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Spinal Implant

TOPS vs TLIF Surgery for Spinal Stenosis

N/A
Waitlist Available
Research Sponsored by Premia Spine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must demonstrate at a single level to be treated (L2/3, L3/4 or L4/5) all three of the following: Degenerative spondylolisthesis or retrolisthesis up to Grade I, at least moderate lumbar spinal stenosis, thickening of the ligamentum flavum and/or scarring of the facet joint capsule
Neurogenic claudication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is comparing two different surgeries to see which is more effective in treating lumbar spinal stenosis, Grade 1 spondylolisthesis, and thickening of the ligamentum flavum.

Who is the study for?
This trial is for adults aged 35-80 with moderate lumbar spinal stenosis, Grade 1 spondylolisthesis or retrolisthesis, and specific ligament or joint capsule issues. Participants must have had unsuccessful non-surgical treatments for at least six months and experience significant leg pain (VAS score ≥40/100) and disability (ODI score ≥40/100). Exclusions include certain infections, allergies to implant materials, previous lumbar surgeries with instrumentation, osteoporosis, active cancer or hepatitis, immunosuppression conditions, substance dependencies including smoking, pregnancy intentions during the study period.Check my eligibility
What is being tested?
The trial compares the TOPS System's effectiveness against TLIF in stabilizing a single lumbar level after surgical decompression. It targets patients with specific back conditions who haven't improved with conservative treatment. Success is measured by patient-reported outcomes improvement without major device-related complications.See study design
What are the potential side effects?
Potential side effects may include reactions to implant materials like PEEK or titanium such as inflammation or allergic responses; complications from surgery like infection; mechanical failure of the device leading to additional surgeries; nerve damage resulting in numbness or weakness; and persistent pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a slipped disc, spinal narrowing, and thickened ligaments or scarred facet joints in my lower back.
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I experience leg pain from spinal nerve issues when I walk.
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I have leg pain rated at least 40 out of 100.
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I am between 35 and 80 years old.
Select...
My leg pain is worse than my lower back pain by at least 10 points.
Select...
My back pain significantly limits my daily activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Absence of any major device related adverse event
Improvement in Oswestry Disability Index (ODI)
Maintenance or improvement in Neurological status as assessed by a standard neurological exam performed by Investigator
+3 more
Secondary outcome measures
Greater range-of-motion through flexion-extension
Improvement (20 mm) in visual analogue scale (VAS) for back pain and worst leg
Reduction in physical component score on SF-12

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TOPS SystemExperimental Treatment1 Intervention
Investigational surgical treatment using TOPS System
Group II: Transforaminal Lumbar Interbody Fusion (TLIF)Active Control1 Intervention
Control surgical treatment using interbody fusion and placement of posterolateral instrumentation

Find a Location

Who is running the clinical trial?

Premia SpineLead Sponsor
2 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Total Posterior Spine System (TOPS) (Spinal Implant) Clinical Trial Eligibility Overview. Trial Name: NCT03012776 — N/A
Lumbar Spinal Stenosis Research Study Groups: TOPS System, Transforaminal Lumbar Interbody Fusion (TLIF)
Lumbar Spinal Stenosis Clinical Trial 2023: Total Posterior Spine System (TOPS) Highlights & Side Effects. Trial Name: NCT03012776 — N/A
Total Posterior Spine System (TOPS) (Spinal Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03012776 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research encompass elderly individuals over 75 years of age?

"Patients aged between 35 and 80 are the only individuals that meet the specifications of this trial. Seperately, 3 additional trials have been designed for those under 18 while another 91 studies cater to seniors over 65 years old."

Answered by AI

In which geographic regions is this research project accessible?

"This medical trial, which requires patient recruitment, is taking place in 37 distinct locations. A few of these sites include Physicians Regional Medical Center (Naples), Orthopaedic Associates (Bellaire) and Univ. of Cincinnati Medical Centre (Cincinnati)."

Answered by AI

Who meets the criteria for inclusion in this research endeavor?

"This medical experiment is seeking 305 individuals aged between 35 and 80, who suffer from lumbar discomfort. To be admitted to the trial, patients must fulfill these criteria: demonstrate affliction at a single level (L2/3, L3/4 or L4/5); had unsuccessful conservative treatment for six months; leg pain with VAS of 40 points minimum; ODI score higher than 40 points; lower back ache with VAS rating less than Worst Leg VAS score."

Answered by AI

Does this research endeavor presently have any openings?

"As per the details posted on clinicaltrials.gov, this medical trial is no longer recruiting patients at this time. It was initially submitted to the website in July 2017 and last modified on September 26th 2022; however, 92 other studies are currently searching for potential participants."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
What site did they apply to?
Adventist Health Glendale
St. Mary's Medical Center, Spine Center
Lenox Hill Hospital
Other
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Adventist Health Glendale: < 48 hours
Average response time
  • < 2 Days
~40 spots leftby Mar 2025