An Evaluation of Interlaminar Lumbar Instrumented (ILIF™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NuVasive
ClinicalTrials.gov Identifier:
NCT01019057
First received: November 23, 2009
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Degenerative Disc Disease
Procedure: ILIF

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Non-randomized, Multi-Center Evaluation of Interlaminar Lumbar Instrumented (ILIF™)

Further study details as provided by NuVasive:

Primary Outcome Measures:
  • The change in Oswestry Disability Index scores at 24 months compared to baseline. [ Time Frame: preoperative to 24 months follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change in subject self-reported pain ratings (VAS scores) at 24 months compared to baseline [ Time Frame: pre-op to 24 months follow-up ] [ Designated as safety issue: No ]
  • The change in Zurich Claudication Questionnaire scores at 24 months compared to baseline [ Time Frame: pre-op to 24 months follow-up ] [ Designated as safety issue: No ]
  • The rate of surgical and/or postoperative complications attributable to ILIF™ requiring secondary surgical intervention [ Time Frame: pre-op to 24 months follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 77
Study Start Date: November 2009
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01019057

Locations
United States, Arizona
Desert Institute for Spine Care, Surgical Specialty Hospital of Arizona
Phoenix, Arizona, United States, 85020
United States, California
The Spine Institute, St. John's Health Center
Santa Monica, California, United States, 90404
United States, Florida
North Florida Regional Medical Center
Gainesville, Florida, United States, 32605
United States, New Mexico
Lovelace Medical Center
Albuquerque, New Mexico, United States, 87102
United States, South Carolina
Coastal Orthopaedic Associates PA
Conway, South Carolina, United States, 29526
McLeod Regional Medical Center
Florence, South Carolina, United States, 29506
United States, Texas
Center for Neurological Disorders, Texas Health Harris Methodist Fort Worth
Fort Worth, Texas, United States, 76102
United States, Virginia
Neurosurgical Specialists, DePaul Medical Center
Norfolk, Virginia, United States, 23510
Sponsors and Collaborators
NuVasive
Investigators
Principal Investigator: Hyun Bae, M.D The Spine Institute in Los Angeles, CA
  More Information

Additional Information:
No publications provided

Responsible Party: NuVasive
ClinicalTrials.gov Identifier: NCT01019057     History of Changes
Other Study ID Numbers: NUVA.IL.0901
Study First Received: November 23, 2009
Last Updated: July 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by NuVasive:
DDD
decompression
spinous process plate

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 18, 2014