An Evaluation of Interlaminar Lumbar Instrumented (ILIF™)

Degenerative Disc Disease Clinical Trial

— ILIF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01019057
• Other study ID #: NUVA.IL.0901
• Status: Completed
• Phase: N/A
• First received: November 23, 2009
• Last updated: July 14, 2014
• Start date: November 2009
• Est. completion date: June 2014

Study information

• Verified date: July 2014
• Source: NuVasive
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

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. Because this compound solution requires only a midline incision rather than the far lateral exposure necessary in posterolateral fusion with pedicle screws, it is less invasive to the patient, and therefore should result in less postoperative pain and disability, broadening the applicability of the procedure to even those advanced in age or with existing comorbidities. Subjects will be followed for 24 months following surgery to determine the changes in ODI scores from preoperative to baseline assessments. This data will be compared to published data on similar procedures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
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	North Florida Regional Medical Center	Gainesville	Florida
United States	Neurosurgical Specialists, DePaul Medical Center	Norfolk	Virginia
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
NuVasive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in Oswestry Disability Index scores at 24 months compared to baseline.		preoperative to 24 months follow-up	No
Secondary	The change in subject self-reported pain ratings (VAS scores) at 24 months compared to baseline		pre-op to 24 months follow-up	No
Secondary	The change in Zurich Claudication Questionnaire scores at 24 months compared to baseline		pre-op to 24 months follow-up	No
Secondary	The rate of surgical and/or postoperative complications attributable to ILIF™ requiring secondary surgical intervention		pre-op to 24 months follow-up	Yes

External Links

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