A Post Marketing Surveillance Study

• Register: ClinicalTrials.gov
• Last refreshed on: 25 March 2024
• Main ID: NCT03366779
• Date of registration: 28/11/2017
• Prospective Registration: Yes
• Primary sponsor: Intrinsic Therapeutics
• Public title: A Post Marketing Surveillance Study 6MM
• Scientific title: A Post Marketing Surveillance Study To Monitor The Early Safety And Performance Of The BARRICAID® Anular Closure Device In The Treatment Of Radicular Pain Caused By Primary Lumbar Disc Herniation
• Date of first enrolment: January 16, 2018
• Target sample size: 20
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03366779
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Belgium, Germany

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age 18 to 75 years old (male or female).

- Patients with posterior or posterolateral disc herniations at one level 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, or requires
immediate surgery to prevent permanent disability.

- Minimum posterior disc height of 5mm 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.

- Psychosocially, mentally and physically able to fully comply with the clinical
protocol and willing to adhere to follow-up schedule and requirements.

Exclusion Criteria:

- 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 surgery at the index lumbar level.

- Subject requiring a spine DEXA (i.e., patients with SCORE of = 6) with a T Score less
than -2.0 at the index level. For patients with a herniation at L5/S1, the average T
score of L1-L4 shall be used.

- 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 equina 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 two (2) 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.

- Subject is currently involved in another investigational study.

- Subject is incarcerated.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Annular Disc Tear

Annular Tear of Lumbar Disc

Lumbar Disc Herniation

Intervention(s)

Device: 6mm annular closure device

Primary Outcome(s)

Device stability [Time Frame: 3 months post implantation]

Secondary Outcome(s)

Visual Analog scale - back pain [Time Frame: Through 24Month post implantation]

Oswestry Disability Index [Time Frame: Through 24Month post implantation]

Device condition, reoperation at index level and long term performance [Time Frame: Through 24Month post implantation]

Visual Analog Scale - leg pain [Time Frame: Through 24Month post implantation]

Secondary ID(s)

EUBARD-CP-001-6MM

Source(s) of Monetary Support

Please refer to primary and secondary sponsors