Lower Back Pain ChronicMID-MISNCT07127380

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

A study testing Midline Lumbar Interbody Fusion (MIDLIF) and Minimally Invasive Transforaminal Lumbar Interbody Fusion (mini-TLIF) in people with Lower Back Pain Chronic and Lumbar Degenerative Disease, run by Copernicus Memorial Hospital at 1 site in Poland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lower Back Pain Chronic, Lumbar Degenerative Disease, Lumbar Disc Degeneration
What is being tested?: Midline Lumbar Interbody Fusion (MIDLIF) and Minimally Invasive Transforaminal Lumbar Interbody Fusion (mini-TLIF)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 sitePoland
Study dates: 19 Jan 2025to 31 Jan 2028
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Aleksander Kowal, MD contact

+48426895341

aleksanderwkowal@gmail.com

Kamil Krystkiewicz, MD, PhD contact

+48426895341

kamil.krystkiewicz@gmail.com

Poland1 site, 1 recruiting

Copernicus Memorial Hospital in Łódź, Poland
Lodz, Łódź Voivodeship, 93-513
Aleksander Kowal, MD, +48426895341, aleksanderwkowal@gmail.com
Recruiting

Other trials in Poland

About this study

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

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.

Conditions: Lower Back Pain Chronic, Lumbar Degenerative Disease, Lumbar Disc Degeneration, Degenerative Disc Disease(DDD)
Being tested: Midline Lumbar Interbody Fusion (MIDLIF), Minimally Invasive Transforaminal Lumbar Interbody Fusion (mini-TLIF)
Keywords: Degenerative Disc Disease, Lower Back Pain, Lumbar Disc Degeneration, Discogenic Pain, MIS-TLIF, MIDLIF, mini-TLIF, Minimally Invasive Transforaminal Lumbar Interbody Fusion, Midline Lumbar Interbody Fusion, Spinal stabilization, Spinal fusion
Medical subject headings: Intervertebral Disc Degeneration, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Midline Lumbar Interbody Fusion (MIDLIF)Procedure or surgery
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)Procedure or surgery
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.

Study groups in NCT07127380
Study group	Role	What they receive
Minimally Invasive Transforaminal Lumbar Interbody Fusion (mini-TLIF)	Active comparator	Lumbar fusion is obatained by Minimally Invasive Transforaminal Lumbar Interbody Fusion Receives: Procedure: Minimally Invasive Transforaminal Lumbar Interbody Fusion (mini-TLIF)
Midline Lumbar Interbody Fusion (MIDLIF)	Experimental	Lumbar fusion is obtained by Midline Lumbar Interbody Fusion Receives: Procedure: Midline Lumbar Interbody Fusion (MIDLIF)

What is being measured

The primary outcome is the main question the study is designed to answer.

Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is a measurement tool designed to quantify subjective pain intensity. It consists of a straight horizontal line, typically 10 cm (100 mm) long, with two endpoints anchored by descriptive labels ("no pain" on the left and "worst imaginable pain" on the right). Respondents mark a point on the line that best represents their perception, and the score is determined by measuring the distance in millimeters from the left endpoint to the mark, yielding a continuous score from 0 to 100.
Measured: 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)
The Numeric Rating Scale (NRS) is a unidimensional, self-reported psychometric tool primarily used to quantify the intensity of pain on a numerical scale. It typically consists of an 11-point scale ranging from 0 to 10, where 0 represents "no pain" (or no symptom) and 10 represents "worst possible pain" (or maximum intensity imaginable). Respondents verbally or in writing select a whole number that best reflects their current experience, making it a discrete rather than continuous measure.
Measured: 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
The Core Outcome Measures Index (COMI) is a multidimensional, patient-reported outcome measure designed to assess the key domains affected by spinal disorders, particularly low back pain and related conditions. It consists of a brief questionnaire (typically 7-8 items) that evaluates pain intensity, function, symptom-specific well-being, general quality of life, and disability (both social and work-related). Responses are scored on a 0-10 scale, where higher scores indicate worse outcomes; the overall COMI score is the average of the domain scores, providing a single summary index.
Measured: 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)
The Oswestry Disability Index (ODI) is a self-reported questionnaire designed to quantify the level of functional disability associated with low back pain and related spinal conditions. It consists of 10 sections, each addressing a specific aspect of daily life impacted by pain: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life (optional in some versions), social life, and traveling. Each section has 6 statements scored from 0 (no limitation) to 5 (maximum limitation), with the total score expressed as a percentage (0-100%), where higher scores indicate greater disability. Common interpretations include 0-20% (minimal disability), 21-40% (moderate), 41-60% (severe), 61-80% (crippled), and 81-100% (bed-bound or exaggerating symptoms).
Measured: 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
The European Quality of Life - 5 Dimensions, 5 Levels (EQ-5D-5L) is a standardized, self-reported instrument developed by the EuroQol Group to measure health-related quality of life (HRQoL) across a wide range of populations and conditions. It comprises two main components: a descriptive system with five health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on five levels of severity.
Measured: 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 outcomes (8)

