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

Official title

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

Overview

Background Degenerative disc disease (DDD) is the leading cause of lower back pain and disability, which prevalence increasing with age. When conservative treatment fails, surgical methods of spinal fusion are employed. Minimally invasive techniques, including minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) and midline lumbar interbody fusion (MIDLIF), have well-documented advantages over traditional open transforaminal interbody fusion (open-TLIF). However, data comparing these two minimally invasive methods in treating DDD are minimal and sometimes contradictory. I am running a few minutes late; my previous meeting is running over. Methods This is a prospective, randomized, partially blinded, two-arm trial aiming to compare the outcomes, complications, and treatment costs of MIS-TLIF and MIDLIF in patients with discogenic low back pain. A total of 100 adult patients with lumbosacral spine pain and radicular symptoms, unresponsive to conservative treatment for over one year, will be enrolled. Patients will be randomized (1:1) into two arms: MIS-TLIF (control, n=50) and MIDLIF (intervention, n=50), with a 12-month follow-up. Inclusion criteria include age ≥18 years and discopathy at one or two levels requiring interbody stabilization. Exclusion criteria include multilevel pathology, spinal deformities, and pain causes other than degenerative disease. Primary endpoints assess pain (VAS, NRS scales), disability (COMI, ODI questionnaires), and quality of life (EQ-5D-5L questionnaire) at 1, 3, 6, and 12 months post-surgery. Secondary endpoints include complication rates (nerve root damage, infections), costs (hospitalization, implants), length of hospital stay, procedure duration, blood loss, morphometric parameters (intervertebral space height), and adjacent segment disease based on imaging studies (MRI, CT, X-ray). Data analysis uses parametric/non-parametric tests (e.g., t-test, Mann-Whitney) in the R software. The trial adheres to the Helsinki Declaration, with ethics approval (no. 112/2024). Discussion Data on the comparison of MIDLIF and MIS-TLIF in treating DDD are minimal and inconsistent. Some reports have advantaged MIDLIF in shorter operative time, decreased intraoperative blood loss, and reduced hospital stays, while others favor MIS-TLIF. This trial addresses these gaps by providing high-quality evidence on clinical superiority, cost-effectiveness, and long-term outcomes compering MIDLIF and MIS-TLIF. There is a high need for a high-quality, prospective study to examine this problem.

Interventions

• Procedure Midline Lumbar Interbody Fusion (MIDLIF)
  Midline Lumbar Interbody Fusion (MIDLIF) is a procedure utilizes a medial approach to the spine, involving the retraction of the segmental back muscles to expose the lamine and articular processes. Screw placement is medialized, with entry to a point along the pars intercularis or joint surface. It places the screw through potentially more cortical and stronger bone. Decompression is achieved by resecting the inferior articular process and lamina marginalis, followed by a discectomy. Subsequentl
• Procedure Minimally Invasive Transforaminal Lumbar Interbody Fusion (mini-TLIF)
  Minimally invasive Transforaminal Lumbar Interbody Fusion (mini-TLIF) is a procedure that employs a percutaneous approach for pedicle screw placement through the pedicles. Decompression is performed using a lateral approach, with 2-3 cm lateral to the ipsilateral borders. This is followed by resection of the inferior articular process and removal of the ligamentum flavum, facilitating discectomy. An interbody cage is then inserted to achieve fusion.

Primary outcome measures

• Visual Analog Scale (VAS) [Time frame: 1 day before randomization, up to 24 hours after randomization, 2 days after randomization, 1 month after randomization, 3 months after randomization, 6 months after randomization, 12 months after randomization]
• Numeric Rating Scale (NRS) [Time frame: 1 day before randomization, up to 24 hours after randomization, 2 days after randomization, 1 month after randomization, 3 months after randomization, 6 months after randomization, 12 months after randomization]
• Core Outcome Measures Index [Time frame: 1 day before randomization, up to 24 hours after randomization, 2 days after randomization, 1 month after randomization, 3 months after randomization, 6 months after randomization, 12 months after randomization]
• Oswestry Disability Index (ODI) [Time frame: 1 day before randomization, up to 24 hours after randomization, 2 days after randomization, 1 month after randomization, 3 months after randomization, 6 months after randomization, 12 months after randomization]
• European Quality of Life - 5 Dimensions, 5 Levels [Time frame: 1 day before randomization, up to 24 hours after randomization, 2 days after randomization, 1 month after randomization, 3 months after randomization, 6 months after randomization, 12 months after randomization]

