Degenerative Spine DiseasesNCT06545032
Minimal Invasive Transforaminal Lumbar Interbody Fusion for Degenerative Lumbar and Lumbosacral Spine Diseases
A study testing lumbar fusion in people with Degenerative Spine Diseases, run by Sohag University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate clinical and surgical outcome of MI-TLIF for degenerative lumbar and lumbosacral spine diseases. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Degenerative Spine Diseases
- What is being tested?
- lumbar fusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2024to 10 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Degenerative spondylolisthesis.
- Degenerative unilateral disc herniations.
- Recurrent disc herniation.
Who cannot join
- Spondylolisthesis Grade III or IV.
- Degenerative scoliosis .
- Traumatic fracture spine.
- Infections.
- Neoplasms.
- Debilitated patients .
- Coagulation dysfunction.
- Severe osteoporosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minimal Invasive Transforaminal Lumbar Interbody Fusion for Degenerative Lumbar and Lumbosacral Spine Diseases : Clinical and Surgical Outcome
The aim of this study is to evaluate clinical and surgical outcome of MI-TLIF for degenerative lumbar and lumbosacral spine diseases.
Read the detailed description
Approximately 70% to 85% of adults were affected by low back pain (LBP) at some point during their lifetimes. Numerous anatomic sites can be responsible for the pain, and accurate diagnosis is often difficult. Degenerative lumbar, lumbosacral spine diseases internal disc disruption, lumbar disc herniation, and facet joint arthritis, as well as intra-abdominal pathology, are all potential causes of LBP(Stott and Driscoll, 2024). q Degenerative lumbar and lumbosacral spine diseases are the most rampantly prevalent healthcare problems in the world, with chronic LBP being the second leading cause of adult disability ,The symptoms can broadly be divided into LBP and radicular symptoms in the lower extremities leading in some cases to neurogenic claudication(Shokri et al., 2023).
As an alternative to PLIF, Harms and Rolinger introduced the transforaminal lumbar interbody fusion (TLIF) procedure in 1982 for the management of degenerative spinal disorders that necessitate interbody fusions. The impetus for the development of TLIF was to provide a more lateral approach to the disc space, thus reducing the amount of thecal sac and nerve root retraction. Additionally, in revision cases where scar tissue hinders identification of neural structures, avoidance of midline scar planes with the TLIF procedure is beneficial. Moreover, a circumferential fusion can be achieved from a unilateral approach with the TLIF procedure without having to expose the bilateral epidural space (Karikari, Isaac O. MD; Isaacs, Robert E. MD, 2010).
Technological advances, better magnification and illumination, modern tubular retractors and percutaneous screw systems and more frequent exposure of surgeons to minimally access surgery in their residency training has greatly contributed to the global success of minimal invasive transforaminal lumbar interbody fusion (MI-TLIF). Traditional open spinal fusion surgeries, while effective, are associated with considerable tissue disruption, prolonged recovery times, and higher risks of complications(Prabhu et al., 2022).
MI-TLIFis one such advanced surgical technique designed to treat degenerative conditions of lumbar and lumbosacral spine diseases. Through the tubular expander, MIS-TLIF can reach the facet joints of the diseased segments. MIS-TLIF effectively reduces the peeling and traction injury of the multifidus muscle, prevents postoperative muscle atrophy, and reduces the occurrence of postoperative chronic LBP(Saela et al., 2023).
The MI-TLIF has shown reduced complications, decreased intraoperative blood loss, shorter hospital stays and recovery time, and decreased postoperative narcotic usage while maintaining similar clinical outcomes and fusion rates to conventional open TLIF since its inception (Hong et al., 2022).
The success of MI-TLIF can be attributed to the following fundamental principles: (1) minimizing damage to soft tissues and avoiding destabilization of the spinal segment(s) to achieve the surgical goal with the smallest possible operative footprint; (2) utilizing a unilateral approach to achieve bilateral decompression when needed; and (3) achieving neural decompression indirectly. Although there is no definitive definition of MI-TLIF, the lack of a precise definition has led to significant variations in how surgeons perform the procedure due to various technical nuances associated with each step(Lener et al., 2020).
