Smiley Face Shaped Rod Technique Versus Instrumented Posteriolateral Fusion in Treatment of Isthmic Lumbar Spondylolisthesis
Primary Purpose
Isthmic Spondylolisthesis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
smiley face shape rod
Sponsored by
About this trial
This is an interventional treatment trial for Isthmic Spondylolisthesis
Eligibility Criteria
Inclusion Criteria:
- age above 18 years old
- Both sex
- failure of conservative treatment for 3months
- fit for surgery
Exclusion Criteria:
- age less than 18
- Not fit for surgery
- pathological fracture of pars
- assosciated pathology like disc degeneration, spinal canal stenosis, spondylolisthesis grad 2,3and 4
Sites / Locations
Outcomes
Primary Outcome Measures
change pain
assessment of pain change one week postoperation by using visual analog scale (AVS) and MacNabs chart to assess degree of change
radiological fusion of pars defect
using CT scan for fusion percentage assess at 6 month of postoperation.
Secondary Outcome Measures
Full Information
NCT ID
NCT04559399
First Posted
September 16, 2020
Last Updated
September 21, 2020
Sponsor
Assiut University
1. Study Identification
Unique Protocol Identification Number
NCT04559399
Brief Title
Smiley Face Shaped Rod Technique Versus Instrumented Posteriolateral Fusion in Treatment of Isthmic Lumbar Spondylolisthesis
Official Title
Smiley Face Shaped Rod Technique Versus Instrumented Posteriolateral Fusion in Treatment of Isthmic Lumbar Spondylolisthesis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Anticipated)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Aim of research is to investigates clinical, surgical and radiological outcome of vertebral pars intetarticularis repair by used smile face shape rod technique and bone grafting and comparing that with posteriolateral fusion with used traditional transpedical screw and rod fixation in management of isthmic spondylistheisis
Detailed Description
Isthmic spondylolisthesis is considered to represent a fatigue fracture of the pars interarticularis of the neural arch, The clinical symptom is activity-related back pain in young and athletic patients . The cause of Isthmic spondylolisthesis in these patients is repetitive stress of the pars interarticularis with subsequent microfracture, which in turn may lead to a bony defect and cause progressive spondylolisthesis in up to 25% of cases. Surgical intervention is indicated for patients who are not responsive despite adequate period of conservative management such as activity modification , physical therapy, and occasionally bracing .
Techniques for repair of a pars defect include Scott wiring , a Buck screw , a pedicle screw and hook , multiple segment fixations or a U-rod . After repair, radiographic healing rates range from 67 percent to 90 percent; asymptomatic and return to sports rates range from 80 percent to 90 percent.
These methods have achieved variable success .In Buck screw fusion surgery,it is not effect on flexion and axial rotation of the spine but bone healing is compromised.
Stabilization with wiring and titanium cable had less success rate than other methods and requires the use of lumbar brace or prolonged immobilization.
The pedicle screw-vertebral plate hook system may complicated by injury to the dural sac or nerves ensues.
Multiple segment fixation with pedicle screws and rods has good success of stabilization but it is effect on flexion and axial rotation of the spine, and may cause degenerative change in adjacent normal segments.
Smiley face shaped rod technique is new method used for repair of isthmic spodylolisthesis using pedical screw on effected segment and smiley face rod revolve around spinal process to stabilization of pars interarticularis of the same segment so it preserve axial rotation and flexion of spin also avoid degenerative change in adjacent levels.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Isthmic Spondylolisthesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
all patients confirmed diagnosis and including criteria of intervention divided randomly in to 2 groups,control group include patients treat by transpedical screw and rod fixation and experimental group include patients treats smiley face rod technique and then clinical and radiological follow up for 6 month.
the varibals that will be measure are:
intraoperative variables :length of wound,blood loss and time of operation.
clinical outcome:pain and disability
radiological variables :fusion and degenerative of the adjacent level
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
smiley face shape rod
Intervention Description
For treatment of isthmic spondylolithesis a transpedical screws for the same level and rod revolve around spinal process to stabilization of pars interarticularis of the same segment after removes bone at the margine of defects pars till reach to healthy bleed margine then put bone graft at the defect then stablizing pars and bone graft by rods.
Primary Outcome Measure Information:
Title
change pain
Description
assessment of pain change one week postoperation by using visual analog scale (AVS) and MacNabs chart to assess degree of change
Time Frame
pain assess one week postoperation
Title
radiological fusion of pars defect
Description
using CT scan for fusion percentage assess at 6 month of postoperation.
Time Frame
6 month postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age above 18 years old
Both sex
failure of conservative treatment for 3months
fit for surgery
Exclusion Criteria:
age less than 18
Not fit for surgery
pathological fracture of pars
assosciated pathology like disc degeneration, spinal canal stenosis, spondylolisthesis grad 2,3and 4
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Najib Al-shaea, MD
Phone
00201002784058
Email
nageebalshaya@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
mohammed Taghyan
Phone
00201006876892
Email
taghian@med.aun.edu.eg
12. IPD Sharing Statement
Citations:
PubMed Identifier
11131228
Citation
Standaert CJ, Herring SA. Spondylolysis: a critical review. Br J Sports Med. 2000 Dec;34(6):415-22. doi: 10.1136/bjsm.34.6.415.
Results Reference
background
PubMed Identifier
23737800
Citation
Widi GA, Williams SK, Levi AD. Minimally invasive direct repair of bilateral lumbar spine pars defects in athletes. Case Rep Med. 2013;2013:659078. doi: 10.1155/2013/659078. Epub 2013 Apr 30.
Results Reference
background
PubMed Identifier
12678361
Citation
Debnath UK, Freeman BJ, Gregory P, de la Harpe D, Kerslake RW, Webb JK. Clinical outcome and return to sport after the surgical treatment of spondylolysis in young athletes. J Bone Joint Surg Br. 2003 Mar;85(2):244-9. doi: 10.1302/0301-620x.85b2.13074.
Results Reference
background
PubMed Identifier
3180570
Citation
Bell DF, Ehrlich MG, Zaleske DJ. Brace treatment for symptomatic spondylolisthesis. Clin Orthop Relat Res. 1988 Nov;(236):192-8.
Results Reference
background
PubMed Identifier
2041003
Citation
Bonnici AV, Koka SR, Richards DJ. Results of Buck screw fusion in grade I spondylolisthesis. J R Soc Med. 1991 May;84(5):270-3. doi: 10.1177/014107689108400509.
Results Reference
background
PubMed Identifier
12974495
Citation
Herman MJ, Pizzutillo PD, Cavalier R. Spondylolysis and spondylolisthesis in the child and adolescent athlete. Orthop Clin North Am. 2003 Jul;34(3):461-7, vii. doi: 10.1016/s0030-5898(03)00034-8.
Results Reference
background
PubMed Identifier
23075858
Citation
Karatas AF, Dede O, Atanda AA, Holmes L Jr, Rogers K, Gabos P, Shah SA. Comparison of Direct Pars Repair Techniques of Spondylolysis in Pediatric and Adolescent Patients: Pars Compression Screw Versus Pedicle Screw-Rod-Hook. Clin Spine Surg. 2016 Aug;29(7):272-80. doi: 10.1097/BSD.0b013e318277cb7d.
Results Reference
background
PubMed Identifier
23691090
Citation
Chen XS, Zhou SY, Jia LS, Gu XM, Fang L, Zhu W. A universal pedicle screw and V-rod system for lumbar isthmic spondylolysis: a retrospective analysis of 21 cases. PLoS One. 2013 May 17;8(5):e63713. doi: 10.1371/journal.pone.0063713. Print 2013.
Results Reference
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Smiley Face Shaped Rod Technique Versus Instrumented Posteriolateral Fusion in Treatment of Isthmic Lumbar Spondylolisthesis
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