- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07312747
Comparison Between Insertion of Bilateral Straight Cages Versus Unilateral Banana Cage in Lumbar Fusion Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmed osman ahmed
- Phone Number: 02 01091587175
- Email: Ahmed.17289908@med.aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Symptomatic discogenic low back pain with Radiological evidence of disc degeneration, instability, or spondylolisthesis
- Failed medical treatment > 6 months
Exclusion Criteria:
• Patients unfit for surgery .
- Active spinal infection ,Osteoporosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: People with bilateral straight cages
|
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
|
|
Active Comparator: People with unilateral banana cage
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
6 months post operative
|
|
Percentage of success of unilateral banana cage in lumbar fusion surgery
Time Frame: 6 months Post operative
|
6 months Post operative
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Yoon 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.
- Della 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.
- Ke 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.
- Malham 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.
- Drossopoulos 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.
- Daher 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- type of cages in lumbar fusion
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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