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

• ClinicalTrials.gov Identifier: NCT03877341
• Recruitment Status: Unknown
• First Posted: March 15, 2019
• Last Update Posted: March 15, 2019
• Sponsor: Assiut University
• Information provided by (Responsible Party): Fady Samy saeed, Assiut University

Study Description

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

Condition or disease	Intervention/treatment
Lumbar Spine Fusion	Device: X-RAY

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 Design

• Study Type: Observational
• Estimated Enrollment: 40 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Sagittal Parameters After Mono Segmental Lumber Fusion: Interbody Versus Postrolateral Fusion
• Estimated Study Start Date: April 1, 2019
• Estimated Primary Completion Date: March 1, 2020
• Estimated Study Completion Date: March 1, 2021

Groups and Cohorts

Intervention Details:

• Device: X-RAY
  x-ray on lumbosacral antro-posterior and lateral and dynamic veiws CT lumbosacral +mri lumbosacral
  Other Names:

  • CT
  • MRI

Outcome Measures

Primary Outcome Measures :

1. Spino sacral angle [ Time Frame: 6month post op ]
   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

Secondary Outcome Measures :

1. T1 pelvic angle [ Time Frame: Pre op. Post op immediately. 6month post op ]
   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
2. Pelvic incidence [ Time Frame: Pre op. Post op immediately. 6month post op ]
   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
3. Pelvic tilt [ Time Frame: Pre op. Post op immediately. 6month post op ]
   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
4. Sacral slope [ Time Frame: Pre op. Post op immediately. 6month post op ]
   Is the angle between the tangent and the horizontal line of s1 end plate
5. Lumbar lordosis [ Time Frame: Pre op. Post op immediately. 6month post op ]
   Is the junction of the thoracic kyphosis to the s1 end plate

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

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

Contacts and Locations

Contacts

Contact: Fady samy, resident; 01004114399; fadysamy771@gmail.com

Contact: khaled mohammed hassan, professor; 01005363318; khaledhtounes@yahoo.com

Sponsors and Collaborators

Assiut University

Investigators

• Study Director: mahmoud fouad, lecturer; assuit university hospitals

More Information

Additional Information:

Surgical management of adult spondylolysis and spondylolisthesis 

Publications:

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. Review.

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.

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.

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.

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.

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.

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.

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.

Hu SS, Tribus CB, Diab M, Ghanayem AJ. Spondylolisthesis and spondylolysis. J Bone Joint Surg Am. 2008 Mar;90(3):656-71. Review.

• Responsible Party: Fady Samy saeed, resident assiut university hospital, Assiut University
• ClinicalTrials.gov Identifier: NCT03877341
• Other Study ID Numbers: radiological plf vs plif
• First Posted: March 15, 2019
• Last Update Posted: March 15, 2019
• Last Verified: March 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No