Barricaid EU Post Market Study for Primary Lumbar Disc Herniation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intrinsic Therapeutics
ClinicalTrials.gov Identifier:
NCT01534065
First received: January 4, 2012
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Lumbar Disc Herniation
Device: Barricaid
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Intrinsic Therapeutics:

Primary Outcome Measures:
  • Patient function as measured on Oswestry Disability Index (ODI) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    15-point reduction in ODI at 24-month visit relative to baseline

  • Disc height maintenance as measured from standing x-rays [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    75% maintenance at 2 years relative to pre-op, measured by independent radiologist, (reference: Yorimitsu, et al, Spine 2001)

  • Clinically symptomatic recurrent herniation at the index level, confirmed by imaging [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Performed at 24 months by the Investigator.

  • Migration of the bone anchor posteriorly into the epidural space [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Radiographic imaging taken to ensure no migration of the device. Assessment made by the Investigator and Radiographic Core lab.

  • Removal or revision of the implant [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Any removal or revision of the implant will be measured as a safety outcome.

  • Supplemental fixation applied at the treated level [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Any supplemental fixation applied at the treated level will be tracked.


Secondary Outcome Measures:
  • Back Pain on Visual Analog Scale (VAS) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Back pain on VAS will be tracked.

  • Leg Pain on Visual Analog Scale (VAS) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Leg pain assessment will be tracked. Patient reported outcome.

  • Quality of life on SF36 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Quality of life on SF36 will be tracked. Patient reported outcome.

  • Comparison of neurological symptoms on clinical examination, relative to baseline [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    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)

  • Frequency of AE's [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Frequency of AE's reported throughout the study will be tracked and analyzed at the 24 month visit.


Enrollment: 45
Study Start Date: April 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Barricaid
CE Marked Device
Device: Barricaid
Implanted intra-operatively during discectomy

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 to 75 years old (male or female).
  2. 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.
  3. 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.;
  4. Minimum posterior disc height of 3mm at the index level(s).
  5. Lower back pain and/or sciatica with or without spinal claudication.
  6. Oswestry Questionnaire score of at least 40/100 at baseline.
  7. VAS leg pain of at least 40/100 at baseline.

Exclusion Criteria:

  1. Spondylolisthesis Grade II or higher
  2. Subject requires uni or bilateral facetectomy to treat leg/back pain
  3. Subject has back or non-radicular leg pain of unknown etiology.
  4. Prior fusion (with or without instrumentation), motion preservation, facetectomy or IDET surgery at the index lumbar vertebral level
  5. 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.
  6. Subject has clinically compromised vertebral bodies at the index level(s) due to any traumatic, neoplastic, metabolic, or infectious pathology.
  7. Subject has sustained pathologic fractures of the vertebra or multiple fractures of the vertebra or hip.
  8. Subject has scoliosis of greater than ten (10) degrees (both angular and rotational).
  9. 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.).
  10. Subject has an active infection either systemic or local.
  11. Subject has cauda equine syndrome or neurogenic bowel/bladder dysfunction.
  12. 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).
  13. 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.
  14. Subject has insulin-dependent diabetes mellitus.
  15. Subject is morbidly obese (defined as a body mass index >40, or weighs more than 100 lbs over ideal body weight).
  16. Subject has been diagnosed with active hepatitis, AIDS, or HIV.
  17. Subject has been diagnosed with rheumatoid arthritis or other autoimmune disease.
  18. Subject has a known allergy to titanium, polyethylene or polyester materials.
  19. Subject is pregnant or interested in becoming pregnant in the next three (3) years.
  20. Subject has active tuberculosis or has had tuberculosis in the past three (3) years.
  21. 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.
  22. Subject is immunologically suppressed, received steroids >1 month over the past year.
  23. Currently taking anticoagulants, other than aspirin, unless the patient can be taken off the anticoagulant for surgery
  24. Subject has a current chemical/alcohol dependency or significant psychosocial disturbance.
  25. Subject has a life expectancy of less than three (3) years.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Intrinsic Therapeutics
ClinicalTrials.gov Identifier: NCT01534065     History of Changes
Other Study ID Numbers: BARD-CP-001
Study First Received: January 4, 2012
Last Updated: March 5, 2014
Health Authority: Germany: Ethics Commission
Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Intrinsic Therapeutics:
Hernia
Intervertebral Disk Displacement
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

Additional relevant MeSH terms:
Hernia
Intervertebral Disk Displacement
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 17, 2014