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Lumbar Disc HerniationNCT01534065

Barricaid EU Post Market Study for Primary Lumbar Disc Herniation

A study testing Barricaid in people with Lumbar Disc Herniation, run by Intrinsic Therapeutics.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this multi-center post marketing surveillance study is to monitor the safety and performance of the Barricaid® ARD when used to surgically reconstruct the anulus of the L1 - S1 spinal disc. Read more about this study

Who is it for?
Ages 18 to 75 years, men only
Conditions the study is for
Lumbar Disc Herniation
What is being tested?
Barricaid
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
No sites listed yet
Study dates
Apr 2009to Mar 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 to 75 years old (male or female).
  • Patients with posterior or posterolateral disc herniations at one or two levels between L1 and S1 with radiographic confirmation of neural compression using CT and/or MRI.
  • 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.;
  • Minimum posterior disc height of 3mm at the index level(s).
  • Lower back pain and/or sciatica with or without spinal claudication.
  • Oswestry Questionnaire score of at least 40/100 at baseline.
  • VAS leg pain of at least 40/100 at baseline.

Who cannot join

  • Spondylolisthesis Grade II or higher
  • Subject requires uni or bilateral facetectomy to treat leg/back pain
  • Subject has back or non-radicular leg pain of unknown etiology.
  • Prior fusion (with or without instrumentation), motion preservation, facetectomy or IDET surgery at the index lumbar vertebral level
  • Subject's requiring a spine DEXA (i.e., patients with SCORE of ≥ 6) with a T Score less than -2.0 at the index level.
  • Subject has clinically compromised vertebral bodies at the index level(s) due to any traumatic, neoplastic, metabolic, or infectious pathology.
Show all 25Show fewer
  • Subject has sustained pathologic fractures of the vertebra or multiple fractures of the vertebra or hip.
  • Subject has scoliosis of greater than ten (10) degrees (both angular and rotational).
  • Any metabolic disease bone disease that has not been stabilized for at least three months (e.g., Paget's disease, osteomalacia, osteogenesis imperfecta, thyroid and/or parathyroid gland disorder, etc.).
  • Subject has an active infection either systemic or local.
  • Subject has cauda equine syndrome or neurogenic bowel/bladder dysfunction.
  • Subject has severe arterial insufficiency of the legs (Screening on physical examination= patients with diminution or absence of dorsalis pedis or posterior tibialis pulses. If diminished or absent by palpation, then an arterial ultrasound is required with vascular plethysmography. If the absolute arterial pressure is below 50mm of Hg at the calf or ankle level, then the patient is to be excluded) or other peripheral vascular disease).
  • Subject has significant peripheral neuropathy, patient defined as a patient 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.
  • Subject has insulin-dependent diabetes mellitus.
  • Subject is morbidly obese (defined as a body mass index >40, or weighs more than 100 lbs over ideal body weight).
  • Subject has been diagnosed with active hepatitis, AIDS, or HIV.
  • Subject has been diagnosed with rheumatoid arthritis or other autoimmune disease.
  • Subject has a known allergy to titanium, polyethylene or polyester materials.
  • Subject is pregnant or interested in becoming pregnant in the next three (3) years.
  • Subject has active tuberculosis or has had tuberculosis in the past three (3) years.
  • Subject has a history of active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no signs or symptoms of the malignancy for at least two (2) years.
  • Subject is immunologically suppressed, received steroids >1 month over the past year.
  • Currently taking anticoagulants, other than aspirin, unless the patient can be taken off the anticoagulant for surgery
  • Subject has a current chemical/alcohol dependency or significant psychosocial disturbance.
  • Subject has a life expectancy of less than three (3) years.

About this study

Official title: A Multi-center, Post Marketing Surveillance Study to Monitor the Safety and Performance of the Barricaid® ARD in the Treatment of Back and Radicular Pain Caused by Primary Lumbar Disc Herniation

The purpose of this multi-center post marketing surveillance study is to monitor the safety and performance of the Barricaid® ARD when used to surgically reconstruct the anulus of the L1 - S1 spinal disc.