The use of minimally invasive surgical techniques represents the most recent modification of methods used to achieve lumbar interbody fusion, based upon the premise that a smaller, less traumatic incision should afford better recovery and outcomes(Jang et al., 2024).Hence, in our study we aim to evaluate MI-TLIF for degenerative lumbar and lumbosacral spine diseases.
- Conditions
- Degenerative Spine Diseases
- Being tested
- lumbar fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar fusionProcedure or surgery
Minimal Invasive Transforaminal Lumbar Interbody Fusion
| Study group | Role | What they receive |
|---|---|---|
| Minimal Invasive Transforaminal Lumbar Interbody Fusion | Active comparator | Not described Receives: Procedure: lumbar fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of pain according to visual analog score(vas)
comparison between pre \& post operative pain
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start15 Sep 2024
- Primary completion5 Sep 2026
- Study completion10 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Degenerative Spine DiseasesStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelaleem Mohamed Abdelrahman, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545032
- Sponsor's protocol ID
- soh-med-24-07-3MD
- Status last verified
- Sep 2026
- First submitted
- 6 Aug 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.
PubMed 11074683Hong JY, Kim WS, Park J, Kim CH, Jang HD. Comparison of minimally invasive and open TLIF outcomes with more than seven years of follow-up. N Am Spine Soc J. 2022 Jun 11;11:100131. doi: 10.1016/j.xnsj.2022.100131. eCollection 2022 Sep.
PubMed 35783004Jang HD, Lee JC, Choi SW, Hong CH, Suh YS, Shin BJ. A novel surgical approach using the "lateral corridor" for minimally invasive oblique lumbar interbody fusion at L5-S1: a clinical series and technical note. Eur Spine J. 2024 Jul;33(7):2611-2620. doi: 10.1007/s00586-024-08217-6. Epub 2024 May 31.
PubMed 38819738Le H, Anderson R, Phan E, Wick J, Barber J, Roberto R, Klineberg E, Javidan Y. Clinical and Radiographic Comparison Between Open Versus Minimally Invasive Transforaminal Lumbar Interbody Fusion With Bilateral Facetectomies. Global Spine J. 2021 Jul;11(6):903-910. doi: 10.1177/2192568220932879. Epub 2020 Jun 22.
PubMed 32677520
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Invasive Transforaminal Lumbar Interbody Fusion for Degenerative Lumbar and Lumbosacral Spine Diseases : Clinical and Surgical Outcome
- ClinicalTrials.gov ID
- NCT06545032
- Acronym / sponsor ID
- soh-med-24-07-3MD
- Conditions
- Degenerative Spine Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 5 Sep 2026 (actual)
- Study completion
- 10 Sep 2026 (actual)
- First posted
- 9 Aug 2024 (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.
The aim of this study is to evaluate clinical and surgical outcome of MI-TLIF for degenerative lumbar and lumbosacral spine diseases.
Detailed description
Approximately 70% to 85% of adults were affected by low back pain (LBP) at some point during their lifetimes. Numerous anatomic sites can be responsible for the pain, and accurate diagnosis is often difficult. Degenerative lumbar, lumbosacral spine diseases internal disc disruption, lumbar disc herniation, and facet joint arthritis, as well as intra-abdominal pathology, are all potential causes of LBP(Stott and Driscoll, 2024). q Degenerative lumbar and lumbosacral spine diseases are the most rampantly prevalent healthcare problems in the world, with chronic LBP being the second leading cause of adult disability ,The symptoms can broadly be divided into LBP and radicular symptoms in the lower extremities leading in some cases to neurogenic claudication(Shokri et al., 2023).
As an alternative to PLIF, Harms and Rolinger introduced the transforaminal lumbar interbody fusion (TLIF) procedure in 1982 for the management of degenerative spinal disorders that necessitate interbody fusions. The impetus for the development of TLIF was to provide a more lateral approach to the disc space, thus reducing the amount of thecal sac and nerve root retraction. Additionally, in revision cases where scar tissue hinders identification of neural structures, avoidance of midline scar planes with the TLIF procedure is beneficial. Moreover, a circumferential fusion can be achieved from a unilateral approach with the TLIF procedure without having to expose the bilateral epidural space (Karikari, Isaac O. MD; Isaacs, Robert E. MD, 2010).
