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A Prospective, Non-randomized, Multi-Center Evaluation of Interlaminar Lumbar Instrumented (ILIF?)

This study is currently Recruiting

June 2011 By NuVasive

First Recieved on November 23, 2009

Last Updated on June 10, 2011

Sponsor: NuVasive
Collaborators:
Information provided by: NuVasive
Identifier: NCT01019057

Purpose

Patients diagnosed with single-level degenerative disc disease (DDD) of the lumbar spine undergo a posterior decompression followed by a fusion complete with a spinous process plate, graft, and a biologic.

Study Type: Interventional
Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:40 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: - Patient is over 40 years of age; - Patient is diagnosed with single-level lumbar degenerative disc disease between L1-L2 and L4-L5 with evidence of disc collapse and symptomatic claudication with or without back pain and requires surgical intervention; - Patient is unresponsive to conservative treatment greater than or equal to six month 6 months, or exhibits progressive neurological symptoms in the face of conservative treatment; - Patient is willing and able to comply with the requirements defined in the protocol for the duration of the study; - Patient has signed and dated Informed Consent. Exclusion Criteria: - Patients with lumbar pathologies requiring surgical treatment at more than one level; - Patients with spondylolisthesis > grade 1; - Patients with lytic spondylolisthesis or a defect of the pars interarticularis; - Patients with prior lumbar surgery at or adjacent to the operative level; - Patients with spinal metastases or active spinal tumor malignancy; - Progressive neuromuscular disease, e.g., muscular dystrophy, multiple sclerosis; - Present chronic steroid use; - Patients with rheumatoid arthritis or other autoimmune disease; - Patients who are pregnant or interested in becoming pregnant within the follow-up period of the study; - Patients with a history of substance abuse; - Patients involved in active spinal litigation; - Patients receiving workman's compensation for spinal conditions; - Patients who are mentally incompetent; - Patients who are incarcerated; - Patients who are unwilling or unable to comply with the follow-up protocol schedule of visits and assessments.

Investigators

  • Investigator: Hyun Bae, M.D - Principal Investigator - The Spine Institute in Los Angeles, CA

Locations

  • Desert Institute for Spine Care, Surgical Specialty Hospital of Arizona

    Phoenix, Arizona 85020 United States

  • The Spine Institute, St. John's Health Center

    Santa Monica, California 90404 United States

  • George Washington University

    Washington, District of Columbia 20037 United States

  • North Florida Regional Medical Center

    Gainesville, Florida 32605 United States

  • Macomb Orthopedic Surgeons

    Warren, Michigan 48093 United States

  • Lovelace Medical Center

    Albuquerque, New Mexico 87102 United States

  • Coastal Orthopaedic Associates PA

    Conway, South Carolina 29526 United States

  • McLeod Regional Medical Center

    Florence, South Carolina 29506 United States

  • Center for Neurological Disorders, Texas Health Harris Methodist Fort Worth

    Fort Worth, Texas 76102 United States

  • Neurosurgical Specialists, DePaul Medical Center

    Norfolk, Virginia 23510 United States

Conditions related to this trial:

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