Post-operative infection after minimally invasive versus open transforaminal lumbar interbody fusion (TLIF): literature review and cost analysis.
S L Parker, O Adogwa, T F Witham...
https://pubmed.ncbi.nlm.nih.gov/21506066/Actively Recruiting
Led by Copernicus Memorial Hospital · Updated on 2026-04-15
100
Participants Needed
1
Research Sites
1 weeks
Total Duration
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.
CONDITIONS
Comparison of Clinical Outcomes, Complications Rate and Treatment Costs of Mini-TLIF and MIDLIF in the Treatment of Discogenic Low Back Pain
A
Aleksander Kowal, MD
K
Kamil Krystkiewicz, MD, PhD
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Copernicus Memorial Hospital
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 days
Participants undergo either Mini-TLIF or MIDLIF surgery to treat discogenic low back pain, followed by immediate post-operative care.
Hospitalization with approximately 2 days until discharge
Duration - Up to 12 months
Participants are monitored through follow-up visits to assess recovery, complications, and treatment outcomes including pain, disability, and quality of life.
Multiple visits at 2 days, 1 month, 3 months, 6 months, and 12 months after surgery
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor