Motion-Preserving Surgery · Naples, FL

Spondylolisthesis TOPS™ Failures: What the Data Actually Shows

By Dr. Mark B. Frenkel, MD, MA, FAANS, FCNS — Board-Certified Neurosurgeon & Spine Surgeon, Neuroscience and Spine Associates (NASA), Naples, FL

Patients researching spondylolisthesis TOPS™ failures before surgery are doing exactly the right thing. TOPS is a newer technology than spinal fusion — it doesn’t have decades of track record behind it — and a healthy dose of skepticism toward any newer surgical device is appropriate, not paranoid.

I’m not going to dodge this question or bury it in reassurance. I’m going to show you the actual numbers from the FDA trial, including the reoperations and device-related complications that did occur, because I think a surgeon who only shows you the good news isn’t giving you real informed consent.

By the end of this article, you’ll know the real failure and reoperation rates, how they compare to traditional fusion in the same trial, and what actually causes TOPS™ to underperform when it does.

Why Asking About TOPS™ Failures Is the Right Instinct

The TOPS™ Posterior Arthroplasty System received FDA premarket approval in June 2023, with a superiority-to-fusion claim — a genuinely rare designation. But “FDA-approved” and “flawless” are not the same thing, and no responsible surgeon should imply otherwise.

I’ve written before about being skeptical of unproven marketing claims in spine surgery — not every new technology deserves blind trust. TOPS™ earns its place in my practice because it has real randomized trial data behind it, not because it’s newer or trendier than fusion. Let’s look at exactly what that data shows.

What “Failure” Actually Means With a Facet Arthroplasty Device

“Failure” gets used loosely online, and it’s worth separating out what it actually refers to before looking at numbers:

• Device-related failure: A mechanical problem with the implant itself — screw loosening, component breakage, or misplacement
• Clinical failure: The surgery doesn’t adequately relieve pain or restore function, even with a mechanically intact device
• Reoperation for any reason: The broadest category — includes device-related issues, but also additional decompression, injections, or unrelated findings

These are very different in severity, and lumping them together — which a lot of alarmist content online does — obscures more than it reveals.

The Actual TOPS™ Failure and Reoperation Rates

Here are the real figures from the FDA investigational device exemption trial, the same trial that led to TOPS™’s approval:

A 1-year interim safety analysis of 153 TOPS™ patients found postoperative complications in 7.2%, with 5.9% undergoing some form of reoperation and just 0.6% specifically for device-related failure — in that single case, bilateral pedicle screw loosening. At 3-year follow-up across the full trial, 14.0% of TOPS™ patients required reoperation or a lumbar injection, which sounds significant until you see what it’s being compared against.

How TOPS™’s Failure Profile Compares to Fusion’s

This is the number that actually matters for decision-making: in that same 3-year randomized trial, the fusion group’s reoperation-or-injection rate was 25.3%, significantly higher than the 14.0% rate in the TOPS™ group. Composite clinical success at 36 months was also higher for TOPS™ — 76.0% versus 56.8% for fusion.

Fusion has its own well-documented failure modes that don’t get discussed nearly as often as TOPS™’s: adjacent segment disease occurs at a rate of roughly 2 to 3% per year after fusion, affecting an estimated 20 to 25% of fusion patients within a decade. In the TOPS™ trial, zero reoperations in the arthroplasty group at one year were for adjacent segment disease — the single most common reason fusion patients end up back in the operating room.

So the honest, myth-busting answer to “does TOPS™ fail” is: yes, sometimes, like every spine procedure. But in the only head-to-head randomized data we have, it fails less often than the fusion alternative it’s most often compared against.

What Actually Causes TOPS™ to Fail When It Does

When TOPS™ underperforms, it’s usually one of two things — a mechanical issue or a candidacy issue — and they call for very different lessons.

• Mechanical causes: Pedicle screw loosening, screw misplacement, or, in one early reported case, a damaged polycarbonate urethane component. These are rare and, notably, none in the published trial data involved spontaneous fusion or progression of the spondylolisthesis itself.
• Candidacy causes: TOPS™ is FDA-indicated specifically for grade I degenerative spondylolisthesis with stenosis at L2 through L5. Using it outside that indication — higher-grade slips, multilevel disease, or significant baseline instability — is where a mismatch between device and pathology, not the device itself, produces a poor outcome.

In my experience, most disappointing outcomes with any spinal implant trace back to patient selection more than the hardware. That’s true of TOPS™, and it’s equally true of traditional fusion.

How I Reduce Failure Risk in My Patients

I hold every TOPS™ candidate to the same criteria the FDA trial used: grade I degenerative spondylolisthesis with stenosis, a specific level range, and a documented history of at least six months of failed conservative treatment. I don’t stretch the indication to fit a patient who wants to avoid fusion if their anatomy doesn’t genuinely support it.

For surgical placement itself, I use the augmented reality intraoperative navigation system I was the first surgeon to bring into practice — designed to reduce exactly the kind of screw misplacement that accounts for a meaningful share of device-related complications in the published data.

TOPS™ as a Fix for a Failed Fusion

Here’s a detail that rarely makes it into “TOPS™ failures” search results: TOPS™ itself has been used successfully as a revision option to treat adjacent segment disease after a prior fusion has already failed. A published case report described a patient with a previously fused segment developing new pain and stenosis at an adjacent level, who was then treated with TOPS™ rather than extending the fusion further — with significant pain relief and functional recovery.

That flips part of the “failure” conversation: for some patients, TOPS™ isn’t the risk to worry about — it’s the option that addresses someone else’s fusion failure.

What I Tell Patients Before They Choose TOPS™

Before I recommend TOPS™ to any patient, I walk through this honestly:

1. Your specific grade, level, and imaging findings — whether you actually fit the FDA-studied population
2. The real reoperation rate data from the trial, not a marketing summary of it
3. What a device-related complication would realistically involve if it occurred
4. Why CemLIF™, my rod-less fusion technique, might be the better fit instead, if your anatomy calls for true fusion rather than motion preservation

If you don’t fit the TOPS™ indication, I’ll tell you that directly rather than trying to make your case fit the technology I’d prefer to use.

Frequently Asked Questions

The Bottom Line

Spondylolisthesis TOPS™ failures are real, documented, and worth understanding before surgery — and the honest data shows a device that fails less often, by the measures that matter most, than the fusion it’s most commonly compared against. The right question isn’t whether TOPS™ can fail; it’s whether you’re the right anatomical candidate for it in the first place.

If you’re weighing TOPS™ against fusion and want a straightforward read on your candidacy, I’d encourage you to reach out. You can call my Naples office at (239) 649-1662 or schedule a consultation online. If you’re traveling from out of state or internationally, ask about our Concierge Spinal Surgery Program — we can review your imaging by telehealth first.