six weeks and three months. All visits are part of standard care following
a fracture treated in this hospital. Additionally patients are phoned 1 day
post-operative to ask about post-operative pain. During the 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 three and six weeks
and three months. Patients will be asked to fill out a PRWE and 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 fifteen minutes of their time. Additionally, a questionnaire on
any expenses and absence from work will be administered. This will take another
ten minutes. Subjects could experience mild discomfort during physical
examination and testing, but this will be no different from physical
examination during routine follow-up. 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 90 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. Patients undergoing an arthroscopic assisted procedure will have a
longer duration of the operation time, about 40 minutes. Possible complications
of wrist arthroscopy include infection, articular surface damage, injury of one
of the nerves and tendon rupture. Nevertheless, wrist arthroscopy is a
well-established and safe technique. 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.