Clinical trial NCT01534065: Barricaid EU Post Market Study for Primary Lumbar Disc Herniation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Disc Herniation
Keywords: Hernia
Intervertebral Disk Displacement
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Lead sponsor: Intrinsic Therapeutics
Sponsor class: INDUSTRY
First posted: 2012-02-16
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: The purpose of this prospective, randomized, multicenter study is to demonstrate the superiority of the Barricaid® when used as an adjunct to a primary lumbar limited discectomy (as described by Spengler), to limited discectomy alone, with regard to preventing reherniation and the recurrence of pain or dysfunction. Patients, ages 21 - 75, will have, in part, a positive straight leg raise (or positive femoral stretch, as appropriate), MRI confirmation of a disc herniation, and minimum Oswestry and VAS leg scores of 40 out of 100 to qualify for this study. Additional patient criteria can be found in the inclusion/exclusion criteria section.

Superiority of the Barricaid relative to limited discectomy alone will be based on a comparison of overall success rates of the Barricaid and a concurrent group (randomized) of control patients treated by primary lumbar limited discectomy at select European (approximately 15-20) sites.

This study has two co-primary endpoints. Success of the study will be based on the Barricaid population achieving statistical superiority over the concurrently randomized non-implanted limited discectomy population at 2 years.

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.

Primary outcomes:
measure: Patient function as measured on Oswestry Disability Index (ODI)
timeFrame: 24 months
measure: Disc height maintenance as measured from standing x-rays
timeFrame: 24 months
measure: Clinically symptomatic recurrent herniation at the index level, confirmed by imaging
timeFrame: 24 months
measure: Migration of the bone anchor posteriorly into the epidural space
timeFrame: 24 months
measure: Removal or revision of the implant
timeFrame: 24 months
measure: Supplemental fixation applied at the treated level
timeFrame: 24 months
Secondary outcomes:
measure: Back Pain on Visual Analog Scale (VAS)
timeFrame: 24 months
measure: Leg Pain on Visual Analog Scale (VAS)
timeFrame: 24 months
measure: Quality of life on SF36
timeFrame: 24 months
measure: Comparison of neurological symptoms on clinical examination, relative to baseline
timeFrame: 24 months
measure: Frequency of AE's
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Innsbruck, Department of Neurosurgery
name: Claudius Thome, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.