Clinical trial: Barricaid EU Post Market Study for Primary Lumbar Disc Herniation (NCT01534065)

Eligibility 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.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 57-year-old man comes to the emergency department due to constipation.  His last bowel movement was 2 days ago. He complains of spending about 30 minutes once attempting to defecate. He also has lower back pain.  There is no history of trauma. The pain is not relieved with over-the-counter pain medications.  His vital signs are within normal limits.  Examination shows low back pain that is worse with back flexion and raising of the legs; it radiates into his left leg.  Pinprick in the perianal area does not cause rapid contraction of the anal sphincter.  The rest of the neurologic examination is normal. He is suspected of Cauda Equina syndrome and referred to a spinal MRI.

Patient description (patient's own words): I'm a 57 year-old-man, and I had to go to the ER because I couldn't go defecate. My last trip to the toilet was 2 days ago, and I tried too many times, during 30 min, to get my poop to get out. I also have terrible lower back pain. The doctor did not notice any trauma. I tried to get the pain away using over-the-counter medications, but it simply did not work! Back in the ER my vitals were normal. My pain was even more intense with back flexion, and when I raised my legs, it radiated into my left leg. The doctor did an anus exam where he had to pinch it and it was not reacting! However the rest of my neurologic exam was normal. The doctor suspects a Cauda Equina syndrome and referred me to a spinal MRI.

Does the patient match the trial criteria? Contradiction