Lumbar Disc HerniationNCT07312747
Comparison Between Insertion of Bilateral Straight Cages Versus Unilateral Banana Cage in Lumbar Fusion Surgery
A study testing cages in lumbar fusion surgery in people with Lumbar Disc Herniation, run by Assiut University.
Trial summary
To compare the clinical outcomes of bilateral straight cages and unilateral banana cage insertion in lumbar interbody fusion surgery, assess radiological outcomes, including intervertebral disc height, lumbar lordosis angle, and radiographic evidence of fusion, evaluate the rate of complications, such as cage… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- cages in lumbar fusion surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Feb 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Symptomatic discogenic low back pain with Radiological evidence of disc degeneration, instability, or spondylolisthesis
- Failed medical treatment > 6 months
Who cannot join
- • Patients unfit for surgery .
- Active spinal infection ,Osteoporosis
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
- To compare the clinical outcomes of bilateral straight cages and unilateral banana cage insertion in lumbar interbody fusion surgery, assess radiological outcomes, including intervertebral disc height, lumbar lordosis angle, and radiographic evidence of fusion, evaluate the rate of complications, such as cage migration, subsidence, pseudoarthrosis, and adjacent segment degeneration and analyze differences in operative time, blood loss, and length of hospital stay between the two techniques
Read the detailed description
Lumbar fusion surgery is a widely utilized procedure for the treatment of a variety of spinal pathologies, including degenerative disc disease, lumbar spondylolisthesis, and spinal instability. Among the surgical techniques available, transforaminal lumbar interbody fusion (TLIF) has gained prominence due to its ability to access the disc space through a posterior approach, reduce neural retraction, and allow for thorough disc removal and interbody cage placement with minimal disruption to the spinal canal.(1)
A critical factor in TLIF procedures is the type and positioning of the interbody cage. Traditionally, bilateral straight cages have been inserted to promote symmetrical load sharing and increase the surface area for fusion. This technique aims to ensure even support of the anterior column and reduce the risk of cage subsidence or pseudarthrosis. On the other hand, unilateral insertion of banana-shaped cages has been introduced as a potentially less invasive alternative that simplifies the procedure while still achieving adequate segmental stability and fusion.(2,3) Despite growing adoption of both bilateral straight and unilateral banana cages, controversy remains regarding their relative biomechanical performance, clinical efficacy, and complication profiles. Factors such as asymmetrical load distribution in unilateral constructs, differences in cage surface area contact, and potential risks for adjacent segment degeneration or cage migration have yet to be definitively resolved through high-quality comparative studies.(4,5) This study protocol aims to compare the outcomes of bilateral straight cage versus unilateral banana cage insertion in lumbar spine fusion surgery. By evaluating parameters such as fusion rate, operative time, blood loss, cage subsidence, and patient-reported outcomes, the study will provide evidence-based insights to guide surgical technique selection and improve long-term outcomes for patients undergoing lumbar spine fusion surgery .(6,7)
- Conditions
- Lumbar Disc Herniation
- Being tested
- cages in lumbar fusion surgery
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cages in lumbar fusion surgeryProcedure or surgery
A critical factor in TLIF procedures is the type and positioning of the interbody cage. Traditionally, bilateral straight cages have been inserted to promote symmetrical load sharing and increase the surface area for fusion. This technique aims to ensure even support of the anterior column and reduce the risk of cage subsidence or pseudarthrosis. On the other hand, unilateral insertion of banana-shaped cages has been introduced as a potentially less invasive alternative that simplifies the procedure while still achieving adequate segmental stability and fusion
| Study group | Role | What they receive |
|---|---|---|
| People with bilateral straight cages | Active comparator | Not described Receives: Procedure: cages in lumbar fusion surgery |
| People with unilateral banana cage | Active comparator | Not described Receives: Procedure: cages in lumbar fusion surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate of bilateral straight cages in lumbar fusion surgery
Percentage of success of bilateral straight cages in lumbar fusion surgery
Measured: 6 months post operative
Percentage of success of unilateral banana cage in lumbar fusion surgery
Measured: 6 months Post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Osman Ahmed Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312747
- Sponsor's protocol ID
- type of cages in lumbar fusion
- Status last verified
- Dec 2025
- First submitted
- 21 Nov 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lang G, Perrech M, Navarro-Ramirez R, Hussain I, Pennicooke B, Maryam F, Avila MJ, Hartl R. Potential and Limitations of Neural Decompression in Extreme Lateral Interbody Fusion-A Systematic Review. World Neurosurg. 2017 May;101:99-113. doi: 10.1016/j.wneu.2017.01.080. Epub 2017 Jan 31.
