Condition: Lower Back Pain Chronic · Lumbar Degenerative Disease · Lumbar Disc Degeneration · Sponsor: Copernicus Memorial Hospital
Background Degenerative disc disease (DDD) is the leading cause of lower back pain and disability, which prevalence increasing with age. When conservative treatment fails, surgical methods of spinal fusion are employed. Minimally invasive techniques, including minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) and midline lumbar interbody fusion (MIDLIF), have well-documented advantages over traditional open transforaminal interbody fusion (open-TLIF). However, data comparing these two minimally invasive methods in treating DDD are minimal and sometimes contradictory. I am running a few minutes late; my previous meeting is running over. Methods This is a prospective, randomized, partially blinded, two-arm trial aiming to compare the outcomes, complications, and treatment costs of MIS-TLIF and MIDLIF in patients with discogenic low back pain. A total of 100 adult patients with lumbosacral spine pain and radicular symptoms, unresponsive to conservative treatment for over one year, will be enrolled. Patients will be randomized (1:1) into two arms: MIS-TLIF (control, n=50) and MIDLIF (intervention, n=50), with a 12-month follow-up. Inclusion criteria include age ≥18 years and discopathy at one or two levels requiring interbody stabilization. Exclusion criteria include multilevel pathology, spinal deformities, and pain causes other than degenerative disease. Primary endpoints assess pain (VAS, NRS scales), disability (COMI, ODI questionnaires), and quality of l…
This description comes directly from the study's public registry record.
Aleksander Kowal, MD · +48426895341 · aleksanderwkowal@gmail.com
Kamil Krystkiewicz, MD, PhD · +48426895341 · kamil.krystkiewicz@gmail.com
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| Copernicus Memorial Hospital in Łódź, Poland | Lodz, Łódź Voivodeship, Poland | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07127380