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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
Assiut University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Isthmic Spondylolisthesis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. age above 18 years old
  2. Both sex
  3. failure of conservative treatment for 3months
  4. fit for surgery

Exclusion Criteria:

  1. age less than 18
  2. Not fit for surgery
  3. pathological fracture of pars
  4. 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

    First Posted
    September 16, 2020
    Last Updated
    September 21, 2020
    Sponsor
    Assiut University
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    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
    background

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    Smiley Face Shaped Rod Technique Versus Instrumented Posteriolateral Fusion in Treatment of Isthmic Lumbar Spondylolisthesis

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