A Pivotal Study of the Total Posterior Spine (TOPS™) System

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A Pivotal Study of the Total Posterior Spine (TOPS™) SystemThe human spine is a protector; it shields the spinal cord, nerve roots and several of the body's internal organs from injury. The spine also serves as a shock absorber, enabling flexibility and motion. Over time, as discs in the spine become worn, the body gives way to degenerative disc disease. While this is a normal part of the aging process, degenerative disc disease typically causes back pain and significantly limits normal movement.

For years, decompression (the removal of bone to relieve pressure and pinching of the spinal nerves) and fusion (the fusing together of two or more vertebrae) have been the standard treatments for conditions associated with degenerative disc disease. Both procedures, however, have been known to lead to further spinal degeneration after treatment. Now, a clinical trial at Penn Medicine is exploring a new spine treatment that shows promise of relieving chronic back pain with potentially fewer residual side effects than traditional fusion.

William C. Welch, MD, FACS, FICS, the current chair of the Department of Neurosurgery at Pennsylvania Hospital, discusses the goals of the clinical trial and how this new procedure option may lead to better outcomes for spine surgery patients.

What is the TOPS system?

The TOPS™ System is a mechanical implant device that replaces the bony and soft tissues removed during spinal decompression surgery. It has been clinically proven to provide pain relief and improvement in quality of life for patients living with spinal stenosis, spondylolisthesis and other diseases of the facet joint.

What are the differences between transforaminal lumbar interbody fusion (TLIF) and the TOPS system treatment?

If you have slippage between one vertebral body and another, it’s called Spondylolisthesis. This can be caused by broken bones or degenerative changes in the joints. The standard treatment for this is laminectomy and transforaminal lumbar interbody fusion (TLIF), using screws and solid rods; the screws and rods act like an internal brace and they hold the bones in position while the body achieves a solid bone union.

Fusion is a very effective treatment but it restricts motion; the two places on either side of the plate don’t move. The TOPS device, however, allows a moderate amount of movement without taking a patient through the process of getting a fusion.

By providing either fusion or TOPS, many patients will experience improvement in their leg or back pain. Both have excellent long-term pain relief scores, but fusion is believed to accelerate degenerative changes above and below the fusion, whereas the TOPS device may not do that.

What are the advantages of the TOPS system?

The TOPS System procedure stabilizes the lumbar spine, enabling patients to bend, flex, walk, and enjoy the normal activities of life, without pain. Another major potential advantage is that it’s possible, by providing some movement through the use of the TOPS system, to reduce adjacent level disease. This is not yet proven, but we believe the TOPS system may reduce the subsequent adjacent level problems (pain occurring above and below the fusion area) after surgery.

What is the purpose of the Premia Spine TOPS™ System trial?

The number one risk associated with fusion and TOPS is that the patient may have problems or experience pain, later on, above and below the fusion. The purpose of the study is to confirm the long-term benefits of TOPS. Ultimately, we want to determine whether the TOPS System is more effective than fusion at reducing those residual effects.

We will be following up with patients who receive TOPS implants for life to assess any improvement in patient reported outcomes and device related complications.

Who are good candidates for this trial?

We’re hoping to attract patients who have been offered spinal fusion but are on the fence and are interested in having an alternative option. In addition to other criteria, potential candidates for the trial must:

  • Be between 35 and 80 years of age
  • Have been diagnosed with degenerative spondylolisthesis, retrolisthesis or moderate lumbar spinal stenosis.
  • Have had at least six months of failed conservative treatment prior to surgery (e.g., physical therapy, use of anti-inflammatory medications at maximum recommended dosage; administration of epidural/facet injections and/or nerve block)

Why is this trial important and why choose Penn?

The trial is important because it’s the first and only trial of its kind that really gives patients an alternative to spinal fusion surgery. Fusion has been the standard for a long time, so people have gotten used to dealing with residual negative effects of the procedure; TOPS shows promise of reducing or removing those effects.

Penn Medicine is the only academic medical institution in the region currently offering the TOPS implant and one of only 30 hospitals nationwide to participate in the Premia Spine TOPS™ System clinical trial.

The Penn Spine Center team is actively recruiting for this trial. Learn more about this spine clinical trial by contacting: Marie Kerr: 215-829-6720 or request an appointment with a member of the Penn Spine Center team.

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