- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01019057
An Evaluation of Interlaminar Lumbar Instrumented (ILIF™) (ILIF)
July 14, 2014 updated by: NuVasive
A Prospective, Non-randomized, Multi-Center Evaluation of Interlaminar Lumbar Instrumented (ILIF™)
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.
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
77
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85020
- Desert Institute for Spine Care, Surgical Specialty Hospital of Arizona
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California
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Santa Monica, California, United States, 90404
- The Spine Institute, St. John's Health Center
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Florida
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Gainesville, Florida, United States, 32605
- North Florida Regional Medical Center
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New Mexico
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Albuquerque, New Mexico, United States, 87102
- Lovelace Medical Center
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South Carolina
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Conway, South Carolina, United States, 29526
- Coastal Orthopaedic Associates PA
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Florence, South Carolina, United States, 29506
- McLeod Regional Medical Center
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Texas
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Fort Worth, Texas, United States, 76102
- Center for Neurological Disorders, Texas Health Harris Methodist Fort Worth
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Virginia
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Norfolk, Virginia, United States, 23510
- Neurosurgical Specialists, DePaul Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Study populuation will be comprised of 50 patients across different cities in the United States.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The change in Oswestry Disability Index scores at 24 months compared to baseline.
Time Frame: preoperative to 24 months follow-up
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preoperative to 24 months follow-up
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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pre-op to 24 months follow-up
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The change in Zurich Claudication Questionnaire scores at 24 months compared to baseline
Time Frame: pre-op to 24 months follow-up
|
pre-op to 24 months follow-up
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The rate of surgical and/or postoperative complications attributable to ILIF™ requiring secondary surgical intervention
Time Frame: pre-op to 24 months follow-up
|
pre-op to 24 months follow-up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hyun Bae, M.D, The Spine Institute in Los Angeles, CA
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
November 23, 2009
First Submitted That Met QC Criteria
November 24, 2009
First Posted (Estimate)
November 25, 2009
Study Record Updates
Last Update Posted (Estimate)
July 15, 2014
Last Update Submitted That Met QC Criteria
July 14, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NUVA.IL.0901
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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