Clinical trial NCT01019057: An Evaluation of Interlaminar Lumbar Instrumented (ILIF™)
Official title: A Prospective, Non-randomized, Multi-Center Evaluation of Interlaminar Lumbar Instrumented (ILIF™)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Disc Disease
Keywords: DDD
decompression
spinous process plate
Lead sponsor: NuVasive
Sponsor class: INDUSTRY
First posted: 2009-11-25
Enrollment: 77
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study populuation will be comprised of 50 patients across different cities in the United States.

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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: The change in Oswestry Disability Index scores at 24 months compared to baseline.
timeFrame: preoperative to 24 months follow-up
Secondary outcomes:
measure: The change in subject self-reported pain ratings (VAS scores) at 24 months compared to baseline
timeFrame: pre-op to 24 months follow-up
measure: The change in Zurich Claudication Questionnaire scores at 24 months compared to baseline
timeFrame: pre-op to 24 months follow-up
measure: The rate of surgical and/or postoperative complications attributable to ILIF™ requiring secondary surgical intervention
timeFrame: pre-op to 24 months follow-up
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Desert Institute for Spine Care, Surgical Specialty Hospital of Arizona
state: Arizona
city: Santa Monica
country: United States
facility: The Spine Institute, St. John's Health Center
state: California
city: Gainesville
country: United States
facility: North Florida Regional Medical Center
state: Florida
city: Albuquerque
country: United States
facility: Lovelace Medical Center
state: New Mexico
city: Conway
country: United States
facility: Coastal Orthopaedic Associates PA
state: South Carolina
city: Florence
country: United States
facility: McLeod Regional Medical Center
state: South Carolina
city: Fort Worth
country: United States
facility: Center for Neurological Disorders, Texas Health Harris Methodist Fort Worth
state: Texas
city: Norfolk
country: United States
facility: Neurosurgical Specialists, DePaul Medical Center
state: Virginia
Study officials:
affiliation: The Spine Institute in Los Angeles, CA
name: Hyun Bae, M.D
role: PRINCIPAL_INVESTIGATOR
References: