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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.

Must not have

Subject has significant peripheral neuropathy, defined as a subject with Type I or Type II diabetes or similar systemic metabolic condition causing decreased sensation in a stocking-like or non-radicular and non-dermatomal distribution in the lower extremities.

Any metabolic bone disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I experience leg pain when my leg is lifted straight up.

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I have tried physical therapy, anti-inflammatory medications, or injections for 6 weeks without improvement.

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I have a confirmed disc herniation in my lower back compressing a nerve.

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I am between 18 and 75 years old and my bones have stopped growing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have diabetes or a similar condition causing decreased sensation in my legs.

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I have a bone condition that affects how my bones use minerals.

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I need spinal surgery, not just a discectomy, for my leg/back pain.

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I have had tuberculosis within the last 3 years or have it currently.

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I currently have an infection.

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I have been diagnosed with active hepatitis, AIDS, or HIV.

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I am considered morbidly obese based on my BMI or weight.

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My spine condition involves a significant slip of one vertebra over another.

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I need a spine DEXA because my bone density score is very low.

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I have scoliosis with a curve greater than 10 degrees.

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I have been on steroids for more than a month in the past year.

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I have had one or more broken bones in my spine or hip.

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I have damage to my lower spine caused by injury, cancer, infection, or a metabolic condition.

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I am pregnant or planning to become pregnant soon.

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I have had surgery on a specific lower back vertebra.

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I have cauda equina syndrome or problems controlling my bladder or bowel due to nerve issues.

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I have diabetes that requires insulin treatment.

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I have severe blood flow problems in my legs.

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I have been diagnosed with rheumatoid arthritis or another autoimmune disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse events

Back pain severity (0-100 VAS score)

Blood loss

+13 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Annular closure deviceExperimental Treatment1 Intervention

Single arm study; all patients treated with an annular closure device

0 / 23Eligibility criteria met

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

~10 spots leftby Jan 2026

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