PubMed 28153620Yoon J, Choi HY, Jo DJ. Comparison of Outcomes of Multi-Level Anterior, Oblique, Transforaminal Lumbar Interbody Fusion Surgery : Impact on Global Sagittal Alignment. J Korean Neurosurg Soc. 2023 Jan;66(1):33-43. doi: 10.3340/jkns.2022.0112. Epub 2022 Aug 23.
PubMed 35996945Della Pepa GM, La Rocca G, Barbagallo G, Spallone A, Visocchi M. Transient breathing disorders after posterior cervical surgery for degenerative diseases: pathophysiological interpretation. Eur Rev Med Pharmacol Sci. 2014;18(1 Suppl):89-92.
PubMed 24825050Ke W, Zhang T, Wang B, Hua W, Wang K, Cheung JPY, Yang C. Biomechanical Comparison of Different Surgical Approaches for the Treatment of Adjacent Segment Diseases after Primary Transforaminal Lumbar Interbody Fusion: A Finite Element Analysis. Orthop Surg. 2023 Oct;15(10):2701-2708. doi: 10.1111/os.13866. Epub 2023 Aug 24.
PubMed 37620961Malham GM, Ellis NJ, Parker RM, Seex KA. Clinical outcome and fusion rates after the first 30 extreme lateral interbody fusions. ScientificWorldJournal. 2012;2012:246989. doi: 10.1100/2012/246989. Epub 2012 Nov 1.
PubMed 23213282Drossopoulos PN, Ononogbu-Uche FC, Tabarestani TQ, Huang CC, Paturu M, Bardeesi A, Ray WZ, Shaffrey CI, Goodwin CR, Erickson M, Chi JH, Abd-El-Barr MM. Evolution of the Transforaminal Lumbar Interbody Fusion (TLIF): From Open to Percutaneous to Patient-Specific. J Clin Med. 2024 Apr 14;13(8):2271. doi: 10.3390/jcm13082271.
PubMed 38673544Daher M, Aoun M, El-Sett P, Kreichati G, Kharrat K, Sebaaly A. Unilateral Versus Bilateral Cages in Lumbar Interbody Fusions: A Meta-Analysis of Clinical and Radiographic Outcomes. World Neurosurg. 2024 Jun;186:158-164. doi: 10.1016/j.wneu.2024.03.142. Epub 2024 Mar 30.
PubMed 38561031
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Insertion of Bilateral Straight Cages Versus Unilateral Banana Cage in Lumbar Fusion Surgery
- ClinicalTrials.gov ID
- NCT07312747
- Acronym / sponsor ID
- type of cages in lumbar fusion
- Conditions
- Lumbar Disc Herniation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 31 Dec 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.
- To compare the clinical outcomes of bilateral straight cages and unilateral banana cage insertion in lumbar interbody fusion surgery, assess radiological outcomes, including intervertebral disc height, lumbar lordosis angle, and radiographic evidence of fusion, evaluate the rate of complications, such as cage migration, subsidence, pseudoarthrosis, and adjacent segment degeneration and analyze differences in operative time, blood loss, and length of hospital stay between the two techniques
Detailed description
Lumbar fusion surgery is a widely utilized procedure for the treatment of a variety of spinal pathologies, including degenerative disc disease, lumbar spondylolisthesis, and spinal instability. Among the surgical techniques available, transforaminal lumbar interbody fusion (TLIF) has gained prominence due to its ability to access the disc space through a posterior approach, reduce neural retraction, and allow for thorough disc removal and interbody cage placement with minimal disruption to the spinal canal.(1)
A critical factor in TLIF procedures is the type and positioning of the interbody cage. Traditionally, bilateral straight cages have been inserted to promote symmetrical load sharing and increase the surface area for fusion. This technique aims to ensure even support of the anterior column and reduce the risk of cage subsidence or pseudarthrosis. On the other hand, unilateral insertion of banana-shaped cages has been introduced as a potentially less invasive alternative that simplifies the procedure while still achieving adequate segmental stability and fusion.(2,3) Despite growing adoption of both bilateral straight and unilateral banana cages, controversy remains regarding their relative biomechanical performance, clinical efficacy, and complication profiles. Factors such as asymmetrical load distribution in unilateral constructs, differences in cage surface area contact, and potential risks for adjacent segment degeneration or cage migration have yet to be definitively resolved through high-quality comparative studies.(4,5) This study protocol aims to compare the outcomes of bilateral straight cage versus unilateral banana cage insertion in lumbar spine fusion surgery. By evaluating parameters such as fusion rate, operative time, blood loss, cage subsidence, and patient-reported outcomes, the study will provide evidence-based insights to guide surgical technique selection and improve long-term outcomes for patients undergoing lumbar spine fusion surgery .(6,7)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People with bilateral straight cages | Active comparator | Procedure: cages in lumbar fusion surgery |
| People with unilateral banana cage | Active comparator | Procedure: cages in lumbar fusion surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- • Symptomatic discogenic low back pain with Radiological evidence of disc degeneration, instability, or spondylolisthesis
Key exclusion criteria (2 listed)
- • Patients unfit for surgery .
