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.
Dr. John Fowler
Dr. John Fowler discussed lumbar spinal stenosis and degenerative spondylolisthesis at the Eurospine conference. The narrowing of the lumbar spinal canal characterizes lumbar spinal stenosis. 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. 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.
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. Anekstein
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 it 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.
First FDA-Approved TOPS™ Device Implantation: Dr. Jared Ament
A behind-the-scenes glimpse as Dr. Jared Ament and the surgical team at West Hills Hospital and Medical Center in West Hills, CA, successfully performed the first FDA-approved TOPS™ device implantation, a monumental milestone for Premia Spine.
This ground-breaking achievement sets a new standard in spine health and offers an improved quality of life for those battling Spinal Stenosis and Spondylolisthesis.