An Evaluation of Interlaminar Lumbar Instrumented (ILIF™)

Completed

Conditions studied: Degenerative Disc Disease

In brief

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.

Key facts

Study ID

NCT01019057

Run by

NuVasive

People needed

77

Starts

2009-11-01

Expected to finish

2014-06-01

Last updated by the study team

2025-12-24

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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