Comparing mini‑TLIF versus MIDLIF for disc-related low back pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, partially blinded, two-arm trial enrolling 100 adults with lumbosacral discogenic pain unresponsive to conservative care to compare mini‑TLIF and midline lumbar interbody fusion (MIDLIF). Participants are randomized to receive one of the two minimally invasive fusion procedures and are followed for clinical outcomes, complication rates, and treatment costs. Outcomes include pain and functional measures, perioperative complications, and an economic analysis of treatment-related costs. The trial is conducted at Copernicus Memorial Hospital in Łódź, Poland.

Why it matters

Who can join: the full rules

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

Where it's running

• Copernicus Memorial Hospital in Łódź, Poland
  Lodz, Łódź Voivodeship, Poland Recruiting

Study contacts

• Study coordinator: Aleksander Kowal, MD
• Email: aleksanderwkowal@gmail.com
• Phone: +48426895341

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.