VCFix is a revolutionary vertebral body augmentation system to improve pain control and stabilize the spine in patients suffering from Vertebral Compression Fractures (VCFs).
- Customized fracture reduction,
- Titanium porous structure to stimulate osseointegration and natural healing process,
- Stabilization of the vertebra without using PMMA bone cement and therefore avoiding all the related. complications.
VCFix is a more natural approach to VCF treatment and is ultimately preferred for younger patients. It is optimized for strong mechanical properties, maximum fracture reduction, and maximum Osseo-inductivity. Its wedge shape opening provides better anatomical restoration and angle correction. VCFix has pedicle anchorage for better stability and optional posterior fixation for more unstable fractures and it is provided with a single-use sterile kit for perfect traceability and reduced risks of infection.
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.
Patient with VCF often experience:
● Severe back pain that may limit mobility,
● An increased mortality in an already vulnerable elderly population.
● Loss of vertebral height and increase of kyphosis
● Respiratory and abdominal restrictions, early satiety and weight loss.
● Increased risk of secondary vertebral fractures.
● Loss of self-esteem, isolation, Distorted body image, Loss of independence, Depression, sleep disorder
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%).
VCFix 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.