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HYDRAFIL for Back Pain Due to Degenerative Disc Disease
Study Summary
This trial is testing a new treatment for back pain caused by degenerative disc disease.
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
Who is running the clinical trial?
Media Library
- You have severe compression on your cauda equina, which is the bundle of nerves at the lower end of your spinal cord.You are 22 to 80 years old.You have disc degeneration on MRI with at least one level of disc height loss.You have been experiencing lower back pain and symptoms of degenerative disc disease in your lower spine for at least 6 months.You have back pain that rates at least 4 out of 10 on a pain scale and your daily activities are limited due to the pain.Your symptoms have not improved after trying pain medication and/or physical therapy for 12 weeks.You are legally competent and able to understand the nature, scope and aim of the clinical investigation.You have been experiencing lower back pain and other symptoms of degenerative disc disease in your lower spine for at least six months.Your symptoms have not improved after trying pain medication and/or physical therapy for 12 weeks.You have had or currently have an infection in your whole body or in a specific area.You have a serious condition called severe osteoporosis or metabolic bone disease.You have a history of alcohol or drug abuse, or are currently using alcohol or drugs in a way that is harmful or addictive.You have tumors in your spine that are currently growing or causing symptoms.You are allergic or sensitive to the materials used in the implant.You have severe back pain that rates at least 4 out of 10 on a scale, and it impacts your ability to do daily activities, which is measured by the Oswestry Disability Index score of at least 30.You have certain spine conditions like spondylolysis, spondylolisthesis, spinal canal stenosis, or scoliosis with a Cobb angle greater than 20 degrees. These conditions could affect your ability to participate in the study.You have specific types of spine disc herniations or Schmorl's nodes.You have a condition called neurogenic claudication caused by spinal stenosis.You have a condition called arachnoiditis.You have lower back pain that is caused by something other than issues with your spine, or the cause of your lower back pain is unknown.You have been experiencing lower back pain and symptoms of degenerative disc disease in your lower spine for at least 6 months.Your symptoms did not improve or get better after trying pain medication and/or physical therapy for 6 months.
- Group 1: HYDRAFIL Implant
- 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 clinical trial accept participants aged 80 or above?
"This medical trial has a strict age requirement, with the minimum being 22 and the maximum being 80."
What criteria must individuals meet to participate in this research?
"This clinical trial has a limited pool of participants, with the desired age range being between 22 and 80. To be eligible to participate in this study, individuals must have intervertebral disc degeneration. The research is seeking 50 volunteers overall."
Are there still open opportunities for individuals to join this research project?
"Clinicaltrials.gov indicates that this medical trial, initially published on April 1st 2022 and recently updated on October 25th 2022, is not currently accepting patients. With the exception of this study, however, there are 62 other ongoing studies recruiting participants right now."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What questions have other patients asked about this trial?
Why did patients apply to this trial?
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Most responsive sites:
- Beam Interventional & Diagnostic Imaging: < 48 hours
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