Study of Lumbar Discectomy with Additional Implantation of an Annular Closure Device in Patients with Large Postsurgical Annular Defects

Overview

About this study

The purpose of this study is to confirm the efficacy of the Barricaid® when used as an adjunct to a primary lumbar limited discectomy, to limited discectomy alone, with regard to preventing reherniation and the recurrence of pain or dysfunction in a US population.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

lusion Criteria:

  • Age 18 to 75 years old and skeletally mature (male or female).
  • Subjects with posterior or posterolateral disc herniations at one level between L4 and S1 with radiographic confirmation of neural compression using MRI. [Note: Intraoperatively, only patients with an anular defect (post discectomy) between 4mm and 6mm tall and 6mm and 10mm wide shall qualify.].
  • 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.
  • Minimum posterior disc height of 5mm at the index level.
  • Radiculopathy (with or without back pain) with a positive Straight Leg Raise (0 - 60 degrees).
  • Oswestry Questionnaire score of at least 40/100 at baseline.
  • VAS leg pain (one or both legs) 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 (25% slip or greater).
  • Subject requires spinal surgery other than a discectomy (with or without laminotomy) to treat leg/back pain (scar tissue and osteophyte removal is allowed).
  • Subject has back or non-radicular leg pain of unknown etiology.
  • Prior surgery at the index lumbar vertebral 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 in the lumbosacral region 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 bone disease.
  • 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 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.)
  • Subject has significant peripheral neuropathy, defined as a subject 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.
  • Any subject that cannot have a baseline MRI taken.
  • Subject is pregnant or interested in becoming pregnant in the next 2 years.
  • Subject has active tuberculosis or has had tuberculosis in the past three (3) years. 
  • Additional Exclusion Criteria may apply.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Selby Chen, M.D.

Contact us for the latest status

Contact information:

Christine Perez Rosa

PerezRosa.Christine@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20485017

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