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Comparison of Clinical Outcomes, Complications Rate and Treatment Costs of Mini-TLIF and MIDLIF in the Treatment of Discogenic Low Back Pain

RecruitingNAAges 18 Years - anyAllCopernicus Memorial Hospital
NCT07127380 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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 patie

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Discogenic lower lumbar-sacral pain lasting longer than one year * Failure of conservative treatment, including rehabilitation and pain management * Lumbar discopathy qualified for interbody fusion and pedicle screw stabilization * Informed consent of the patient for the study and proposed treatment Exclusion Criteria: * Contraindications to surgery under general anesthesia * Age \< 18 years * Pregnancy, breastfeeding * Lack of informed consent to participate in the study * Lumbar-sac discopathy requiring surgical treatment at more than two levels * Spinal deformities: adult idiopathic scoliosis, degenerative scoliosis, deformity due to spinal malignancy, inflammatory spinal disease, post-traumatic, or associated with congenital anomalies * Lower lumbar-sacral pain syndrome, which, in the investigator's opinion, has an etiology other than degenerative spine disease (e.g., cancer-related pain, ankylosing spondylitis) * Spinal oncology disease * True and degenerative spondylolisthesis * Contraindications to performing MRI of the lumbar-sacral spine
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What it tests

  • Midline Lumbar Interbody Fusion (MIDLIF)
  • Minimally Invasive Transforaminal Lumbar Interbody Fusion (mini-TLIF)
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Where

1 site
Copernicus Memorial Hospital in ลรณdลบ, Poland
Lodz, Poland
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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