NCT07312747

Brief 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 migration, subsidence, pseudoarthrosis, and adjacent segment degeneration and analyze differences in operative time, blood loss, and length of hospital stay between the two techniques

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
21mo left

Started Jan 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Jan 2026Feb 2028

First Submitted

Initial submission to the registry

November 21, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 31, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

2 years

First QC Date

November 21, 2025

Last Update Submit

December 17, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • success rate of bilateral straight cages in lumbar fusion surgery

    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

    6 months Post operative

Study Arms (2)

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

Interventions

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

People with bilateral straight cagesPeople with unilateral banana cage

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic discogenic low back pain with Radiological evidence of disc degeneration, instability, or spondylolisthesis
  • Failed medical treatment \> 6 months

You may not qualify if:

  • Patients unfit for surgery .
  • Active spinal infection ,Osteoporosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at Neurosurgery Department, Assiut University

Study Record Dates

First Submitted

November 21, 2025

First Posted

December 31, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

December 31, 2025

Record last verified: 2025-12