Sagittal Parameters After Mono Segmental Lumber Fusion: Interbody Versus Postrolateral Fusion
1 other identifier
interventional
42
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2019
Longer than P75 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
March 4, 2019
CompletedFirst Posted
Study publicly available on registry
March 15, 2019
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedSeptember 15, 2023
September 1, 2023
3.9 years
March 4, 2019
September 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
T1 pelvic angle
Pre op. Post op immediately. 6month post op
Pelvic incidence
Pre op. Post op immediately. 6month post op
Pelvic tilt
Pre op. Post op immediately. 6month post op
Sacral slope
Pre op. Post op immediately. 6month post op
Lumbar lordosis
Pre op. Post op immediately. 6month post op
Study Arms (2)
PLF
ACTIVE COMPARATORposterolateral fusion
PLIF
ACTIVE COMPARATORposterior lumbar interbody fusion
Interventions
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 (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.
Eligibility Criteria
You may qualify if:
- Adult patient older of 18 years old.
- Patients with lytic spondylolisthesis
- Low grade spondylolisthsis 1,2
You may not qualify if:
- Traumatic spondylolysis
- Previous spine surgery.
- Patient younger 18 years old
- High grade spondylolisthsis 3,4,5 - multiple levels spondylolithises
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut University Hospitals
Asyut, Egypt
Related Publications (9)
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.
PMID: 27683674BACKGROUNDMadan 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.
PMID: 12131714BACKGROUNDCLOWARD 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.
PMID: 13035484BACKGROUNDCole 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.
PMID: 19468868BACKGROUNDKuraishi 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.
PMID: 26949470BACKGROUNDHerkowitz 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.
PMID: 2071615BACKGROUNDFeffer 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.
PMID: 3992350BACKGROUNDLidar 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.
PMID: 16181997BACKGROUNDHu SS, Tribus CB, Diab M, Ghanayem AJ. Spondylolisthesis and spondylolysis. J Bone Joint Surg Am. 2008 Mar;90(3):656-71. No abstract available.
PMID: 18326106BACKGROUND
Study Officials
- STUDY DIRECTOR
mahmoud fouad, lecturer
assuit university hospitals
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 assiut university hospital
Study Record Dates
First Submitted
March 4, 2019
First Posted
March 15, 2019
Study Start
April 1, 2019
Primary Completion
March 1, 2023
Study Completion
March 1, 2023
Last Updated
September 15, 2023
Record last verified: 2023-09