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

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

Study Overview

• Status: Completed
• Conditions: Lumbar Spine Fusion
• Intervention / Treatment: Procedure: posterolateral fusion; Procedure: posterior lumbar interbody fusion

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

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Assiut University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

all patients with lytic spondylolithises low grade from age of 18 years old whatever sex

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PLF; posterolateral fusion	Procedure: 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.; Other Names: PLF
Active Comparator: PLIF; posterior lumbar interbody fusion	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.; Other Names: PLIF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spino sacral angle	Which is the angle fromed between the line from front side of t1 to the middle of sacrum and the line passing through the sacral plateau	6month post op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
T1 pelvic angle	The angle between the line from centroid of t1 to the femoral head axis and the line from femoral head axis to middle of the s1 end plate	Pre op. Post op immediately. 6month post op
Pelvic incidence	Is the angle between the line perpendicular to the s1 end plate from the midpoint of the end plate and the connecting line from the midpoint of the s1 end plate to center of the femoral head	Pre op. Post op immediately. 6month post op
Pelvic tilt	Is the angle between the connecting line from the midpoint of the s1 end plate to the center of the femoral head and the vertical line	Pre op. Post op immediately. 6month post op
Sacral slope	Is the angle between the tangent and the horizontal line of s1 end plate	Pre op. Post op immediately. 6month post op
Lumbar lordosis	Is the junction of the thoracic kyphosis to the s1 end plate	Pre op. Post op immediately. 6month post op

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: mahmoud fouad, lecturer, Assuit University hospitals

Publications and helpful links

General Publications

• Herkowitz HN, Kurz LT. Degenerative lumbar spondylolisthesis with spinal stenosis. A prospective study comparing decompression with decompression and intertransverse process arthrodesis. J Bone Joint Surg Am. 1991 Jul;73(6):802-8.
• Mobbs RJ, Phan K, Malham G, Seex K, Rao PJ. Lumbar interbody fusion: techniques, indications and comparison of interbody fusion options including PLIF, TLIF, MI-TLIF, OLIF/ATP, LLIF and ALIF. J Spine Surg. 2015 Dec;1(1):2-18. doi: 10.3978/j.issn.2414-469X.2015.10.05.
• Cole CD, McCall TD, Schmidt MH, Dailey AT. Comparison of low back fusion techniques: transforaminal lumbar interbody fusion (TLIF) or posterior lumbar interbody fusion (PLIF) approaches. Curr Rev Musculoskelet Med. 2009 Jun;2(2):118-26. doi: 10.1007/s12178-009-9053-8. Epub 2009 Apr 29.
• 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.
• 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.
• CLOWARD RB. The treatment of ruptured lumbar intervertebral discs by vertebral body fusion. I. Indications, operative technique, after care. J Neurosurg. 1953 Mar;10(2):154-68. doi: 10.3171/jns.1953.10.2.0154. No abstract available.
• Kuraishi S, Takahashi J, Mukaiyama K, Shimizu M, Ikegami S, Futatsugi T, Hirabayashi H, Ogihara N, Hashidate H, Tateiwa Y, Kinoshita H, Kato H. Comparison of Clinical and Radiological Results of Posterolateral Fusion and Posterior Lumbar Interbody Fusion in the Treatment of L4 Degenerative Lumbar Spondylolisthesis. Asian Spine J. 2016 Feb;10(1):143-52. doi: 10.4184/asj.2016.10.1.143. Epub 2016 Feb 16.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: March 4, 2019
• First Submitted That Met QC Criteria: March 14, 2019
• First Posted (Actual): March 15, 2019

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 17100676

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No