Bonnie is an architect and a lifetime New Yorker. She takes pride in tackling the city’s demanding lifestyle, from climbing subway stairs to walking to the theater and even lugging around granite samples. But, when she began to experience rapidly progressing numbness in her legs, she could no longer keep up with her day-to-day activities.
Upon undergoing an MRI, Bonnie discovered that she had spondylolisthesis of the L4-L5 spinal segment. Though this is a common condition, it was highly debilitating and greatly diminished Bonnie’s quality of life.
Multiple surgeons told Bonnie to undergo spinal fusion. To avoid this procedure, she tried all forms of conservative treatment, to no avail. The numbness escalated into radiating pain, and Bonnie lost the ability to participate in the New York lifestyle that she loved.
Once Bonnie discovered the Premia Spine TOPS System and its ability to preserve the natural motion of the spine, she was thrilled. After surgery, her radiating pain was gone, and she was back to climbing stairs within just a few days.
Just 10 months after surgery, Bonnie has no limitations and is back to her old self. She’s overwhelmed by the impact that the TOPS System has had on her quality of life.
Scott was experiencing gradually worsening back pain throughout adulthood, without a particular cause. Time and hard work simply took their toll on Scott’s spine, ultimately altering his quality of life. Scott lost the ability to partake in activities that brought him joy, like playing with his grandchild and fishing.
A clinical trial involving the TOPS implant offered Scott the opportunity to find pain relief without the lost mobility associated with spinal fusion. The TOPS System is positioned on the posterior side of the spine and anchored to the bone with screws. The device creates a controlled range of motion in the spine.
Scott’s excited to see the results of his TOPS System clinical trial. He encourages other patients suffering from chronic back pain not to hesitate to seek out treatment, as solutions to improve their quality of life are available now.
Wade is a Utahn who has always been physically active. Between working out at the gym, hiking, fly fishing, and working around the yard. Unfortunately, Wade developed sciatica from spinal stenosis.
As Wade’s spinal stenosis progressed over time, he eventually had the sensation of being electrocuted and occasionally lost all sensation in his legs. He feared that he would never be able to return to work or any of the physical activities that he loved.
Wade conducted his own research to find a solution to his excruciating symptoms. This research led him to the TOPS System. Upon reading the TOPS System testimonials, studies, and trials, Wade was far more interested in TOPS than the conventional spinal stenosis treatment options.
After the TOPS procedure, Wade’s sciatica was completely resolved. Additionally, the TOPS spinal surgery recovery time was shorter than Wade predicted. He returned to work within just 30 days and now has returned to fly fishing, hiking, bicycling, and yard work.
Ester is a teacher who developed severe spinal pain in adulthood. She began to plan her life around her pain, as she couldn’t walk for more than three minutes without requiring a break. Ester’s mood began to suffer as she couldn’t tend to her garden, comfortably stand in front of the classroom, or travel with her family.
After seeking care from a specialist, Ester was diagnosed with severe spinal stenosis with a slipped L4-L5 spinal segment. The physician warned Ester that delaying surgery would be dangerous and could compromise her ability to walk. However, Ester was wary of spinal fusion, as it could cause significant, lingering pain and limited mobility.
Ester ultimately chose the TOPS System because it would prevent her spinal stenosis from reoccurring. Her pain was completely gone when she woke up after the procedure, and she was given no limitations upon her release from the hospital. Ester is now living a happy, vibrant, and pain-free life.
Before undergoing TOPS surgery, Vechesislav was experiencing tingling and weakness in the back and front of his legs with short periods of walking, as well as claudication. As time passed before the operation, the distance that Vechesislav could walk became shorter and shorter.
At only 43 years old, Vechesislav worried about his ability to work. With his condition gradually worsening, Vechesislav also feared that he may eventually require a wheelchair.
Given that Vechesislav must bend down to pick up objects at work, spinal fusion surgery and the associated loss in mobility seemed like a poor option. But, when he heard about the TOPS System reviews, Vechasislav knew it was the right choice. This mechanical implant would allow him to move faster and more efficiently at work.
On the fourth day after the TOPS procedure, Vechesislav was able to climb stairs and comfortably walk a short distance with no leg pain or claudication. His loved ones were shocked by how drastically the procedure improved his mobility and overall quality of life.
Kadriye, Sakina, and Suat’s Stories
Turkish patients Kadriye, Sakina, and Suat are all TOPS System success stories.
Kadriye experienced intolerable pain in her left leg while standing and walking before undergoing the TOPS procedure. After the surgery, she could move normally, without having to drag her left leg. Her mobility was so unrestricted that she forgot she had undergone surgery, and Kadriye can now walk any distance without pain or neurological symptoms.
Sakine couldn’t walk or stand from a sitting position without unbearable pain before the TOPS procedure. She was forced to hold onto a table to stand up, and even struggled to bend down to pray. Since the TOPS surgery, Sakine has been back on her feet with a new lease on life, even seven years after the procedure.
Suat experienced severe pain while walking, standing, and bending over before the TOPS procedure. After the surgery, Suat can comfortably complete all of these motions. His pain is entirely gone, and Suat notes that the procedure changed his life.
Yehuda struggled with the physical and mental effects of chronic back pain before the TOPS procedure. He struggled to focus on anything but his intense pain, which flared after walking even short distances. As an author, this greatly inhibited Yehuda’s performance and quality of life.
After trying epidural shots, acupuncture, and radiofrequency treatments to no avail, Yehuda realized that surgery was unavoidable. He quickly learned of the TOPS System and its ability to provide 360° spinal mobility.
Just three days after the TOPS procedure, Yehuda could walk up and down stairs in the hospital without assistance. His pain was entirely gone and, five years after the surgery, Yehuda is still pain-free.
Dr. Anekstein is the director of the spinal surgery unit at Assaf Harofeh Hospital. He specializes in degenerative diseases of the spine, which aren’t typical forms of back pain. These ailments, including spinal stenosis and spondylolisthesis, occur when the spine degenerates gradually with age.
Facet joint degeneration, in particular, often causes pain and neurological symptoms in patients’ 50s and 60s. Intervertebral disc degeneration typically begins earlier in life.
Some patients can manage degenerative spinal conditions with physical therapy, lifestyle changes, and other non-surgical treatments. However, surgery is required to stem the degeneration and cure conditions like spinal stenosis.
Laminectomy, a procedure to open up the spinal canal, is the standard surgical treatment for spinal stenosis. In cases of severe degeneration, this procedure can cause spinal instability and the symptoms may eventually return. Spinal fusion surgery can be implemented to prevent this instability, but can lead to degeneration in the neighboring segments.
The TOPS System is an implant that replaces the degenerated facet joint. Dr. Anekstein uses this device to facilitate movement between the vertebrae while relieving nerve compression. The average recovery time is one month before returning to full function.
Professor Yizhar Floman
Dr. Floman is an orthopedic spine surgeon. He typically sees patients with degenerative disc disease with or without deformities. Spinal stenosis is among the most prevalent conditions that Dr. Floman sees today, causing symptoms including chronic back pain and neurogenic claudication.
Non-surgical treatment often fails for spinal stenosis patients. In these cases, patients must consider surgery, which involves relieving the pressure on the neural elements. This has traditionally been combined with spinal fusion for stability.
Dr. Floman was attracted to the TOPS System’s ability to restore the normal motion of the spinal segment, which prevents further degeneration of the adjacent segments. This also helps prevent reoperation.
The most striking factor among Dr. Floman’s patients who have undergone the TOPS procedure is the rapid recovery process. Patients generally return to their normal activities within just two to three weeks and remain pain-free in the long term.
Professor Yizhar Floman on The TOPS System Long-Term Follow-Up
At the Eurospine conference, Dr. Floman discussed the long-term results of the TOPS System. He began by comparing spinal fusion to the TOPS System.
In one study, one out of four patients who underwent fusion required reoperation within the first two years of follow-up. Research also showed that at least 25% of patients failed to have a significant improvement in their disability after fusion.
Dr. Floman stated that “the TOPS System restores the biomechanics and preserves the kinematics of a destabilized motion segment”.