Secondary outcome measures (8)

• Complication Rates and Types [Time frame: Up to 24 hours after randomization, 2 days after randomization, 1 month after randomization, 3 months after randomization, 6 months after randomization, 12 months after randomization]
• Direct Treatment Costs [Time frame: 12 months after randomization]
• Hospitalization Duration [Time frame: 2 days after randomization (day of hospital discharge)]
• Procedure Duration [Time frame: 2 days after randomization]
• Blood Loss [Time frame: 2 days after randomization]
• Spinal Morphometric Parameters [Time frame: 2 days after randomization, 3 months after randomization, 12 months after randomization]
• Time to Return to Professional Activity [Time frame: 12 months after randomization]
• Radiological Assessment of Adjacent Segment Disease [Time frame: 12 months after randomization]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Poland · 1 center

• Copernicus Memorial Hospital in Łódź, Poland — Lodz

Publications

• Silva PS, Jardim A, Pereira J, Sousa R, Vaz R, Pereira P. Minimally invasive fusion surgery for patients with degenerative spondylolisthesis and severe lumbar spinal stenosis: a comparative study between MIDLIF and TLIF. Eur Spine J. 2023 Sep;32(9):3210-3217. doi: 10.1007/s00586-023-07847-6. Epub 2023 Jul 9. PMID 37422769
• Tippins NP, Foreit AM, Kussow NJ, Milne CM, Narayanan AM, Neely MR, Poplarski JH, Reasoner JT, Ricks K, Alentado VJ, Potts EA, Mobasser JP. Examination of clinical and radiographic outcomes after lumbar interbody fusion: a retrospective analysis of TLIF, MidLIF, and MIS-TLIF procedures. J Neurosurg Spine. 2025 May 2;43(1):52-62. doi: 10.3171/2025.1.SPINE241286. Print 2025 Jul 1. PMID 40315609
• Crawford CH 3rd, Owens RK 2nd, Djurasovic M, Gum JL, Dimar JR 2nd, Carreon LY. Minimally-Invasive midline posterior interbody fusion with cortical bone trajectory screws compares favorably to traditional open transforaminal interbody fusion. Heliyon. 2019 Sep 11;5(9):e02423. doi: 10.1016/j.heliyon.2019.e02423. eCollection 2019 Sep. PMID 31535047
• Parker SL, Adogwa O, Witham TF, Aaronson OS, Cheng J, McGirt MJ. Post-operative infection after minimally invasive versus open transforaminal lumbar interbody fusion (TLIF): literature review and cost analysis. Minim Invasive Neurosurg. 2011 Feb;54(1):33-7. doi: 10.1055/s-0030-1269904. Epub 2011 Apr 19. PMID 21506066
• Xie L, Wu WJ, Liang Y. Comparison between Minimally Invasive Transforaminal Lumbar Interbody Fusion and Conventional Open Transforaminal Lumbar Interbody Fusion: An Updated Meta-analysis. Chin Med J (Engl). 2016 Aug 20;129(16):1969-86. doi: 10.4103/0366-6999.187847. PMID 27503024
• Xue J, Song Y, Liu H, Liu L, Li T, Gong Q. Minimally invasive versus open transforaminal lumbar interbody fusion for single segmental lumbar disc herniation: A meta-analysis. J Back Musculoskelet Rehabil. 2022;35(3):505-516. doi: 10.3233/BMR-210004. PMID 34602458
• Heemskerk JL, Oluwadara Akinduro O, Clifton W, Quinones-Hinojosa A, Abode-Iyamah KO. Long-term clinical outcome of minimally invasive versus open single-level transforaminal lumbar interbody fusion for degenerative lumbar diseases: a meta-analysis. Spine J. 2021 Dec;21(12):2049-2065. doi: 10.1016/j.spinee.2021.07.006. Epub 2021 Jul 14. PMID 34273567
• Phani Kiran S, Sudhir G. Minimally invasive transforaminal lumbar interbody fusion - A narrative review on the present status. J Clin Orthop Trauma. 2021 Sep 8;22:101592. doi: 10.1016/j.jcot.2021.101592. eCollection 2021 Nov. PMID 34603954

Identifiers

NCT: NCT07127380 · 112/2024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