Sagittal Parameters After Mono Segmental Lumber Fusion: Interbody Versus Postrolateral Fusion

NCT ID: NCT03877341

Last Updated: 2023-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2023-03-01

Brief Summary

To compare postoperative radiographic sagittal parameters after monosegmental lumbar fusion: posterior lumbar interbody fusion versus postrolateral fusion in treatment of lumbar spine instability

Detailed Description

The term "spondylolisthesis" refers to slipping of a vertebra relative to an adjacent vertebra,and there are two mean types degenerative and lytic : Degenerative spondylolisthesis is secondary to osteoarthritis leading to facet incompetence and disc degeneration.This condition allows anterior translation of one vertebra on another. Spondylolysis is the break in the pars interarticularis and is the precursor of lytic spondylolisthesis which associated with a pars fracture When nonoperative care fails and surgery is being considered, the type of fusion should be tailored to the specific pathology being treated.So there are different operations to correct this instability like postrolateral fusion (PLF) and posterior lumber interbody fusion (PLIF) PLF decreases segmental motion in the posterior column, which presumably reduces facet joint pain.Theoretical advantages of PLIF include decompression of exiting nerve roots by distraction of the collapsed disc space, achievement of optimal fusion in relation to the load-bearing capacity of the vertebral bodies and possibly attainment of a better fusion rate

Conditions

Lumbar Spine Fusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PLF

posterolateral fusion

Group Type: ACTIVE_COMPARATOR

posterolateral fusion

Intervention Type: PROCEDURE

Instrumented posterolateral fusion is a spinal surgery that combines bone graft fusion with the use of hardware like screws and rods to stabilize the spine, correct alignment, and promote successful fusion. It's used for various spinal conditions.

PLIF

posterior lumbar interbody fusion

Group Type: ACTIVE_COMPARATOR

posterior lumbar interbody fusion

Intervention Type: PROCEDURE

Posterior lumbar interbody fusion (PLIF) is a spinal surgery that involves removing problematic discs, inserting bone graft material, and sometimes a spacer, to promote fusion and stabilize the spine.

Interventions

posterolateral fusion

Instrumented posterolateral fusion is a spinal surgery that combines bone graft fusion with the use of hardware like screws and rods to stabilize the spine, correct alignment, and promote successful fusion. It's used for various spinal conditions.

Intervention Type: PROCEDURE

posterior lumbar interbody fusion

Posterior lumbar interbody fusion (PLIF) is a spinal surgery that involves removing problematic discs, inserting bone graft material, and sometimes a spacer, to promote fusion and stabilize the spine.

Intervention Type: PROCEDURE

Other Intervention Names

PLF; PLIF

Eligibility Criteria

Inclusion Criteria

• Adult patient older of 18 years old.
• Patients with lytic spondylolisthesis
• Low grade spondylolisthsis 1,2

Exclusion Criteria

• Traumatic spondylolysis
• Previous spine surgery.
• Patient younger 18 years old
• High grade spondylolisthsis 3,4,5 - multiple levels spondylolithises

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Fady Samy saeed

resident assiut university hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

mahmoud fouad, lecturer

Role: STUDY_DIRECTOR

assuit university hospitals

Locations

Assiut University Hospitals

Asyut, , Egypt

Countries

Egypt

References

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Reference Type: BACKGROUND

PMID: 27683674 (View on PubMed)

Madan S, Boeree NR. Outcome of posterior lumbar interbody fusion versus posterolateral fusion for spondylolytic spondylolisthesis. Spine (Phila Pa 1976). 2002 Jul 15;27(14):1536-42. doi: 10.1097/00007632-200207150-00011.

Reference Type: BACKGROUND

PMID: 12131714 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 13035484 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 19468868 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 2071615 (View on PubMed)

Feffer HL, Wiesel SW, Cuckler JM, Rothman RH. Degenerative spondylolisthesis. To fuse or not to fuse. Spine (Phila Pa 1976). 1985 Apr;10(3):287-9.

Reference Type: BACKGROUND

PMID: 3992350 (View on PubMed)

Lidar Z, Beaumont A, Lifshutz J, Maiman DJ. Clinical and radiological relationship between posterior lumbar interbody fusion and posterolateral lumbar fusion. Surg Neurol. 2005 Oct;64(4):303-8; discussion 308. doi: 10.1016/j.surneu.2005.03.025.

Reference Type: BACKGROUND

PMID: 16181997 (View on PubMed)

Hu SS, Tribus CB, Diab M, Ghanayem AJ. Spondylolisthesis and spondylolysis. J Bone Joint Surg Am. 2008 Mar;90(3):656-71. No abstract available.

Reference Type: BACKGROUND

PMID: 18326106 (View on PubMed)

Other Identifiers

17100676

Identifier Type: -

Identifier Source: org_study_id