An Evaluation of Interlaminar Lumbar Instrumented (ILIF™) (NCT01019057) | Clinical Trial Compass
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 range40 Years
SexALL
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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…
What they're measuring
1
The change in Oswestry Disability Index scores at 24 months compared to baseline.