A Post Marketing Surveillance Study (6MM)

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

This study is a prospective, multi-center study to monitor the early safety and performance of one iteration of the Barricaid Anular Closure Device (ACD) - 6mm anchor width, when used as an adjunct to limited discectomy.

Study Overview

• Status: Active, not recruiting
• Conditions: Lumbar Disc Herniation; Annular Disc Tear; Annular Tear of Lumbar Disc
• Intervention / Treatment: Device: 6mm annular closure device

Detailed Description

This study is planned to collect information on use of the Barricaid ACD with an anchor width of 6mm. Other iterations of the device are made with an 8mm wide anchor. The narrower anchor was designed to optimize surgeon visualization during implantation, and has undergone all appropriate rigorous testing prior to release. Safety will be evaluated to demonstrate acceptable levels of device-related and procedure-related complications. This limited market release will allow its performance to be evaluated by examining the effects on reoperation, device deficiencies, patient pain scores and disability after discectomy with ACD.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • OLVZ Aalst
• Germany
  • Itzehoe, Germany, 25524
    • Klinikum Itzehoe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Surgery with 6mm ACD; ACD medical device (non-experimental). Surgical device implantation after standard lumbar discectomy.	Device: 6mm annular closure device; 6MM Barricaid annular closure device implantation following standard lumbar discectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device stability	To be considered a success the subjects would require to have a lack of implant migration through 3 months after surgery	3 months post implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device condition, reoperation at index level and long term performance	Will be analyzed and compared to available clinical and commercial data on the Barricaid device	Through 24Month post implantation
Visual Analog Scale - leg pain	Change in leg pain as measured using a Visual Analog Scale (VAS), on a scale of 0-100, with lower values representing better outcome.	Through 24Month post implantation
Visual Analog scale - back pain	Change in back pain as measured using a Visual Analog Scale (VAS), on a scale of 0-100, with lower values representing better outcome.	Through 24Month post implantation
Oswestry Disability Index	Change in function as measured using the Oswestry Disability Index (ODI)	Through 24Month post implantation

Collaborators and Investigators

• Sponsor: Intrinsic Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2018
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 28, 2017
• First Submitted That Met QC Criteria: December 6, 2017
• First Posted (Actual): December 8, 2017

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Lumbar disc herniation, reherniation
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: EUBARD-CP-001-6MM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No