Now there’s a better solution than fusion for spondylolisthesis and spinal stenosis. In fact, the FDA has recognized and labelled the TOPS™ System as clinically superior to fusion.
You may qualify for the TOPS™ Lumbar Motion Device:
- Have
spinal stenosis
/ spondylolisthesis - No disc
herniation - Have Medicare or other medical insurance
Your Benefits:
- Addresses leg and back pain
- Preserves motion. No fusion
- Clinical superiority
- FDA and Medicare Breakthrough Device
What do I Gain?
If you have been indicated for a lumbar fusion, TOPS may be a viable alternative for you. You may be able to avoid having your vertebrae rigidly fixed together in a fusion surgery. TOPS is an artificial joint for your lower back—like a hip or knee replacement. In a head-to-head FDA clinical trial, the TOPS System outperformed fusion. In fact, the FDA has recognized and labelled the TOPS™ System as clinically superior to fusion.
What are Patients Saying?
David danced at his kid's wedding
Bonnie explains why TOPS surgery was the right decision for her
Keith Thomas's Patient Review about Back Pain Relief
Virginia Overcomes Debilitating Back Pain with TOPS™
Sarah's Remarkable Journey from Chronic Pain to Active Living
What is the TOPS System?
The TOPS™ System is a dynamic implant which stabilizes the spine without rigid spinal fixation. Your disc remains untouched, unlike a fusion. The TOPS is implanted at the diseased level (typically L3-L4 or L4-L5) following lumbar decompression to alleviate pain stemming from spinal stenosis and degenerative spondylolisthesis. Spinal stenosis is a narrowing of the spinal canal, which causes a pinching of the spinal cord and nerve roots that extend from the spine to the legs. Degenerative spondylolisthesis refers to an abnormal slip of one spinal vertebra in relation its neighbor that causes pain in the lower back and legs.
Providing More Flexibility in the Treatment of Spinal Stenosis and Spondylolisthesis
Pain relief is achieved when your surgeon removes the bone elements that press on your nerves. Upon completing lumbar decompression, the surgeon implants the TOPS System to replace the extracted skeletal structures and stabilize the spine. With the TOPS™ System, clinicians can remove all elements pressing on your nerve roots without concern for fusion to occur—because there is no fusion. Instead of permanently locking two adjacent vertebrae, your surgeon allows the two vertebrae to continue moving normally with the support of the TOPS™ implant. The TOPS™ System allows full motion at the operative level, while prohibiting excessive twists and turns. The result is motion preservation, optimum decompression, spine stability, and pain relief.
Patients typically experience immediate pain relief post-surgery. Most patients are on their feet and walking the next day, and claim they haven’t felt so pain-free in years. As there is no fusion taking place in the lower back with the TOPS™ System, there are very few restrictions on activity. Full recuperation varies from patient to patient. You can expect an immediate benefit and progressive improvement as you undergo a strengthening and rehabilitation program. In addition, you have the long-term benefit of reducing the stress and strain on the adjacent levels.
Adjacent level disease or adjacent segment degeneration is a condition that can occur after a spinal fusion. It impacts the motion segments (i.e., the disc and facet joints) above and below the surgery site. After a fusion surgery, you lose movement at the spine segment where the procedure was done. But motion has to come from somewhere to accommodate your daily activity—twisting, walking, reaching, and lifting. Usually, it comes from the joints next to the surgery site. These joints have to do double duty in order to make up for the (now) immovable portion of your spine. As such they are subject to extra stress, and this may lead to degenerative changes. Adjacent level disease is the result of extra wear and tear on the intervertebral joints above and below your surgery site.
Attaining Superior Clinical Outcomes for Surgical Decompression Patients
The TOPS™ System mimics the natural motion of the spine in all directions – flexion, extension, lateral bending, and axial rotation. At the same time it also blocks sheer forces, which are naturally exerted on the lower spine and can be detrimental, especially for patients who already have a slipped disc or spondylolisthesis. This cannot be achieved with a decompression-only procedure or with an intraspinous or intralaminar device. Clinically proven to provide immediate and sustained pain relief and improvement in quality of life, Premia Spine’s TOPS™ System has also been demonstrated to provide excellent outcomes for appropriate patients.
The TOPS System provides three major benefits for the treatment of spinal stenosis, spondylolisthesis and other diseases of the facet joint:
- Spine Stabilization
- Controlled Motion
- Sustained Pain Relief
First, the procedure stabilizes the lumbar spine and reestablishes a controlled range of movement. Second, patients regain their ability to bend, flex, walk, and enjoy the normal activities of life. Third, and most importantly, patients experience immediate and sustained pain relief. Clinical studies conducted since 2005 show the TOPS System alleviates persistent leg and low back pain for patients with moderate to severe spinal stenosis with or without spondylolisthesis (a slipped disc) and facet arthrosis (bone spurs).