An Evaluation of Interlaminar Lumbar Instrumented (ILIF™)
NCT ID: NCT01019057
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
77 participants
OBSERVATIONAL
2009-11-30
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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ILIF
Interlaminar lumbar instrumented fusion (ILIF™) is a compound surgical solution to spinal stenosis, combining direct neural decompression with an allograft interspinous spacer (ExtenSure® H2) to maintain the segmental distraction, and a spinous process fixation plate (Affix™) to maintain stability for eventual segmental fusion.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
40 Years
ALL
No
Sponsors
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NuVasive
INDUSTRY
Responsible Party
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Principal Investigators
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Hyun Bae, M.D
Role: PRINCIPAL_INVESTIGATOR
The Spine Institute in Los Angeles, CA
Locations
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Desert Institute for Spine Care, Surgical Specialty Hospital of Arizona
Phoenix, Arizona, United States
The Spine Institute, St. John's Health Center
Santa Monica, California, United States
North Florida Regional Medical Center
Gainesville, Florida, United States
Lovelace Medical Center
Albuquerque, New Mexico, United States
Coastal Orthopaedic Associates PA
Conway, South Carolina, United States
McLeod Regional Medical Center
Florence, South Carolina, United States
Center for Neurological Disorders, Texas Health Harris Methodist Fort Worth
Fort Worth, Texas, United States
Neurosurgical Specialists, DePaul Medical Center
Norfolk, Virginia, United States
Countries
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Related Links
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Related Info
Other Identifiers
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NUVA.IL.0901
Identifier Type: -
Identifier Source: org_study_id