Premia Spine – Advantages of the TOPS™ System Over Other Similar Spine Implants
Patients now have a new treatment option for spinal stenosis and spondylolisthesis. Though decompression surgery is still essential, there is another way to go about protecting the spine and still allowing movement with the TOPS surgery. Spine issues often indicate that people can’t bend or twist. They may have pain in the legs and back and require medications and physical therapy.
When those aren’t enough, fusion surgery used to be the only option available. With this, two vertebrae are “glued” together to prevent too much movement. This is a permanent thing and can’t be reversed. Over time, those two vertebrae become one, which indicates that the surgery was a success.
The issue here is that the patient can never move the same way again. They may never bend over at the waist, twist slightly, or flex the spine. Though doctors know the risk and point it out to patients, most physicians feel that this was the best choice and offered more benefits than drawbacks.
However, one company didn’t take this lying down and felt that there was another option. With many years of research and trials, the TOPS alternative was born.
What Is the TOPS Implant?
The TOPS device is an alternative solution to spine fusion surgery for people with severe or moderate degenerative spondylolisthesis or lumbar spinal stenosis. It focuses on addressing two functions of a person’s spine: preserving motion and maintaining stability.
Typically, the surgeon must remove bony elements pressing on the nerves with decompression. However, instead of fusing two vertebrae together, he or she implants TOPS. Premia Spine has worked for over 15 years to make this happen, and it recently went through clinical trials and is available in some countries.
With the TOPS implant, surgeons can stabilize the spine as it should be while re-establishing the person’s range of motion within. Patients who experience sciatica, a burning sensation, low back pain, tingling, numbness, and radiating leg pain can now regain the ability to walk, flex, bend, and do regular life activities that had been debilitating in the past.
How Does the TOPS Implant Work?
Fusion of the vertebrae requires the bones to be glued together, but TOPS moves in tandem with the spine. It is designed to let the person shift around as normal but provides protection, too.
In a sense, your body can move like it is supposed to, but only to the degree allowed by TOPS. Premia Spine focused its attention solely on offering an alternative to fusion and other spine implants.
For example, types of spinal implants can include:
- Cages – These devices use a hollow center with perforated walls and can be used for patients that have a collapsed disc. Generally, the cage goes around particular discs to encourage more bone growth.
- Hooks – Typically, hooks are used with rods and other devices to keep things anchored.
- Plates – Doctors can conform the plates to meet the spine’s shape, and they’re held in place with screws.
- Pedicle Screws – You can use pedicle screws to anchor the plates and cages, or they can secure a bone fracture.
- Rods – Generally, rods are flexible to limit the movement of some vertebrae to correct issues and can be smooth, threaded, or round.
- Spinal Cord Stimulator – This implant sends electric shocks to the person’s spine to reduce back pain.
Though the TOPS alternative does use rods and pedicle screws to keep it in place, this device is unique and different from anything on the market. There are two separate pieces (one on the top and bottom) with a flexible middle to allow movement without damage to the spine.
What Are the Advantages of Using the TOPS Alternative?
After reading many TOPS spinal surgery reviews, you know that this implant works and does better than cages, stimulators, and fusion. However, what are the advantages of the TOPS alternative?
Primarily, the TOPS implant allows the spine to move in all directions – axial rotation, lateral bending, extension, and flexion. However, while it is doing that, the system blocks sheer forces that are naturally and continually exerted onto the low spine. These can be highly detrimental and damaging, especially when the patient is recovering from surgery.
Clinical studies prove that this system offers immediate pain relief, which is sustained throughout the weeks, months, and years after the TOPS surgery. Spine improvement continues over time, and the patient sees an enhancement of their quality of life.
Studies have also shown that the TOPS System demonstrates much better outcomes than traditional spinal fusion surgery, though only in appropriate patients. This typically indicates people who suffer from lumbar spondylolisthesis or lumbar spinal stenosis.
There are three significant benefits of the TOPS alternative. For one, the procedure can stabilize the posterior spine. This means that the person feels no more pain, and the body doesn’t move uncontrollably. With that, you also see a controlled range of motion.
What that means is the spine is only designed to move specific ways; therefore, movements are contained and constrained in the way that the spine should move safely. This indicates that the patient isn’t going to overexert themselves or do more damage while healing from TOPS surgery. Spine surgeons like the idea of allowing the person to move around the day after the procedure. It ensures that they’re exercising the area and working to improve almost immediately.
The second advantage of the TOPS implant is that patients regain the ability to enjoy their regular activities, such as bending, flexing, and walking. With fusion surgery, the person’s motions are highly limited. It takes more time to recover from the procedure, but the patient may never move fully as they did before the pain.
Most importantly, patients have immediate pain relief that continues as they improve. For people with severe or moderate spinal stenosis with or without facet arthrosis (a bone spur) or spondylolisthesis (slipped discs), they can alleviate the persistent low back and leg aches.
What Are the Risks Associated with TOPS™ System Surgery?
