A Post Marketing Surveillance Study

NCT03366779 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: EUBARD-CP-001-6MM
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Lumbar Disc Herniation; Annular Disc Tear; Annular Tear of Lumbar Disc

Keywords

Lumbar disc herniation, reherniation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Device condition, reoperation at index level and long term performance

  Through 24Month post implantation

• Visual Analog Scale - leg pain

  Through 24Month post implantation

• Visual Analog scale - back pain

  Through 24Month post implantation

• Oswestry Disability Index

  Through 24Month post implantation

Study Arms (1)

Surgery with 6mm ACD

OTHER

ACD medical device (non-experimental). Surgical device implantation after standard lumbar discectomy.

Device: 6mm annular closure device

Interventions

6mm annular closure device DEVICE

6MM Barricaid annular closure device implantation following standard lumbar discectomy

Surgery with 6mm ACD

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Intrinsic Therapeutics: lead

Study Sites (2)

OLVZ Aalst

Aalst, 9300, Belgium

Location

Klinikum Itzehoe

Itzehoe, 25524, Germany

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter non-randomized device trial

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 8, 2017
• Study Start: January 16, 2018
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

BE (1); DE (1)