Dynamic bracing for OVCFs

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.

In patients suffering from an OVCF dynamic bracing will improve quality of life with a positive effect on pain and sagittal spinal alignment. Dynamic bracing improves gait quality and balance, as well as physical activity, and decreases the recurrence rate of OVCFs. As such dynamic bracing is a cost-effective treatment for patients suffering from an OVCF.

All primary and secondary outcome parameters will be obtained at baseline, after 6 weeks, 3, 6 and 9 months, and at 1 year after baseline.

This is a multicenter, two-armed, parallel-group randomized controlled trial with a 1:1 allocation ratio consisting of an effect, economic and process evaluation. Postmenopausal women with a recent symptomatic thoracolumbar OVCF will be randomized into either the standard care or dynamic brace group. Standard care will consist of analgesics, anti-osteoporosis medication and optionally physical therapy at the discretion of the treating physician and according to current and local clinical guidelines. Patients allocated to the intervention group will receive a dynamic thoracolumbar brace, the Spinova Osteo® (Bauerfeind Benelux B.V.) in addition to standard care, which they will be instructed to wear for at least eight hours a day. Compliance to the brace treatment will be controlled via temperature sensors which will be implemented in the braces. Moreover, we will use patient diaries for optimal comparison between patients and to check adherence to the treatment. The Spinova Osteo® brace will be fitted by the local orthopaedic technician on the day of or within a few days after inclusion.