MIS-TLIF versus O-TLIF for single-level degenerative stenosis: study protocol for randomised controlled trial

Area of Science:

• Spine surgery
• Orthopedics
• Minimally invasive procedures

Background:

• Degenerative stenosis and low-grade spondylolisthesis often require nerve root decompression and spinal fusion.
• Traditional open decompression and fusion (O-TLIF) is the standard, but minimally invasive techniques are gaining prevalence.
• High-quality comparative studies are needed to establish the advantages and indications for each method.

Purpose of the Study:

• To compare the effectiveness of minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) against traditional open transforaminal lumbar interbody fusion (O-TLIF).
• To evaluate clinical, safety, and radiological outcomes for both surgical techniques.
• To identify specific indications for each surgical approach in treating symptomatic single-level degenerative stenosis with low-grade spondylolisthesis.

Main Methods:

• Randomized controlled trial comparing MIS-TLIF and O-TLIF in patients aged 40-75 with specific spinal conditions.
• Primary outcome: Oswestry Disability Index at 3 months.
• Secondary outcomes include patient-reported measures, radiological parameters (e.g., sagittal balance), safety endpoints, and cost-effectiveness, with follow-up to 24 months.

Main Results:

• The study is designed to demonstrate non-inferior clinical results for MIS-TLIF compared to O-TLIF.
• Analysis will include preoperative and multiple postoperative follow-up points (14 days, 3, 6, 12, and 24 months).
• Data collection focuses on clinical improvement, safety, and radiological changes.

Conclusions:

• This research will provide crucial data on the comparative efficacy of MIS-TLIF versus O-TLIF.
• Findings will help guide surgical decision-making for degenerative spinal conditions.
• The study aims to establish evidence-based indications for minimally invasive spinal fusion techniques.