Degenerative Disc DiseaseILIFNCT01019057
An Evaluation of Interlaminar Lumbar Instrumented (ILIF™)
An observational study of Degenerative Disc Disease, run by NuVasive at 8 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- ILIF
- Type of treatment
- Surgery or procedure
- How many people
- 77 participants
- Where
- 8 sitesUnited States
- Study dates
- Nov 2009to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study populuation will be comprised of 50 patients across different cities in the United States.
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Lovelace Medical Center
Albuquerque, New Mexico, 87102
Coastal Orthopaedic Associates PA
Conway, South Carolina, 29526
McLeod Regional Medical Center
Florence, South Carolina, 29506
Center for Neurological Disorders, Texas Health Harris Methodist Fort Worth
Fort Worth, Texas, 76102
North Florida Regional Medical Center
Gainesville, Florida, 32605
Neurosurgical Specialists, DePaul Medical Center
Norfolk, Virginia, 23510
Desert Institute for Spine Care, Surgical Specialty Hospital of Arizona
Phoenix, Arizona, 85020
The Spine Institute, St. John's Health Center
Santa Monica, California, 90404
About this study
Official title: 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.
Read the 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.
- Conditions
- Degenerative Disc Disease
- Being tested
- ILIF
- Keywords
- DDD, decompression, spinous process plate
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ILIFProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in Oswestry Disability Index scores at 24 months compared to baseline.
Measured: 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
Measured: pre-op to 24 months follow-up
The change in Zurich Claudication Questionnaire scores at 24 months compared to baseline
Measured: pre-op to 24 months follow-up
The rate of surgical and/or postoperative complications attributable to ILIF™ requiring secondary surgical intervention
Measured: pre-op to 24 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuVasive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyun Bae, M.D, Principal investigator, The Spine Institute in Los Angeles, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019057
- Sponsor's protocol ID
- NUVA.IL.0901
- Acronym
- ILIF
- Status last verified
- Dec 2025
- First submitted
- 23 Nov 2009
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-randomized, Multi-Center Evaluation of Interlaminar Lumbar Instrumented (ILIF™)
- ClinicalTrials.gov ID
- NCT01019057
- Acronym / sponsor ID
- ILIF / NUVA.IL.0901
- Conditions
- Degenerative Disc Disease
- Keywords
- DDD, decompression, spinous process plate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- NuVasiveIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 25 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study populuation will be comprised of 50 patients across different cities in the United States.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ILIFInterlaminar 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. | Procedure or surgery | – |
Primary outcome
The change in Oswestry Disability Index scores at 24 months compared to baseline.
Time frame: preoperative to 24 months follow-up
3 secondary outcomes
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
The change in Zurich Claudication Questionnaire scores at 24 months compared to baseline
Time frame: pre-op to 24 months follow-up
The rate of surgical and/or postoperative complications attributable to ILIF™ requiring secondary surgical intervention
Time frame: pre-op to 24 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyun Bae, M.D principal investigator
The Spine Institute in Los Angeles, CA
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease, run by NuVasive at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in Oswestry Disability Index scores at 24 months compared to baseline. (time frame: preoperative to 24 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.