SAMBASCREW™ System is intended for fixation of sacroiliac joint disruptions. This fixation device is to only be used in skeletally mature patients.The product is distributed by Orthofix.
SI Joint Fusion with the SAMBA™ Screw System The sacroiliac joint is a documented source of lower back pain. Review of the literature shows that in up to 30% of patients with lumbago, the sacroiliac joint is the most likely source of pain. The stress across the sacroiliac joint following lumbar fusion, especially at the L5-S1 level, appears to be the most common etiology. Other causes include trauma, postpartum, heavy weight lifting, and arthritis. In a small subset of patients, the sacroiliac joint discomfort is of unknown etiology. It is more common in females. This condition is diagnosed by the patient’s history, physical findings, radiological investigations and sacroiliac joint injections which is the gold standard to confirm this condition. Sacroiliac joint fixation or arthrodesis is indicated in patients with severe, chronic sacroiliac joint pain who have failed extensive conservative measures, or in acute cases of trauma.
Features:
- The SAMBASCREW™ is a hollow–body titanium threaded fusion device,
designed with multiple orifices on its shaft to promote arthrodesis across the
Sacroiliac Joint (SI joint). - The SAMBASCREW™ incorporates radial slots along the screw’s body intended
to optimize surrounding bone access to the bone substitute, allowing greater
bone growth through the SAMBASCREW™. - Specifically designed instrument to enable delivery through the SAMBASCREW™ of additional osteogenic and osteoconductive material into the Sacroiliac Joint.
- Tapered screw tip to aid in guidance through pilot hole.
- Multiple long flutes to reduce torque and increase fixation.
- Low profile screw head prevents soft tissue irritation.
- Implant threaded in place in a controlled manner.
- Precision machined devices in a range of lengths to accommodate patient
anatomy. Available in 6 lengths in 5mm increments, 25mm – 50mm. - Minimally Invasive Surgical (MIS) approach.
- Technique designed to prevent nerve injury.
- Safe, fast and promotes fusion across the SI Joint with immediate stabilization.
- Great pullout strength with low chance of migration of implant.
- Implant is flush with ilium for greater patient comfort.
- Fewer steps compared to other techniques.
- Specialized instruments designed to implant the SAMBASCREW™.
Benefits:
- Minimally Invasive Surgical (MIS) approach.
- Technique designed to prevent nerve injury.
- Safe, fast and promotes fusion across the SI Joint with immediate stabilization.
- Great pullout strength with low chance of migration of implant.
- Implant is flush with Ilium for greater patient comfort.
- Fewer steps compared to other techniques.
- Specialized instruments designed to implant the SAMBATM Screw.
- Comprehensive system requires minimal instrumentation.
About Medical Designs, LLC
With an idea for an existing device modification, Sioux Falls, South Dakota-based physician and neurosurgeon, Wilson T. Asfora proposed his design to a major medical device corporation. After receiving no recognition other than a thank you letter from the corporation, Dr. Asfora founded his own medical device company, Medical Designs, LLC in 1999. http://medicaldesignsllc.com
About Sacroiliac joint fusion technique
Sacroiliac joint dysfunction is responsible for 25% of lower back pain cases across the world. This is generally used to treat back or leg pain caused by SI joint dysfunction. Within the past few years, there has been resurgence in the recognition of the SI joint as a potential source of low back pain as treatment options for SI joint dysfunction have advanced.Numerous techniques exist for the surgical treatment of sacroiliac joint dysfunction. The main goal is to stabilize the joint by using implants and sometimes instrumentation.