As with any surgery, surgical treatment of lumbar spine disorders is not without risk. A variety of complications related to the surgery or the use of the TOPS™ System may occur. Potential adverse effects (i.e., complications, risks) associated with the use of the TOPS™ System identified from the TOPS™ System clinical trial results, use of the TOPS™ System outside of the United States, approved device labeling for other lumbar spinal devices, and published scientific literature appear in the package insert of the device. The Adverse Effects are sub-divided into three categories: (1) those commonly associated with any surgical procedure; (2) those associated with lumbar spinal surgery procedures using a posterior approach; and (3) those associated with posterior spinal implants, including those pertaining to the TOPS™ System. These risks may occur singly or in combination, and may be severe and/or negatively impact patient outcomes.
The list below is not a full list of risks. There may be other risks with treatment using the TOPS™ System. There is the possibility that this surgery may not be effective in relieving your symptoms. It is possible your symptoms could worsen. If this happens, you may require additional surgery. You should discuss these risks and any concerns with your doctor before deciding to have TOP™ System surgery.
A complete list of Risks is provided in the package insert for the device, which your doctor has received. Please ask your doctor for more information about any additional Risks that could be related to your planned surgery.
Risks Associated with Any Surgery:
General surgical risks are, but not limited to:
- Anesthesia complications including allergic reaction to the drugs used to put you to sleep for surgery.
- Wound healing complications at the surgical cut. Infection in the blood or at the surgical cut.
- Soft tissue damage or fluid collections which may require draining or other surgical or pharmacological intervention.
- Lung problems including pneumonia, collapsed lung, and blood clots.
- Post-surgical pain, bruising, tenderness, sensitivity or discomfort at the surgical incision or the skin over the incision which may result in skin healing complications, irritation, or pain.
- Neurological complications including nerve damage, paralysis, seizures or convulsions, changes to mental status.
- Narcotic addiction.
- Continued bleeding after surgery and possible collection of blood or scarring on the covering of the spinal cord. This may require another surgery or transmission of more blood (transfusion).
- Problems associated with the heart or blood movement. In rare instances, heart attack, stroke, or death can occur.
Risks Associated with Lumbar Spine Surgery:
- Injury or damage at the surgery site area, including to the spinal cord, nerves, cover (dura), blood vessels, and skin.
- Spinal cord damage with potential spinal fluid leakage, leading to temporary or permanent headaches, paralysis or numbness, tingling, or weakness.
- Surgery at the wrong level.
- Adverse reaction and allergy to the device materials or device wear debris from Titanium, Polycarbonate Urethane (PCU), and Polyether Ether Ketone (PEEK)], which may lead to an adverse reaction of the local tissues or chronic inflammation that may lead to implant loosening or failure of the device, adverse tissue reaction, progressive breakdown of bony tissue, tumor formation, autoimmune disease, scarring, or other symptoms.
- Degenerative changes at adjacent segment to the level of your spine surgery.
- Loss of bowel or bladder function, or incontinence (loss of bowel or bladder control).
- Fracture of the vertebrae, spinous process, or other damage to bony structures during or after surgery.
- Postoperative muscle and tissue pain.
- Pain and discomfort associated with the presence of implants.
- Pain and discomfort associated with the surgical procedure (e.g., cutting of muscles, ligaments, and tissue) and healing.
- The spine may undergo adverse changes or deterioration including loss of proper spinal curvature, correction, height, and/or reduction, or malalignment, and another surgery may be required.
Risks Associated with posterior spinal implants, including the TOPS™ System:
Risks specific to posterior spinal implants, including the TOPS™ System, are, but not limited to:
- Removal, revision, reoperation or additional fixation after procedure.
- Additional surgery due to loosening, breaking, or wearing.
- Bone formation or fusion.
- Difficulty placing the pedicle screws or TOPS device properly in the spine.
- Development of new pain or failure of the device to improve existing symptoms or function.
- Issues with the device surgical instruments.
- Device/joint noise.
- Degeneration, fracture, or other changes in alignment of the spine or loss of proper spine curvature, height, motion or stability.
Why Research Your Options
It is surprising how many people take fusion surgery as the only option. However, you have other choices available to you, including TOPS. Premia Spine has worked hard to develop this system, test it, do clinical trials, and is now offering it to various countries.
Though surgeons have to research the system and figure out how to use it correctly, things are progressing well.
Patients who must undergo decompression surgery are sure to hear about the TOPS alternative and want to know more. It’s ideal to read TOPS spinal surgery reviews to find out what happened in similar cases to yours. That way, you have more confidence and understand that this is an excellent choice for your spinal issues.
During your research, talk to your doctor about every treatment option available. Many of them aren’t offering the TOPS implant, but it isn’t because they don’t want to. Most of the time, these surgeons wish to try a new procedure and can’t find anyone who wants it. Some patients stick with fusion therapy but only because they don’t know what’s on the market.
When you take the initiative and ask your doctor about the TOPS alternative, you are actively participating in your well-being and healthcare. It shows that you’ve researched your options thoroughly and feel that this is the right choice for you.
Now, you have to go through the pros and cons with your surgeon to ensure that you are a suitable candidate for TOPS. Premia Spine focuses on innovation, and its new alternative is often better than other spine implants or fusion surgery.
Do you currently suffer from spondylolisthesis or spinal stenosis? If so, your doctor may have recommended surgery to alleviate your pain. Ask about the TOPS alternative to see if it’s right for you.
With it, you can experience more controlled movement, have less pain, and regain your ability to do your regular activities. Improve your quality of life with the TOPS implant!