The (cost-)effectiveness of dynamic bracing versus standard care alone in patients suffering from osteoporotic vertebral compression fractures

OVCFs are the most common fractures among the elderly causing pain and long
term morbidity. After an incident OVCF there is a 20% risk of an additional
fracture in the next year. After a fracture, the disproportionate height loss
from the anterior vertebral body results in wedging. Wedge accumulation over
multiple thoracolumbar levels may lead to subsequent spinal deformity
(vertebral fracture cascade). Spinal deformity has a profound impact on health,
such as physical and pulmonary function, pain and disability, postural control,
and mortality. Treatment of OVCFs should aim to break the downward spiral of
recurrent fractures and to prevent the subsequent progression of global
sagittal malalignment. Furthermore, it should intend to prevent or slow down
the decline in postural control, thereby limiting the increased risk of falling
in these frail patients.

Treatment generally includes a mix of analgesics, preventive osteoporosis
medication and physical therapy (Richtlijn Osteoporose en Fractuurpreventie).
However, for many patients current conservative treatment fails to provide
adequate relief of pain and disability, nor does it prevent subsequent spinal
deformity to end the vicious cycle of the vertebral fracture cascade.

Prevention of an increased anterior bending moment on the trunk is of high
clinical importance to minimize overload on the anterior part of the spine
(vertebral bodies) and thus to prevent new vertebral fractures. As was shown in
our pilot study, six weeks of continuous bracing resulted in a more upright
posture (i.e. decrease in anterior bending moment). This is clinically relevant
since even a small increase in thoracic kyphosis results in a significant rise
in vertebral compressive loading, and in an earlier study we found that a
greater kyphosis angle is independently associated with increased risk of
incident OVCFs.

We therefore hypothesize that dynamic bracing improves sagittal alignment and
thereby decreases the risk of novel vertebral fractures. Currently, the use of
conventional, rigid spinal orthoses is extremely limited in patients suffering
from osteoporosis due to the suspected subsequent atrophy of the trunk muscles
and restricted respiration leading to low patient compliance. The dynamic
orthosis has been developed as an alternative to the standard three-point
orthosis, aiming to overcome the disadvantages of a rigid brace. It shares the
same biomechanical principle of the rigid three-point support, however with a
less rigid immobilization and a dynamic behaviour allowing biofeedback
activation of the dorsal lumbar musculature. In a comparative study, patients
with a dynamic orthosis had more reduction in pain and a greater improvement in
quality of life and respiratory function, with equal effectiveness in
stabilizing the fracture, and fewer complications (39% versus 12%).

Since OVCFs are an increasing health problem with serious clinical
consequences, high-quality studies on the management of OVCFs are warranted. A
large, RCT to determine whether dynamic bracing is (cost)-effective for
patients is a necessity to fill the gap in the conservative treatment of OVCFs.
The results of such a trial are important for both patients and treating
physicians (general practitioners, orthopaedic surgeons, trauma surgeons,
internal medicine specialists, rheumatologists, and physical therapists) who
are consulted by OVCF patients, and currently have no treatment options for
pain and disability except for pain medication.

1. Effect evaluation
To assess the effectiveness of dynamic bracing on quality of life in patients
suffering from an osteoporotic vertebral compression fracture (OVCF).
2. Economic evaluation
To examine whether dynamic bracing compared to standard care alone in patients
suffering from OVCFs is preferable in terms of costs, effects and utilities
from a societal perspective.
3. Process evaluation
To assess the feasibility of dynamic bracing, with the aim of analysing the
extent to which it was performed according to protocol, the attendance and
adherence of patients, and the opinion of patients, their relatives and care
professionals.

In this Dutch, prospective, multicenter randomized controlled trial two methods
of conservative treatment for patients suffering an OVCF will be compared. The
control group will receive usual care, whereas the intervention group will
receive usual care combined with a dynamic semi-rigid thoracolumbar orthosis.
The study will consist of three parts (a clinical effectiveness evaluation, an
economic evaluation and a process evaluation), each with its own objectives and
research questions.

INTERVENTION: A dynamic thoracolumbar orthosis, the Spinova Osteo®, will be
used additional to usual care.
CONTROL: Usual care will be provided according to the treating physician and
may comprise pain control with analgesics, early rehabilitation and preventive
osteoporosis medication.

Dynamic bracing is expected to be safe. There are no additional visits at the
outpatient clinic or investigations in comparison to standard care. We expect a
benefit for the patients who are in the intervention group since we expect the
brace to provide better pain relief in comparison to standard care alone.
For patients included in the Maastricht University Medical Center gait quality
and postural balance will be assessed using the computer-assisted
rehabilitation environment (CAREN, Motek-force Link). The risk of the gait
analysis is negligible. A safety harness provides protection against falling.
It will avoid subject falling on or off the treadmill while performing
training. The safety harness is secured with a lifeline to the ceiling. The
gait analysis compromises the only burden; all other interventions are equal to
normal clinical practice. The gait analysis will take approximately 60 to 90
minutes.