TOPS received FDA approval to conduct a pivotal U.S. trial. Of the 137 patients included in the trial, 71 were treated with TOPS and 66 were treated with fusion. The TOPS System demonstrated far better clinical results than fusion.
Dr. Floman and his team conducted a prospective study in Tel Aviv involving 10 patients with single-level stenosis of the L3 to L4 or L4 to L5 levels with degenerative spondylolisthesis. The patients were aged between 52 and 69.
In one patient, the prosthesis became stuck, and the case was converted to fusion. Nine patients were followed for six to seven years. These patients experienced very low back and leg pain levels, with preserved flexion, extension, and lateral bending.
Additionally, MRI and dynamic X-ray findings revealed that the patients experienced no device failure, pedicle screw loosening, or progressive degeneration at the index level of the disc. The patients reported high levels of satisfaction and function.
Dr. Robert Hes
Dr. Robert Hes works as a neurosurgeon in the spine department at a general hospital in Antwerp, Belgium. He works extensively on degenerative lumbar pathologies. In older patients, Dr. Hes often identifies spinal stenosis, degenerative scoliosis, and related issues.
Dr. Hes began to use the TOPS System in 2005, implementing the device for a few cases with a single level. However, his team soon gained access to the hybrid Versalink™ System for patients with severe stenosis, typically in the L3-L4 or L4-L5 spinal segments.
To evaluate the treatment’s long-term success, Dr. Hes gives his patients score forms before the procedure, keeping them until five to seven years after the surgery. He has found that with the TOPS and Versalink™ Systems, his patients’ satisfaction and clinical situations have remained very stable, with rapid symptom resolution after the procedure.
Dr. Robert Hes on The TOPS Hybrid Solution Long-Term Follow-Up
Dr. Robert Hes reported the results of the TOPS Hybrid Solution at 5-years follow-up.
Though Dr. Hes was initially concerned about the possibility of screw loosening, the TOPS System has a screw loosening rate of less than 0.2% worldwide. TOPS’ patented screw surface treatment is largely responsible for this low rate.
Dr. Hes and his team studied the differences between TOPS and the Dynesys device, finding that the TOPS System was superior in its ability to withstand the forces on the screws.
The TOPS System also provides a near-normal motion in flexion, extension, and lateral bending. Near-normal motion protects the adjacent spinal levels against degeneration.
Dr. Hes and his team conducted a study of the TOPS System with 15 patients aged between 46 and 72. These patients experienced sustained improvement in back pain, leg pain, and mobility, with no screw loosening or adjacent segment issues.
Dr. John Fowler
Dr. John Fowler discussed lumbar spinal stenosis and degenerative spondylolisthesis at the Eurospine conference. Lumbar spinal stenosis is characterized by the narrowing of the lumbar spinal canal. It leads to symptoms of nerve compression, including lower back and leg pain, as well as an inability to extend the spine.
Degenerative spondylolisthesis involves the anterior displacement of one vertebra. This condition most commonly occurs in the L4-L5 spinal level. It often leads to spinal stenosis.
Minimally-invasive surgery is Dr. Fowler’s preferred approach to lumbar spinal stenosis treatment. If he must destabilize the patient’s spine, he considers alternative forms of stabilization to spinal fusion. Unfortunately, Dr. Fowler has had problems with the popular Dynesys device, including loosening screws.
Though Dr. Fowler has only completed one case with the TOPS System, he recognizes that providing stability while preserving motion with a device that will stand the test of time is ideal.
Dr. Steve DeLuca
Dr. Steve DeLuca and his team at PinnacleHealth West Shore Hospital in Pennsylvania are performing a branch of the FDA-approved TOPS clinical trial. The trial is for patients with lumbar spinal stenosis and degenerative spondylolisthesis.
As a five-year study, this trial will help Dr. DeLuca and his team observe how the TOPS System can prevent degeneration in adjacent levels by preserving spinal motion. Dr. DeLuca notes that he’s particularly excited about the TOPS implant because it acts like a knee or hip replacement by replacing the joints of the lumbar spine.