MID-MIS Trial Protocol Comparing Clinical Outcomes, Complications, and Costs of Mini-TLIF and MIDLIF for Discogenic Low Back Pain

What this Trial Is About

Degenerative disc disease (DDD) is a major cause of lower back pain and disability, with its occurrence increasing as people age. This trial is designed to compare two minimally invasive surgical methods, minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) and midline lumbar interbody fusion (MIDLIF), in treating patients with discogenic low back pain unresponsive to conservative treatments. The study aims to provide clearer evidence on which technique may offer better outcomes, fewer complications, and cost advantages. Participants will be randomly assigned to receive either MIS-TLIF or MIDLIF surgery. MIS-TLIF involves a percutaneous approach for screw placement and a lateral approach for decompression, while MIDLIF uses a medial approach with muscle retraction and medialized screw placement. Each participant will be followed for 12 months post-surgery, with evaluations at multiple time points to assess pain, disability, quality of life, complications, and treatment costs. During the study, participants will undergo assessments including pain scales (VAS and NRS), disability questionnaires (COMI, ODI), and quality of life measures (EQ-5D-5L) before surgery and at 1, 3, 6, and 12 months after surgery. Secondary outcomes like complication rates, hospital stay length, procedure duration, blood loss, and imaging for spinal changes will be monitored. The study will also track recovery time and adjacent segment disease through radiological exams. Data will be analyzed to determine differences between the two surgical methods over the year-long follow-up.

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