Fixano
This implant is in a U shape with a bracket above and below it. The u shaped curve is flexible in order to provide flexibility. The brackets are attached to the spinous processes and the u shaped curve is inserted in posterior articular processes. The device provides flexible support of the posterior column. It permits flexion and extension of the lumbar spine, although it restricts mobility in extension and rotation. The Interspinous U functions by reducing pressure on the posterior joints, restricting mobility, reducing hyperlordosis, and opening up the foramina. The device is now thought to have more reaching indications then originally designed for, including:
Materials:
Titane TA6V
Sizes:
10-14mm
Surgical Procedure:
The site for the implant is prepared by disecting the supraspinous ligament, resecting the spinous processes to give them the right shape to receive the implant, removing the interspinous ligament, and decompressing the canal. Then a sizing template is inserted. The implant is loaded into the insertion instrument, positioned, and then secured by crimping the wings
.
Indications:
- Adjacent level to rigid fixation
- Adjacent to spinal decompression
- Recurrent disc herniation
- Central canal stenosis
- Lateral canal stenosis
- Early-stage DDD
Effect:
The implant is designed to provide decompression and support for the spinal processes.
Studies:
In a clinical study done by Dr. Samani, one hundred and seventeen implants wher eimplanted in to one hundred and six patients. It was use seventy five percent of the time by itself, and twenty five percent of the time accompanied by fusion. In the eighty patients implanted with the stand alone U, seventy four percent reported excellent results. However, patients with severe lumbar spinal stenosis had to have revision with wider laminectomies.
Success Rates:
There is no controlled study of this device's success in treating lumbar spinal stenosis. The one study that was done seemed to have complications with the device in treating lumbar spinal stenosis.
Availability:
While availabile everywhere except the US and Japan.