Technological advances, better magnification and illumination, modern tubular retractors and percutaneous screw systems and more frequent exposure of surgeons to minimally access surgery in their residency training has greatly contributed to the global success of minimal invasive transforaminal lumbar interbody fusion (MI-TLIF). Traditional open spinal fusion surgeries, while effective, are associated with considerable tissue disruption, prolonged recovery times, and higher risks of complications(Prabhu et al., 2022).
MI-TLIFis one such advanced surgical technique designed to treat degenerative conditions of lumbar and lumbosacral spine diseases. Through the tubular expander, MIS-TLIF can reach the facet joints of the diseased segments. MIS-TLIF effectively reduces the peeling and traction injury of the multifidus muscle, prevents postoperative muscle atrophy, and reduces the occurrence of postoperative chronic LBP(Saela et al., 2023).
The MI-TLIF has shown reduced complications, decreased intraoperative blood loss, shorter hospital stays and recovery time, and decreased postoperative narcotic usage while maintaining similar clinical outcomes and fusion rates to conventional open TLIF since its inception (Hong et al., 2022).
The success of MI-TLIF can be attributed to the following fundamental principles: (1) minimizing damage to soft tissues and avoiding destabilization of the spinal segment(s) to achieve the surgical goal with the smallest possible operative footprint; (2) utilizing a unilateral approach to achieve bilateral decompression when needed; and (3) achieving neural decompression indirectly. Although there is no definitive definition of MI-TLIF, the lack of a precise definition has led to significant variations in how surgeons perform the procedure due to various technical nuances associated with each step(Lener et al., 2020).
The use of minimally invasive surgical techniques represents the most recent modification of methods used to achieve lumbar interbody fusion, based upon the premise that a smaller, less traumatic incision should afford better recovery and outcomes(Jang et al., 2024).Hence, in our study we aim to evaluate MI-TLIF for degenerative lumbar and lumbosacral spine diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minimal Invasive Transforaminal Lumbar Interbody Fusion | Active comparator | Procedure: lumbar fusion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Degenerative spondylolisthesis.
- Degenerative unilateral disc herniations.
- Recurrent disc herniation.
Key exclusion criteria (8 listed)
- Spondylolisthesis Grade III or IV.
- Degenerative scoliosis .
- Traumatic fracture spine.
- Infections.
- Neoplasms.
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 |
|---|---|---|
| lumbar fusionMinimal Invasive Transforaminal Lumbar Interbody Fusion | Procedure or surgery | Minimal Invasive Transforaminal Lumbar Interbody Fusion |
Primary outcome
severity of pain according to visual analog score(vas)
Time frame: 1 year
comparison between pre \& post operative pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 11074683Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.
- Background: PubMed 35783004Hong JY, Kim WS, Park J, Kim CH, Jang HD. Comparison of minimally invasive and open TLIF outcomes with more than seven years of follow-up. N Am Spine Soc J. 2022 Jun 11;11:100131. doi: 10.1016/j.xnsj.2022.100131. eCollection 2022 Sep.
- Background: PubMed 38819738Jang HD, Lee JC, Choi SW, Hong CH, Suh YS, Shin BJ. A novel surgical approach using the "lateral corridor" for minimally invasive oblique lumbar interbody fusion at L5-S1: a clinical series and technical note. Eur Spine J. 2024 Jul;33(7):2611-2620. doi: 10.1007/s00586-024-08217-6. Epub 2024 May 31.
- Background: PubMed 32677520Le H, Anderson R, Phan E, Wick J, Barber J, Roberto R, Klineberg E, Javidan Y. Clinical and Radiographic Comparison Between Open Versus Minimally Invasive Transforaminal Lumbar Interbody Fusion With Bilateral Facetectomies. Global Spine J. 2021 Jul;11(6):903-910. doi: 10.1177/2192568220932879. Epub 2020 Jun 22.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lumbar fusion in people with Degenerative Spine Diseases, run by Sohag University at 1 site in Egypt.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 17 Sep 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severity of pain according to visual analog score(vas) (time frame: 1 year). 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 NCT06545032, which also lists 4 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 17 Sep 2026.