An Evaluation of Interlaminar Lumbar Instrumented (ILIF™)

NCT01019057 | Completed

• 1 other identifier: NUVA.IL.0901
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Degenerative Disc Disease

Keywords

DDD; decompression; spinous process plate

Outcome Measures

Primary Outcomes (1)

• The change in Oswestry Disability Index scores at 24 months compared to baseline.

  preoperative to 24 months follow-up

Secondary Outcomes (3)

• The change in subject self-reported pain ratings (VAS scores) at 24 months compared to baseline

  pre-op to 24 months follow-up

• The change in Zurich Claudication Questionnaire scores at 24 months compared to baseline

  pre-op to 24 months follow-up

• The rate of surgical and/or postoperative complications attributable to ILIF™ requiring secondary surgical intervention

  pre-op to 24 months follow-up

Interventions

ILIF PROCEDURE

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

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study populuation will be comprised of 50 patients across different cities in the United States.

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.

Sponsors & Collaborators

• NuVasive: lead

Study Sites (8)

Desert Institute for Spine Care, Surgical Specialty Hospital of Arizona

Phoenix, Arizona, 85020, United States

Location

The Spine Institute, St. John's Health Center

Santa Monica, California, 90404, United States

Location

North Florida Regional Medical Center

Gainesville, Florida, 32605, United States

Location

Lovelace Medical Center

Albuquerque, New Mexico, 87102, United States

Location

Coastal Orthopaedic Associates PA

Conway, South Carolina, 29526, United States

Location

McLeod Regional Medical Center

Florence, South Carolina, 29506, United States

Location

Center for Neurological Disorders, Texas Health Harris Methodist Fort Worth

Fort Worth, Texas, 76102, United States

Location

Neurosurgical Specialists, DePaul Medical Center

Norfolk, Virginia, 23510, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Hyun Bae, M.D

  The Spine Institute in Los Angeles, CA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2009
• First Posted: November 25, 2009
• Study Start: November 1, 2009
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

US (8)