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 |
|---|---|---|
| cages in lumbar fusion surgeryA critical factor in TLIF procedures is the type and positioning of the interbody cage. Traditionally, bilateral straight cages have been inserted to promote symmetrical load sharing and increase the surface area for fusion. This technique aims to ensure even support of the anterior column and reduce the risk of cage subsidence or pseudarthrosis. On the other hand, unilateral insertion of banana-shaped cages has been introduced as a potentially less invasive alternative that simplifies the procedure while still achieving adequate segmental stability and fusion | Procedure or surgery | People with bilateral straight cages, People with unilateral banana cage |
Primary outcome
success rate of bilateral straight cages in lumbar fusion surgery
Time frame: 6 months post operative
Percentage of success of bilateral straight cages in lumbar fusion surgery
Percentage of success of unilateral banana cage in lumbar fusion surgery
Time frame: 6 months Post operative
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 31 Dec 2025.
- Results publication: PubMed 28153620Lang G, Perrech M, Navarro-Ramirez R, Hussain I, Pennicooke B, Maryam F, Avila MJ, Hartl R. Potential and Limitations of Neural Decompression in Extreme Lateral Interbody Fusion-A Systematic Review. World Neurosurg. 2017 May;101:99-113. doi: 10.1016/j.wneu.2017.01.080. Epub 2017 Jan 31.
- Results publication: PubMed 35996945Yoon J, Choi HY, Jo DJ. Comparison of Outcomes of Multi-Level Anterior, Oblique, Transforaminal Lumbar Interbody Fusion Surgery : Impact on Global Sagittal Alignment. J Korean Neurosurg Soc. 2023 Jan;66(1):33-43. doi: 10.3340/jkns.2022.0112. Epub 2022 Aug 23.
- Results publication: PubMed 24825050Della Pepa GM, La Rocca G, Barbagallo G, Spallone A, Visocchi M. Transient breathing disorders after posterior cervical surgery for degenerative diseases: pathophysiological interpretation. Eur Rev Med Pharmacol Sci. 2014;18(1 Suppl):89-92.
- Results publication: PubMed 37620961Ke W, Zhang T, Wang B, Hua W, Wang K, Cheung JPY, Yang C. Biomechanical Comparison of Different Surgical Approaches for the Treatment of Adjacent Segment Diseases after Primary Transforaminal Lumbar Interbody Fusion: A Finite Element Analysis. Orthop Surg. 2023 Oct;15(10):2701-2708. doi: 10.1111/os.13866. Epub 2023 Aug 24.
- Results publication: PubMed 23213282Malham GM, Ellis NJ, Parker RM, Seex KA. Clinical outcome and fusion rates after the first 30 extreme lateral interbody fusions. ScientificWorldJournal. 2012;2012:246989. doi: 10.1100/2012/246989. Epub 2012 Nov 1.
- Results publication: PubMed 38673544Drossopoulos PN, Ononogbu-Uche FC, Tabarestani TQ, Huang CC, Paturu M, Bardeesi A, Ray WZ, Shaffrey CI, Goodwin CR, Erickson M, Chi JH, Abd-El-Barr MM. Evolution of the Transforaminal Lumbar Interbody Fusion (TLIF): From Open to Percutaneous to Patient-Specific. J Clin Med. 2024 Apr 14;13(8):2271. doi: 10.3390/jcm13082271.
- Results publication: PubMed 38561031Daher M, Aoun M, El-Sett P, Kreichati G, Kharrat K, Sebaaly A. Unilateral Versus Bilateral Cages in Lumbar Interbody Fusions: A Meta-Analysis of Clinical and Radiographic Outcomes. World Neurosurg. 2024 Jun;186:158-164. doi: 10.1016/j.wneu.2024.03.142. Epub 2024 Mar 30.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing cages in lumbar fusion surgery in people with Lumbar Disc Herniation, run by Assiut University.
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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Ahmed osman ahmed (01091587175 ext. 02, Ahmed.17289908@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate of bilateral straight cages in lumbar fusion surgery (time frame: 6 months post operative). The study lists 2 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 NCT07312747, which also lists 7 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 31 Dec 2025.