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

Lumbar Spine Fusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03877341
• Other study ID #: 17100676
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: March 1, 2023

Study information

• Verified date: September 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lumbar Spine Fusion

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Assiut University Hospitals	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Sacral slope	Is the angle between the tangent and the horizontal line of s1 end plate	Pre op. Post op immediately. 6month post op
Secondary	Lumbar lordosis	Is the junction of the thoracic kyphosis to the s1 end plate	Pre op. Post op immediately. 6month post op