Three days after the operation, I would walk up and down the stairs in the hospital, artificial stairs without assistance. I got up and walked the length of the room. I didn't believe it myself, but I had that kind of mobility. The pain was gone.

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Frequently Asked Questions about Leg and Back Pain and the TOPS™ System Solution

Q: What area of the spine does spinal stenosis affect?

A: Spinal stenosis is a progressive degeneration of the entire posterior complex. It typically impacts the lower back, often referred to as the lumbar spine, with radiating pain to the legs and buttocks.

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Q: How is lumbar spinal stenosis treated?

A: The treatment of spinal stenosis varies according to the extent of the disease. Typically, a doctor will administer 6 months of “conservative treatment”. This can be a combination of rest, over-the-counter and/or prescription medication, acupuncture, and exercise that induces stretching. If the patient fails to achieve pain relief, the doctor can resort to various surgical interventions ranging from a spinal decompression to a decompression combined with the implantation of a mechanical structure to restabilize the spine after the spinal decompression surgery.

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Q: What is a standard lumbar decompression?

A: As each patient has different problems and severities, there is not a ”standard” lumbar spinal decompression surgery. But the goal is the same in all lumbar decompression surgery — to eliminate pain without compromising the patient’s stability. Back and leg pain can be caused by nerve roots that are pressed upon by either annulus or nucleus of the spinal disc, or the bony posterior elements such as the lamina and facet joints, or ligaments/soft tissues. Decompression is the surgical removal of those elements that are pressing on nerves. The decompression alleviates pain by freeing up the nerve roots.

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Q: What types of lumbar decompression are performed?

A: The surgical spine decompressionprocedure is dictated by the location and the extent of nerve impingement. Isolated impingement created by soft tissue or disc materials that are easily accessed may lend itself to an endoscopic approach using tools that function similarly to endoscopic tools used in gall bladder removal. Other forms of impingement, especially those related to the bony facet joint or lamina that are pressing on nerves, typically are removed through a small incision under direct visualization by the surgeon. Many surgeons will categorize this approach as a minimally invasive procedure. If the impingement is extensive, and requires significant disc and/or bone resection, the surgeon may conclude that mechanical instrumentation must be implanted into the patient’s back to stabilize the spine. There are a variety of implants available. Generally, the clinician must decide if he/she wants to eliminate motion in an effort to stabilize the spinal segment or to preserve motion potentially at the expense of stability. This decision is driven by (a) the philosophy of the surgeon with regard to the benefits of motion versus the concern for adverse effects of fusion, (b) the age and level of activity of the patient, (c) the specific disease of the patient, and (d) its match to a satisfactory fusion or motion solution.

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Q: How does a lumbar decompression for spinal stenosis treatment affect the posterior complex?

A: The purpose of the lumbar decompression is to try and ensure that no future osteophytes, restenosis, or nerve root impingement occurs at the operative level. Decompression frees up the nerve roots and eliminates pain, but the decompression can destabilize the posterior complex. Ultimately, a decompression removes spinal structures that, when healthy, play an important role in spinal stability and function.

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Q: Will lumbar decompression ensure that I will not encounter future back pain?

A: No. In fact, various studies indicate that disruption of one or more posterior elements affect the overall integrity of the posterior column and can lead to instability and pain. In order to re-establish stability after a decompression, devices are implanted into the spine to stabilize the area. The most common implant is a spine fusion—a combination of screws, rods and cages that eliminate motion and stabilize the spine.

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Q: Are there any downsides to spinal fusion?

A: Spinal fusion can be a very successful procedure. However, patients should be aware that the re-operative rate for spinal fusion among patients 65 years old and above is 28% within two years of surgery according to Medicare. The need for a re-operation can be the result of a lack of successful fusion, the progression of the disease to the neighboring spine segment due to the transfer of loads that require an additional fusion, or the failure of the implants.

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Q: What does the TOPS System offer that lumbar decompression and fusion do not?

A: The TOPS System stabilizes the spine while maintaining the motion segment rather than fusing it or leaving it unprotected. This operation is completed through a procedure known as Posterior Arthroplasty. Posterior Arthroplasty is defined as the complete reconstruction of all posterior elements removed during the decompression utilizing a motion spinal implant. It represents a revolutionary approach to stabilizing a decompressed spine level by recreating the posterior complex rather than eliminating it via fusion.

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Q: How does Posterior Arthroplasty differ from spinal spacers and other minimally invasive widgets?

A: Arthroplasty is the complete and total replacement of the entire posterior element complex with a biomechanical structure. It is akin to a proper knee replacement or hip replacement. Less robust implants cannot provide the full functionality of the posterior complex nor can they allow the surgeon to perform as thorough a decompression of the diseased spine.

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Q: What is the design and function of the TOPS System?

A: The TOPS™ System is a pedicle screw based device implanted posteriorly to reconstruct the motion segment. It is a unitary device composed of two titanium end plates with an interlocking polycarbonate urethane articulating core. The device mimics the natural kinematics of the spine for controlled motion and sagittal stabilization. The TOPS System is designed to resist excessive motion in flexion, extension, lateral bending, axial rotation and sagittal translation. No other device thoroughly covers all directions and ranges of motion.

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