Thirty centers across the United States, including a center near you, UPMC West Shore Pinnacle in Harrisburg, are enrolling a limited number of selective patients.
You may qualify for this FDA trial:
Have single-level lumbar spondylolisthesis and spinal stenosis
Have not had a previous spine surgery
Don’t suffer from scoliosis or osteoporosis
Have Medicare or other medical insurance
What do I Gain by Participating?
If you have been indicated for a lumbar fusion, participating in this trial gives you a 67% chance of getting the innovative TOPS™ System motion device and a 33% chance of the best fusion treatment.
By participating in the TOPS study, you will experience the best care possible. Whether you receive the innovative TOPS motion device or the best fusion procedure, the surgical staff and the surgeons at the Orthopedic Institute of Pennsylvania will provide the highest level of care.
You will be seen by your surgeon and nursing staff prior to surgery, during your hospital stay, and at periodic visits until the 5th year anniversary of your surgery. You will be kept abreast of your progress.
What is the TOPS System?
The TOPS™ System – The Alternative to Fusion
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 L4-L5, L3-L4, or L2-L3) following the decompression to alleviate pain stemming from a single-level spinal stenosis and degenerative spondylolisthesis. Spinal stenosis is a narrowing of the spinal canal, which causes a pinching of nerve roots that extend from the spine to the legs. Degenerative spondylolisthesis refers to an abnormal slip of one spinal vertebra in relation to another that causes pain in the lower back and legs.
Providing More Flexibility in the Treatment of Spinal Stenosis
Pain relief is achieved when your surgeon removes the bone elements that press on your nerves. Upon completing the 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, surgeons allow 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).
Meet Your Spine Expert
- Performing complex spine surgery for over a decade.
- Sees patients at Orthopedic Institute of Pennsylvania at Camp Hill, and operates at UPMC West Shore Pinnacle Hospital in Harrisburg.
- Received his bachelor’s degree from Franklin and Marshall College, where he was an All-American football player. He earned a Doctor of Osteopathic Medicine and Master of Science degree from Philadelphia College of Osteopathic Medicine.
- Recipient of the 2007 Bob Green, D.O. Memorial Award, given annually to the D.O. orthopedic surgeon who achieves the highest combined score in the written and oral board certification examination.Certified by the American Osteopathic Board of Orthopedic Surgery and member of the American Academy of Osteopathic Surgeons, American Osteopathic Academy of Orthopedics, American Osteopathic Association, Pennsylvania Osteopathic Medical Association, North American Spine Society, Society for Minimally Invasive Spine Surgery, International Society for the Advancement of Spine Surgery, and Pennsylvania Orthopedic Society.
Contact Hollie Brown at:
(717) 761-5530 or [email protected]
to make an appointment with Dr. DeLuca
How Does the Surgeon Decide if I Qualify?
Upon reviewing your MRI, CT scan, and/or X-rays, your surgeon may diagnose you with spinal canal narrowing (stenosis) and a slipped disc (spondylolisthesis), and recommend surgery to open your nerve pathways. After assessing these factors and others that are required according to the FDA study criteria (e.g., single-level indication, no severe scoliosis, etc.), the surgeon will consult with you and allow you to decide if you want to participate in the study. If you decide to enroll in the study, you will either receive the TOPS device or spinal fixation. Two-thirds of patients will receive the TOPS and one-third will undergo the gold-standard fusion procedure.
How are Patients Randomized?
If you choose to participate and you qualify for this study, you will not be able to choose the group to which you are assigned. Your treatment assignment will be made by randomization, a method similar to tossing a coin. You will have a two in three chance of receiving the TOPS System (67%) and a one in three chance of receiving posterior lumbar spinal fusion (33%).
Mark enrolled in the study and randomized to a fusion
Mark is a participant in the TOPS clinical trial and would recommend it to anyone. Hear his story.
How is my Pain Relief and Recovery?
Pain relief is achieved when the surgeon removes the bone elements that press on your nerves. This procedure is also known as a “decompression”. After the decompression, the surgeon will either implant pedicle screws and fusion rods or pedicle screws and the TOPS to replace the diseased skeletal structures and stabilize the spine.
Has this Type of Surgery Ever Been Done Prior to this Clinical Trial?
What is my Commitment?
You will be evaluated at regular follow-up visits. There will be one visit 6 weeks after surgery, then other visits at 3, 6, 12, and 24 month, and annually thereafter until the study ends. During these visits one or more medical professionals will evaluate your physical condition. Enrollment in this study requires that you complete all follow-up visits in a timely manner. This is an agreement that you make with the physician and the sponsor of the study. No matter what your assignment group is, your follow-up data is very important to help determine the safety and efficacy of the TOPS device.
I’m liking the fact that I’m part of the study
Mark describes the advantages of being more apprised of his clinical progress through regular ongoing surgeon check-ups.
What are the Benefits and Risks Associated with the Clinical Trial and Surgical Procedure?
The risks are the same as those associated with fusion spine surgery. If you are interested in enrolling in the study, you will be asked to sign an Informed Consent form that contains a list of potential adverse events. The physician conducting this clinical trial will have a detailed discussion with you prior to enrollment in the study. This trial is being conducted under the auspices of FDA. Additionally the hospital’s associated Institutional Review Board has approved this clinical trial.
What is the Goal of the TOPS Clinical Study?
Physicians will be comparing the TOPS to lumbar fusion in a randomized clinical trial. This pivotal study is designed to determine the safety and efficacy of the TOPS implant, after which the U.S. Food and Drug Administration (FDA) will determine if the device will become available to the general public. In the IDE approval, FDA designated the TOPS System as a Category B device and CMS has since granted pre-approval for the coverage of routine care and services, including the device, furnished to Medicare beneficiaries enrolled into this trial.
Indications For Use of the TOPS™ System
The TOPS System is indicated for patients between 35 and 80 years of age suffering from neurogenic claudication resulting from degenerative spondylolisthesis up to Grade I with moderate to severe lumbar spinal stenosis and either the thickening of the ligamentum flavum or scaring facet joint capsule. Degenerative spondylolisthesis refers to an abnormal alignment with slippage of one spinal vertebra in relation to another that can cause pain in the lower back and legs. This condition can often occur concomitantly with a narrowing of the spinal canal, compression of the traversing nerves, and also increased abnormal movement of the two vertebrae in relation to each other. The TOPS™ System is intended to provide stabilization following decompression in skeletally mature patients with disease at one level from L2 to L5 who have not achieved sufficient symptom relief with prior conservative care.
TOPS Surgery was the Right Decision for Me
Bonnie explains her thoughts and the treatments she pursued before undergoing spinal surgery.
Other Sites Across the US
Texas Back Institute
Baylor Scott and White
Eisenhower Medical Center
Dignity St. Mary’s
University of Colorado
St. David’s Medical Center
Southern Oregon Orthopedics
UPMC West Shore Pinnacle
Cleveland Clinic Foundation
U of Penn Neurosurgery
Allegheny Health Network
Lenox Hill Northwell
Brigham & Women’s
Sibley Johns Hopkins
Georgetown Medical Center
Carolina NeuroSurgery & Spine
St. Vincent’s Jacksonville
Florida Spine Institute
Wisconsin Bone & Joint