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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
Must not have
Active infections, hepatitis, AIDS, HIV, Rheumatoid arthritis, Tuberculosis, active malignancy, etc.
Spondylolisthesis greater than Grade I
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
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.
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.
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 belowSelect...
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.
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My leg pain is worse than my lower back pain by at least 10 points.
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My back pain significantly limits my daily activities.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have active infections or conditions like hepatitis, AIDS, HIV, rheumatoid arthritis, tuberculosis, or another active cancer.
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My spine condition is more severe than a minor slip (Grade I).
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I have had back surgery with hardware installed.
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My spine curvature is more than 10 degrees.
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I have a herniated disc with a free fragment.
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I have damaged vertebrae in my spine.
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I have nerve issues affecting my lower back, bowel, or bladder.
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I am not on medication that could affect healing or receiving radiation therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
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 moreSecondary 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Total Posterior Spine System (TOPS)
2017
N/A
~310
Find a Location
Who is running the clinical trial?
Premia SpineLead Sponsor
2 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have active infections or conditions like hepatitis, AIDS, HIV, rheumatoid arthritis, tuberculosis, or another active cancer.My leg pain is worse than my lower back pain.My spine condition is Grade I spondylolisthesis or retrolisthesis.I have leg pain with a score of 40 or more out of 100.I have a slipped disc, spinal narrowing, and thickened ligaments or scarred facet joints in my lower back.I tried non-surgical treatments for 6 months without success.I have a condition like osteoporosis, Paget's disease, or gout.My condition meets all required criteria for a specific spinal level treatment.My leg pain is worse than my lower back pain by at least 10 points.I experience leg pain from spinal nerve issues when I walk.My MRI shows I have moderate to severe narrowing in my lower back.I have tried non-surgical treatments for my condition for at least 6 months without success.My condition meets all required criteria at one spinal level.My back pain severely limits my daily activities.I am between 35 and 80 years old.My spine condition is more severe than a minor slip (Grade I).I have leg pain rated at least 40 out of 100.I have had back surgery with hardware installed.My spine curvature is more than 10 degrees.I have a herniated disc with a free fragment.I am between 35 and 80 years old.My spinal narrowing is due to a slipped disc or was present from birth, caused by treatment, injury, or a metabolic issue.My back pain significantly limits my daily activities.I have damaged vertebrae in my spine.I have nerve issues affecting my lower back, bowel, or bladder.I am not on medication that could affect healing or receiving radiation therapy.I have back or leg pain without a known cause.
Research Study Groups:
This trial has the following groups:- Group 1: TOPS System
- Group 2: Transforaminal Lumbar Interbody Fusion (TLIF)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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