The current focus of Amber Implants is on the development of Vertebral Body Augmentation (VBA) implants to improve pain control and stabilize the spine in patients suffering from Vertebral Body Compression Fractures.
Our design is developed to overcome the complications of the current VBA techniques, such as the adjacent fractures, embolism, cement leakage and neurological deficits by the elimination of bone cement.
The uniqueness of our design resides in three main points:
- Customized in-situ expansion and angle correction,
- Titanium porous structure to fasten osseointegration and patient mobilization,
- Secured inside the vertebra without using PMMA bone cement and therefore avoiding all the related complications.
Vertebral Compression Fractures (VCFs) are cracks in vertebral body, which often occurs due to osteoporosis and low bone density on old patients, but also can be caused by trauma, tumor or other bone diseases. Many patients with compression fractures actually do not develop significant pain, at least not enough to warrant a medical evaluation. In many other instances, however, these fractures can be very painful. Patients with severe VCFs often experience severe back pain that may limit mobility and leading disability, and subsequently increase mortality in an already vulnerable elderly population (Laratta et al., 2017). Back pain due to VCFs may also result in decreased exercise tolerance and reduced abdominal space, causing respiratory and abdominal restrictions, and may give rise to early satiety and vertebra weight loss. Sleep disorders may also occur.
Apart from pain, vertebral compression fractures result in loss of overall body height and angulation deformity, whereby the spinal column at the point of fracture becomes abnormally bent, usually forward. This often results in significant posture changes, which can lead to more pain due to muscle spasm and other adjustments. Patients can lose self-esteem (they become fearful of further fracture, have a distorted body image and poor health perception, for instance), and develop mental disorders like depression, and as a result, self-care may become difficult. Moreover, patients with one vertebral fracture are at increased risk of peripheral and further vertebral fracture.
In the past years, due to aging of the population, a growing incidence of spinal disorders (SD) and associated pain has been reported resulting in a steady increase in the number of surgical treatments worldwide. In North America, the lifetime risk of clinically evident vertebral fracture is 15.6% for 50-year-old women, and this number increases with the age due to increase of osteoporosis in older people. It is estimated that VCF affects around 1.4 million patients globally every year. In the USA, approximately 700,000 new osteoporotic fractures are seen every year, of which one-third become chronically painful and therefore diagnosed. However, it is difficult to give a very precise estimation because not all fractures come to the attention of clinicians and they are not always recognized on x-rays.
The aims of treatment of patients with VCF are to reduce symptoms (pain and spine instability and kyphosis) and mobilize the patient as quickly as possible. Patients with more severe broken vertebrae, spinal deformities or spinal disorders will eventually undergo spinal surgery. Hereof, minimally Invasive Surgery (MIS) procedures are used to treat severe VBCFs caused by osteoporosis, traumatic injury and pathological fractures (such as metastasis, osteomyelitis or Paget’s disease) to restore mobility, reduce pain, minimize the incidence of new fractures, stabilize the bone and restore the natural spine alignment (kyphosis) by restoring the lost vertebral body height.
Traditional procedures such as Vertebroplasty (first-generation) and Kypoplasty (second-generation) are not able to completely restore the vertebra height, and involve important risk factors such as bone cement leaks and the collapse of adjacent healthy levels. Due to this fact, a third generation of procedures using implants are being used to avoid the risks that could endanger the health of the patient.
1st and 2nd generation treatments:
KAVIAR study: Patients with osteoporotic vertebral body compression fractures will be randomly assigned to treatment with balloon kyphoplasty (191 patients) or vertebroplasty (190 patients). This study has reported more than 65% serious adverse events for both surgeries including fall (15%), remaining back pain (22%), lumbar and thoracic vertebral fracture (16%). Also around 30% of non-serious adverse events has been reported.
3rd generation treatments:
Amber Implants has performed a thorough literature study on third generation devices, including total 1219 fractures in clinical studies and 326 fractures in preclinical studies. The outcome of this research shows that the most often occurring complications in the third generation treatments (implants) are adjacent fractures (5-11%), and cement leakage (15-25%). More information can be found in the our scientific report.