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.
