| Eligibility |
Inclusion Criteria:
1. Age 21 to 75 years old and skeletally mature (male or female).
2. Patients with posterior or posterolateral disc herniations at one level between L1 and
S1 with radiographic confirmation of neural compression using MRI. [Note:
Intraoperatively, only patients with an annular defect (post discectomy) between 4mm
and 6mm tall and 6mm and 10mm wide shall qualify.]
3. Radiculopathy (with or without back pain) with a positive Straight Leg Raise (0 - 60
degrees)22 (L45, L5S1) or Femoral Stretch Test (L12, L23, L34)
4. Oswestry Questionnaire score of at least 40/100 at baseline.
5. VAS leg pain (one or both legs) of at least 40/100 at baseline.
6. Psychosocially, mentally and physically able to fully comply with the clinical
protocol and willing to adhere to follow-up schedule and requirements.
7. Minimum posterior disc height of 5mm at the index level.
Exclusion Criteria:
1. Spondylolisthesis Grade II or higher (25% slip or greater).
2. Subject requires spinal surgery other than a discectomy (with or without laminotomy)
to treat leg/back pain (scar tissue and osteophyte removal is allowed).
3. Subject has back or non-radicular leg pain of unknown etiology.
4. Prior surgery at the index lumbar vertebral level.
5. Subject requiring a spine dual energy x-ray absorptiometry (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.
6. Subject has clinically compromised vertebral bodies in the lumbosacral region 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 bone disease.
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 or other peripheral vascular
disease. (Screening on physical examination for 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.)
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 active tuberculosis or has had tuberculosis in the past three (3) years.
19. 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.
20. Subject is immunologically suppressed, received steroids >1 month over the past year.
21. Currently taking anticoagulants, other than aspirin, unless the patient can be taken
off the anticoagulant for surgery.
22. Subject has a current chemical/alcohol dependency or significant psychosocial
disturbance.
23. Subject has a life expectancy of less than three (3) years.
24. Subject is currently involved in active spinal litigation.
25. Subject is currently involved in another investigational study.
26. Subject is incarcerated.
27. Patients will be divided into two arms (small- and large-defect) based on the width of
their annular defect as measured intra-operatively. Patients with defects <6mm in
width will be in the "small defect" arm; patients with defects =6mm in width will be
in the "large defect" arm. Each arm will be capped at 50 patients. Once 50 patients
are accrued in one arm, subsequent patients who meet the criteria for that arm will be
excluded. Enrollment will continue until both arms are filled.
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