Comparing mini‑TLIF versus MIDLIF for disc-related low back pain
MID-MIS Trail Protocol - Comparison of Clinical Outcomes, Complications Rate and Treatment Costs of Mini-TLIF and MIDLIF in the Treatment of Discogenic Low Back Pain
This trial tests whether mini‑TLIF or MIDLIF gives better pain relief, fewer complications, and lower costs for adults with discogenic lower back pain who haven't improved with non-surgical treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Copernicus Memorial Hospital Academic / other |
| Locations | 1 site (Lodz, Łódź Voivodeship) |
| Trial ID | NCT07127380 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with chronic discogenic lumbosacral pain lasting more than one year who have failed conservative therapy, have lumbar disc disease suitable for interbody fusion at one or two levels, and can give informed consent are ideal candidates.
Not a fit: Patients with non-degenerative causes of back pain, spinal deformities, multi-level disease requiring fusion at more than two levels, pregnancy, or contraindications to general anesthesia are unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, the results could identify which procedure provides better pain relief, fewer complications, and lower overall costs for patients with degenerative disc disease.
How similar studies have performed: Minimally invasive TLIF approaches have shown advantages over open techniques in prior studies, but randomized head-to-head comparisons between mini‑TLIF and MIDLIF are limited and have yielded mixed results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Lodz, Łódź Voivodeship
- Copernicus Memorial Hospital in Łódź, Poland — Lodz, Łódź Voivodeship, Poland (Recruiting)
Study contacts
- Study coordinator: Aleksander Kowal, MD
- Email: aleksanderwkowal@gmail.com
- Phone: +48426895341
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.