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Annular Closure Device for Slipped Disc
N/A
Waitlist Available
Research Sponsored by Intrinsic Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Radiculopathy (with or without back pain) with a positive Straight Leg Raise (0 - 60 degrees)
At least six (6) weeks of failed, conservative treatment prior to surgery, including physical therapy, use of anti-inflammatory medications at maximum specified dosage and/or administration of epidural/facet injections.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will study a new device to help close up the hole left by a lumbar disc removal surgery.
Who is the study for?
This trial is for adults aged 18-75 with a slipped disc or intervertebral disc displacement between L4 and S1 who've tried other treatments like physical therapy or medications without success. They must have certain MRI findings, leg pain, and be able to follow the study plan. Exclusions include active infections, severe medical conditions like bone disease or diabetes, previous lumbar surgery at the same level, pregnancy plans within two years, involvement in spinal litigation or another study.Check my eligibility
What is being tested?
The trial is testing an annular closure device as an addition to primary lumbar limited discectomy compared to discectomy alone. It's a prospective (looking forward), single-arm (one treatment group), multicenter study assessing if this device can improve outcomes after surgery for those with specific types of spinal disc herniations.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include discomfort at the implant site, infection risk from surgery, possible nerve damage leading to numbness or weakness in legs/feet and reactions related to materials used in the annular closure device such as titanium.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experience leg pain when my leg is lifted straight up.
Select...
I have tried physical therapy, anti-inflammatory medications, or injections for 6 weeks without improvement.
Select...
I have a confirmed disc herniation in my lower back compressing a nerve.
Select...
I am between 18 and 75 years old and my bones have stopped growing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse events
Back pain severity (0-100 VAS score)
Blood loss
+13 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Annular closure deviceExperimental Treatment1 Intervention
Single arm study; all patients treated with an annular closure device
Find a Location
Who is running the clinical trial?
Intrinsic TherapeuticsLead Sponsor
7 Previous Clinical Trials
1,059 Total Patients Enrolled
David H Kim, MDStudy ChairNew England Baptist Hospital
5 Previous Clinical Trials
754 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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