Read the detailed description

The purpose of this prospective, randomized, multicenter study is to demonstrate the superiority of the Barricaid® when used as an adjunct to a primary lumbar limited discectomy (as described by Spengler), to limited discectomy alone, with regard to preventing reherniation and the recurrence of pain or dysfunction. Patients, ages 21 - 75, will have, in part, a positive straight leg raise (or positive femoral stretch, as appropriate), MRI confirmation of a disc herniation, and minimum Oswestry and VAS leg scores of 40 out of 100 to qualify for this study. Additional patient criteria can be found in the inclusion/exclusion criteria section.

Superiority of the Barricaid relative to limited discectomy alone will be based on a comparison of overall success rates of the Barricaid and a concurrent group (randomized) of control patients treated by primary lumbar limited discectomy at select European (approximately 15-20) sites.

This study has two co-primary endpoints. Success of the study will be based on the Barricaid population achieving statistical superiority over the concurrently randomized non-implanted limited discectomy population at 2 years.

Being tested
Barricaid
Keywords
Hernia, Intervertebral Disk Displacement, Pathological Conditions, Anatomical, Spinal Diseases, Bone Diseases, Musculoskeletal Diseases
Medical subject headings
Intervertebral Disc Displacement, Hernia, Pathological Conditions, Anatomical, Spinal Diseases, Bone Diseases, Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BarricaidDevice

    Implanted intra-operatively during discectomy

Study groups in NCT01534065
Study groupRoleWhat they receive
BarricaidExperimentalCE Marked Device
Receives: Device: Barricaid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient function as measured on Oswestry Disability Index (ODI)

    15-point reduction in ODI at 24-month visit relative to baseline

    Measured: 24 months

  2. Disc height maintenance as measured from standing x-rays

    75% maintenance at 2 years relative to pre-op, measured by independent radiologist, (reference: Yorimitsu, et al, Spine 2001)

    Measured: 24 months

  3. Clinically symptomatic recurrent herniation at the index level, confirmed by imaging

    Performed at 24 months by the Investigator.

    Measured: 24 months

  4. Migration of the bone anchor posteriorly into the epidural space

    Radiographic imaging taken to ensure no migration of the device. Assessment made by the Investigator and Radiographic Core lab.

    Measured: 24 months

  5. Removal or revision of the implant

    Any removal or revision of the implant will be measured as a safety outcome.

    Measured: 24 months

  6. Supplemental fixation applied at the treated level

    Any supplemental fixation applied at the treated level will be tracked.

    Measured: 24 months

Secondary outcomes (5)

  1. Back Pain on Visual Analog Scale (VAS)

    Back pain on VAS will be tracked.

    Measured: 24 months

  2. Leg Pain on Visual Analog Scale (VAS)

    Leg pain assessment will be tracked. Patient reported outcome.

    Measured: 24 months

  3. Quality of life on SF36

    Quality of life on SF36 will be tracked. Patient reported outcome.

    Measured: 24 months

  4. Comparison of neurological symptoms on clinical examination, relative to baseline

    Patient will have the following examinations: straight leg raising, deep tendon reflexes, forward bend, motor strength examination (hip flexors, knee extensors, tibialis, long toe extensors), and sensory (light touch, pin prick, or vibration)

    Measured: 24 months

  5. Frequency of AE's

    Frequency of AE's reported throughout the study will be tracked and analyzed at the 24 month visit.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2012 (estimated)
  2. Study startApr 2009
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01534065
Sponsor's protocol ID
BARD-CP-001
Status last verified
Mar 2022
First submitted
4 Jan 2012
Last updated
8 Apr 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Lequin MB, Barth M, Thome C, Bouma GJ. Primary limited lumbar discectomy with an annulus closure device: one-year clinical and radiographic results from a prospective, multi-center study. Korean J Spine. 2012 Dec;9(4):340-7. doi: 10.14245/kjs.2012.9.4.340. Epub 2012 Dec 31.

    PubMed 25983843

  • Bouma GJ, Barth M, Ledic D, Vilendecic M. The high-risk discectomy patient: prevention of reherniation in patients with large anular defects using an anular closure device. Eur Spine J. 2013 May;22(5):1030-6. doi: 10.1007/s00586-013-2656-1. Epub 2013 Feb 3.

    PubMed 23377540

Questions about this trial

What is this clinical trial studying?

A study testing Barricaid in people with Lumbar Disc Herniation, run by Intrinsic Therapeutics.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient function as measured on Oswestry Disability Index (ODI) (time frame: 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01534065, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.

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