Evaluating the utility of bone grafts in open wedge corrective osteotomy and plate fixation in patients with malunited distal radius fractures (WOPPeR trial)

Malunion is the most common complication of distal radius fractures and is
associated with increased pain, weakness, decreased range of motion, and/or
neurologic symptoms. These symptoms can have a great impact in daily
activities. Many surgical techniques have been described for the correction of
the radial deformity, but open wedge osteotomy with plate fixation and bone
grafting from the iliac crest is considered as the standard procedure. This
technique effectively restores the length of the radius, but it also creates a
void. A variety of bone grafts and substitutes are available for filling that
void, but the harvesting of bone from the iliac crest is the gold standard as
it allows easy access to corticocancellous bone of a desirable quality and
quantity. The idea behind bone grafting is to provide optimal bone formation
and structural stability, which is crucial for bone healing. Biomedical
studies, however, have shown that the current design of the plate and screws
provides good structural stability in itself. Further, the harvesting and use
of bone from the iliac crest come with the risk of complications, with reported
complication rates between 2.8% and 39%. The following complications are
reported: delayed union; size mismatch between the graft and the osteotomy
defect; longer operation times; donor site morbidity, including nerve,
arterial, and ureteral injury; herniation of abdominal contents; sacroiliac
joint instability; pelvic fractures; hematoma; and infection. Up to 49% of
patients complain of pain around the iliac crest, which can persist for several
years. This pain is often reported as more severe than the pain at the primary
surgical site. The complications associated with harvesting bone from the iliac
crest can adversely affect patients* quality of life, leading to more
reinterventions, longer hospital stays and greater reliance on pain medication.

To date, there is no consensus in literature on the harvest and use of bone
from the iliac crest during corrective osteotomy and plate fixation of the
distal radius. We are not aware of any randomized, controlled studies comparing
the standard treatment with the intervention. The standard treatment is
extensively described in literature. However, several retrospective studies
have evaluated various outcomes after open wedge corrective osteotomy and plate
fixation without bone grafting. These studies showed no relevant differences in
incidence of bone healing problems compared to studies which used the standard
treatment. These studies evaluated bone healing using standard radiographs with
limited resolution, meaning the bone healing process could not be followed in
detail. A CT scanner enables more precise detection of early fracture healing
than radiographs. There is no data available regarding to cost-effectiveness.


As the disadvantages of bone grafting can have a major impact on patients*
everyday lives, research is needed on whether bone grafting is genuinely
necessary during corrective osteotomy and plate fixation of the distal radius.
If there is no difference in bone healing and functional outcomes between the
standard treatment and the intervention, there is no reason to subject patients
to harvesting bone from the iliac crest and they will be no longer exposed to
the associated complications. This will result in reducing costs by avoiding
the complications associated with the harvest and use of bone from the iliac
crest. The findings will also be relevant for corrective osteotomy in other
metaphyseal bone areas, where bone grafting from the iliac crest is also the
standard treatment, yet no consensus exists on whether it is necessary.

Primary objectives are:
1. Are there differences in complication rates between patients treated with
harvesting of bone from the iliac crest and patients not treated with bone
grafting during open wedge corrective osteotomy and plate fixation of the
distal radius?

2. Will patients not treated with bone grafting have a better quality of life
compared to patients treated with harvesting of bone from the iliac crest
during open wedge corrective osteotomy and plate fixation of the distal radius?

3. Are there differences in time to complete bone healing between patients
treated with harvesting of bone from the iliac crest and patients not treated
with bone grafting during open wedge corrective osteotomy and plate fixation of
the distal radius?

Secondary objectives are:
1. Are there differences in subjective and objective functional outcomes
between patients treated with harvesting of bone from the iliac crest and
patients not treated with bone grafting during open wedge corrective osteotomy
and plate fixation of the distal radius?

2. Is open wedge corrective osteotomy and plate fixation without bone grafting
cost effective compared to the standard treatment with harvesting of bone from
the iliac crest in patients with malunited distal radius fractures?

This is a prospective, randomized, controlled multicenter study involving the
following hospitals: Maastricht University Medical Centre (MUMC+), Academic
Medical Centre (AMC), VieCuri Medical Centre, Zuyderland Medical
Centre,Elkerliek Hospital, Erasmus Medical Centre and Amphia Hospital. The
follow-up period is at least 1 year and includes 5 postoperative visits. During
the visits, the patients will undergo several examinations: filling out
questionnaires, undergoing physical examination and making radiographs and CT
scans. This study will take at least 4 years taking into account that
approximately 35 patients will be operated per year.

All included patients will undergo an open wedge osteotomy and plate fixation
according to the standard surgical techniques. In one group, the bone defect
will be filled with bone graft of the iliac crest after open wedge osteotomy
according the standard procedure. The other group includes patients who will
not receive any bone grafts. All participating hospitals have extensive
experience with both treatments. The postoperative care and rehabilitation
protocol will be the same for both groups.

All included patients have to fill out questionnaires and undergo physical
examination of their wrists. Also extra radiographs and CT scans will be made.
The extra radiation exposure in this study will be maximal ~1,01 mSv (CT scans:
5x0,2 mSv = 1 mSv and radiographs: 1x7 µSv = 0,007 mSv). When the osteotomies
in patients show complete bony union on the radiographic imaging, no more
CT-scans will be made in these patients during the follow-up. The radiation
exposure in the standard care is ~0,04 mSv (radiographs: 6x7 µSv). Each visit
at the hospital will take 60 minutes. By participating in this study, patients
will be more intensively monitored and they contributed to better health care.
Also, the patients will have more insight in how scientific research works.