Complication Rates and Types
Evaluation of the frequency and nature of complications between groups, including nerve root damage, cerebrospinal fluid leak, instrumentation failure, postoperative wound infection, and other adverse events.
Measured: 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
Analysis of direct treatment costs with a breakdown by category, including total hospitalization costs, costs of implants used, costs of medications administered, and costs of the surgical procedure.
Measured: 12 months after randomization
Hospitalization Duration
Measurement of the length of stay (LOS) in the hospital.
Measured: 2 days after randomization (day of hospital discharge)
Procedure Duration
Evaluation of the operating room time (OR time) required for the surgery.
Measured: 2 days after randomization
Blood Loss
Quantification of estimated blood loss (EBL) during the surgical procedure.
Measured: 2 days after randomization
Spinal Morphometric Parameters
Evaluation of intervertebral space height (ISH), foraminal height (FH), radiological evidence of bone fusion, and global and segmental lordosis of the lumbar-sacral spine.
Measured: 2 days after randomization, 3 months after randomization, 12 months after randomization
Time to Return to Professional Activity
Measurement of the duration required for working patients to resume professional activities.
Measured: 12 months after randomization
Radiological Assessment of Adjacent Segment Disease
Evaluation of the occurrence of adjacent segment disease based on MRI of the lumbar-sacral spine.
Measured: 12 months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jan 202531 Jan 2028

First posted17 Aug 2025
Study start19 Jan 2025
Primary completion19 Jan 2028 (estimated)
Study completion31 Jan 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Lower Back Pain ChronicStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07127380
Sponsor's protocol ID: 112/2024
Acronym: MID-MIS
Status last verified: Aug 2025
First submitted: 11 Aug 2025
Last updated: 15 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 34603954
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.
PubMed 39333680
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.
PubMed 38725087
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.
PubMed 31650331
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.
PubMed 35442112
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.
PubMed 34551928
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.
PubMed 29858673
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.
PubMed 27683674

Interested in taking part?

Aleksander Kowal, MD

+48426895341

aleksanderwkowal@gmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Enrolling by invitation
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Osteoarthritis, Knee, Diabetic Neuropathic Pain

All Lower Back Pain Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT07127380
Acronym / sponsor ID: MID-MIS / 112/2024
Conditions: Lower Back Pain Chronic, Lumbar Degenerative Disease, Lumbar Disc Degeneration, Degenerative Disc Disease(DDD)
Keywords: Degenerative Disc Disease, Lower Back Pain, Lumbar Disc Degeneration, Discogenic Pain, MIS-TLIF, MIDLIF, mini-TLIF, Minimally Invasive Transforaminal Lumbar Interbody Fusion
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 100 participants (estimated)
Lead sponsor: Copernicus Memorial HospitalUniversity, hospital or other
Study start: 19 Jan 2025 (actual)
Primary completion: 19 Jan 2028 (estimated)
Study completion: 31 Jan 2028 (estimated)
First posted: 17 Aug 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Background

