Lumbar Pedicle Screw Placement: How to Enhance Spine Stabilization

Lumbar Pedicle Screw Placement: How to Enhance Spine Stabilization

Traditional methods used for lumbar pedicle screw placement often face challenges such as high costs, intensive training, and lengthy procedures. However, Ruthless Spine's innovative RJB system offers an alternate solution that simplifies the process while enhancing efficiency.

A 3D rendered image of Lumbar Pedicle Screw Placement during Spine Stabilization.

Understanding Lumbar Pedicle Screw Placement

What is Lumbar Pedicle Screw Placement?

Lumbar pedicle screw placement is a surgical technique used to stabilize the spine by inserting screws into the pedicles of the vertebrae. This procedure is essential in treating various spinal conditions, including fractures, degenerative disc disease, and scoliosis.

Challenges in Traditional Methods of Lumbar Pedicle Screw Placement

Traditional methods, such as freehand techniques and fluoroscopy-guided systems, often come with significant drawbacks. These include the need for extensive preoperative planning, high radiation exposure, and the potential for screw misplacement, leading to complications and revision surgeries​​​​.

Ruthless Spine's RJB System: A Revolutionary Solution

Overview of the RJB System

Ruthless Spine's RJB system is an intraoperative surgical angle measurement tool designed for lumbosacral pedicle screw procedures. This FDA-cleared device offers a simplified yet highly effective approach to spinal surgery, leveraging modern technology​​​​.

Ruthless Spine's RJB system setup with a tablet displaying real-time trajectory visualization

Key Features and Benefits

Simplified Setup and Use

The RJB system is compatible with off-the-shelf Android or iOS tablets, eliminating the need for bulky and expensive machinery. Surgeons can set up the system in under five seconds, significantly reducing operating room time​​.

Continuous Connectivity

The Bluetooth-connected module ensures that the device maintains a reliable connection throughout the procedure, even if the line of sight is blocked​​.

Real-Time Visualization

The RJB provides real-time visualization of the axial and sagittal trajectory of the instrument shaft on the tablet screen. This feature allows for precise adjustments during surgery​​.

RJB intraoperative surgical angle measurement tool

FDA Clearance and Compliance

The RJB system has received FDA clearance under De Novo classification, affirming its safety and effectiveness for use in lumbar pedicle screw procedures. This regulatory milestone underscores Ruthless Spine's commitment to providing innovative and compliant solutions for spine surgery​​​​.

Ruthless Spine's Mission

Ruthless Spine's mission is to revolutionize spine surgery by simplifying and enhancing surgical navigation. They aim to bring "zen" back to spine surgery by addressing the challenges faced by spinal surgeons, such as the need for significant investments in capital, time, and manpower to achieve accurate outcomes. Ruthless Spine focuses on providing innovative, accurate, and efficient solutions that are easy to use and do not require bulky, complex machinery.

References

  • Ruthless Spine RJB Information. (2023). Retrieved from Ruthless Spine
  • FDA Medical Devices Databases. (2023). Device Classification Under Section 513(f)(2)(De Novo). Retrieved from FDA
  • Ruthless Spine Company Information. (2023). Retrieved from Ruthless Spine
  • Lee, H. M., Suk, K. S., Kim, J. T., & Moon, S. H. (2014). The long-term effect of instrumentation removal after posterolateral lumbar fusion. Asian Spine Journal, 8(2), 212-220. https://doi.org/10.4184/asj.2014.8.2.212

References:

  1. Waschke A, Walter J, Duenisch P, Reichart R, Kalff R, Ewald C. CT-navigation versus fluoroscopy-guided placement of pedicle screws at the thoracolumbar spine: single center experience of 4,500 screws. Eur Spine J. 2013 Mar;22(3):654-60. doi: 10.1007/s00586-012-2509-3. Epub2012 Sep 23. PMID: 23001415; PMCID: PMC3585623.
  2. Nevzati E, Marbacher S, Soleman J, et al. Accuracy of pedicle screw placement in the thoracic and lumbosacral spine using a conventional intraoperative fluoroscopy-guided technique: a national neurosurgical education and training center analysis of 1236 consecutive screws. World Neurosurg. 2014;82(5):866-71.e712. doi:10.1016/j.wneu.2014.06.023
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