Barricaid EU Post Market Study for Primary Lumbar Disc Herniation

NCT01534065 | Completed DMC

• 1 other identifier: BARD-CP-001
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Lumbar Disc Herniation

Keywords

Hernia; Intervertebral Disk Displacement; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Outcome Measures

Primary Outcomes (6)

• Patient function as measured on Oswestry Disability Index (ODI)

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

  24 months

• 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)

  24 months

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

  Performed at 24 months by the Investigator.

  24 months

• 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.

  24 months

• Removal or revision of the implant

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

  24 months

• Supplemental fixation applied at the treated level

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

  24 months

Secondary Outcomes (5)

• Back Pain on Visual Analog Scale (VAS)

  24 months

• Leg Pain on Visual Analog Scale (VAS)

  24 months

• Quality of life on SF36

  24 months

• Comparison of neurological symptoms on clinical examination, relative to baseline

  24 months

• Frequency of AE's

  24 months

Study Arms (1)

Barricaid

EXPERIMENTAL

CE Marked Device

Device: Barricaid

Interventions

Barricaid DEVICE

Implanted intra-operatively during discectomy

Barricaid

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Intrinsic Therapeutics: lead

Related Publications (2)

• 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.

  PMID: 25983843 RESULT

• 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.

  PMID: 23377540 RESULT

MeSH Terms

Conditions

Intervertebral Disc Displacement; Hernia; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Officials

• Claudius Thome, PhD

  University of Innsbruck, Department of Neurosurgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2012
• First Posted: February 16, 2012
• Study Start: April 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 8, 2022

Record last verified: 2022-03