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Minimally Invasive Transforaminal Lumbar Interbody Fusion (mini-TLIF)	Active comparator	Procedure: Minimally Invasive Transforaminal Lumbar Interbody Fusion (mini-TLIF)Lumbar fusion is obatained by Minimally Invasive Transforaminal Lumbar Interbody Fusion
Midline Lumbar Interbody Fusion (MIDLIF)	Experimental	Procedure: Midline Lumbar Interbody Fusion (MIDLIF)Lumbar fusion is obtained by Midline Lumbar Interbody Fusion

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Procedure or surgery	Midline Lumbar Interbody Fusion (MIDLIF)
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.	Procedure or surgery	Minimally Invasive Transforaminal Lumbar Interbody Fusion (mini-TLIF)

Primary outcome

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
The Visual Analog Scale (VAS) is a measurement tool designed to quantify subjective pain intensity. It consists of a straight horizontal line, typically 10 cm (100 mm) long, with two endpoints anchored by descriptive labels ("no pain" on the left and "worst imaginable pain" on the right). Respondents mark a point on the line that best represents their perception, and the score is determined by measuring the distance in millimeters from the left endpoint to the mark, yielding a continuous score from 0 to 100.
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
The Numeric Rating Scale (NRS) is a unidimensional, self-reported psychometric tool primarily used to quantify the intensity of pain on a numerical scale. It typically consists of an 11-point scale ranging from 0 to 10, where 0 represents "no pain" (or no symptom) and 10 represents "worst possible pain" (or maximum intensity imaginable). Respondents verbally or in writing select a whole number that best reflects their current experience, making it a discrete rather than continuous measure.
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
The Core Outcome Measures Index (COMI) is a multidimensional, patient-reported outcome measure designed to assess the key domains affected by spinal disorders, particularly low back pain and related conditions. It consists of a brief questionnaire (typically 7-8 items) that evaluates pain intensity, function, symptom-specific well-being, general quality of life, and disability (both social and work-related). Responses are scored on a 0-10 scale, where higher scores indicate worse outcomes; the overall COMI score is the average of the domain scores, providing a single summary index.
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
The Oswestry Disability Index (ODI) is a self-reported questionnaire designed to quantify the level of functional disability associated with low back pain and related spinal conditions. It consists of 10 sections, each addressing a specific aspect of daily life impacted by pain: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life (optional in some versions), social life, and traveling. Each section has 6 statements scored from 0 (no limitation) to 5 (maximum limitation), with the total score expressed as a percentage (0-100%), where higher scores indicate greater disability. Common interpretations include 0-20% (minimal disability), 21-40% (moderate), 41-60% (severe), 61-80% (crippled), and 81-100% (bed-bound or exaggerating symptoms).
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
The European Quality of Life - 5 Dimensions, 5 Levels (EQ-5D-5L) is a standardized, self-reported instrument developed by the EuroQol Group to measure health-related quality of life (HRQoL) across a wide range of populations and conditions. It comprises two main components: a descriptive system with five health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on five levels of severity.

8 secondary outcomes

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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
Background: PubMed 37422769Silva 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.
Background: PubMed 40315609Tippins 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.
Background: PubMed 31535047Crawford 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.
Background: PubMed 21506066Parker 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.
Background: PubMed 27503024Xie 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.
Background: PubMed 34602458Xue 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.
Background: PubMed 34273567Heemskerk 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.
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Background: PubMed 39333680Zhang 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.
Background: PubMed 38725087Wang 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.
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Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Aleksander Kowal, MD contact

+48426895341

aleksanderwkowal@gmail.com

Kamil Krystkiewicz, MD, PhD contact

+48426895341

kamil.krystkiewicz@gmail.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aleksander Kowal, MD (+48426895341, aleksanderwkowal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07127380, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.