CompletedNot Applicable

An Evaluation of Interlaminar Lumbar Instrumented (ILIF™)

United States77 participantsStarted 2009-11

Plain-language 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.

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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; * Pat…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The change in Oswestry Disability Index scores at 24 months compared to baseline.

Timeframe: preoperative to 24 months follow-up

Trial details

NCT IDNCT01019057

SponsorNuVasive

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2014-06

View on ClinicalTrials.gov More Degenerative Disc Disease trials

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.