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TOPS vs TLIF Surgery for Spinal Stenosis
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.I have leg pain rated at least 40 out of 100.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.
- Group 1: TOPS System
- Group 2: Transforaminal Lumbar Interbody Fusion (TLIF)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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)."
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Adventist Health Glendale: < 48 hours
Average response time
- < 2 Days
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