Comparison of Clinical Outcomes, Complications Rate and Treatment Costs of Mini-TLIF and MIDLIF in the Treatment of Discogenic Low Back Pain
NCT ID: NCT07127380
Last Updated: 2025-08-27
Study Results
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Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-01-19
2027-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Minimally Invasive Transforaminal Lumbar Interbody Fusion (mini-TLIF)
Lumbar fusion is obatained by Minimally Invasive Transforaminal Lumbar Interbody Fusion
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.
Midline Lumbar Interbody Fusion (MIDLIF)
Lumbar fusion is obtained by Midline Lumbar Interbody Fusion
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. Subsequently, a transforaminal lumbar interbody fusion (TLIF) is performed to place an interbody cage and promote fusion.
Interventions
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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. Subsequently, a transforaminal lumbar interbody fusion (TLIF) is performed to place an interbody cage and promote fusion.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Copernicus Memorial Hospital
OTHER
Responsible Party
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Kamil Krystkiewicz
MD, PhD, neurosurgeon
Locations
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Copernicus Memorial Hospital in Łódź, Poland
Lodz, Łódź Voivodeship, Poland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Zhang X, Zhang Y, Gu Z, Li G. Comparison of midline lumbar interbody fusion and minimally invasive transforaminal lumbar interbody fusion for treatment of lumbar degeneration disease. Sci Rep. 2024 Sep 27;14(1):22154. doi: 10.1038/s41598-024-73213-1.
Wang YY, Chung YH, Huang CH, Hu MH. Comparison of minimally invasive transforaminal lumbar interbody fusion and midline lumbar interbody fusion in patients with spondylolisthesis. J Orthop Surg Res. 2024 May 9;19(1):286. doi: 10.1186/s13018-024-04764-2.
Silva F, Silva PS, Vaz R, Pereira P. Midline lumbar interbody fusion (MIDLIF) with cortical screws: initial experience and learning curve. Acta Neurochir (Wien). 2019 Dec;161(12):2415-2420. doi: 10.1007/s00701-019-04079-w. Epub 2019 Oct 24.
Dave BR, Marathe N, Mayi S, Degulmadi D, Rai RR, Patil S, Jadav K, Bali SK, Kumar A, Meena U, Parmar V, Amin P, Dave M, Krishnan PA, Krishnan A. Does Conventional Open TLIF cause more Muscle Injury when Compared to Minimally Invasive TLIF?-A Prospective Single Center Analysis. Global Spine J. 2024 Jan;14(1):93-100. doi: 10.1177/21925682221095467. Epub 2022 Apr 20.
Modi HN, Shrestha U. Comparison of Clinical Outcome and Radiologic Parameters in Open TLIF Versus MIS-TLIF in Single- or Double-Level Lumbar Surgeries. Int J Spine Surg. 2021 Oct;15(5):962-970. doi: 10.14444/8126. Epub 2021 Sep 22.
Tan JH, Liu G, Ng R, Kumar N, Wong HK, Liu G. Is MIS-TLIF superior to open TLIF in obese patients?: A systematic review and meta-analysis. Eur Spine J. 2018 Aug;27(8):1877-1886. doi: 10.1007/s00586-018-5630-0. Epub 2018 Jun 1.
Mobbs RJ, Phan K, Malham G, Seex K, Rao PJ. Lumbar interbody fusion: techniques, indications and comparison of interbody fusion options including PLIF, TLIF, MI-TLIF, OLIF/ATP, LLIF and ALIF. J Spine Surg. 2015 Dec;1(1):2-18. doi: 10.3978/j.issn.2414-469X.2015.10.05.
Mohd Isa IL, Teoh SL, Mohd Nor NH, Mokhtar SA. Discogenic Low Back Pain: Anatomy, Pathophysiology and Treatments of Intervertebral Disc Degeneration. Int J Mol Sci. 2022 Dec 22;24(1):208. doi: 10.3390/ijms24010208.
Wu PH, Kim HS, Jang IT. Intervertebral Disc Diseases PART 2: A Review of the Current Diagnostic and Treatment Strategies for Intervertebral Disc Disease. Int J Mol Sci. 2020 Mar 20;21(6):2135. doi: 10.3390/ijms21062135.
Chou R. Low Back Pain. Ann Intern Med. 2021 Aug;174(8):ITC113-ITC128. doi: 10.7326/AITC202108170. Epub 2021 Aug 10.
Other Identifiers
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112/2024
Identifier Type: -
Identifier Source: org_study_id
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