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Minimally Invasive Surgical Management of Traumatic Spinopelvic Instability

Primary Purpose

SPINAL Fracture

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
minimally invasive spinopelvic fixation
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SPINAL Fracture focused on measuring spinopelvic instability, spinoplevic dissociation, spinopelvic fixation, lumbopelvic fixation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Skeletally mature patients presenting with sacral fractures (provided that the fracture line passes below the level of S2) associated with lumbosacral instability showing one of the following:

  1. Unilateral or bilateral L5-S1 facet fractures (AO classification type C1 and C2)
  2. Spinopelvic dissociation (AO type C3)
  3. Traumatic lumbosacral dislocation

Exclusion Criteria:

  1. unwillingness to participate in the study
  2. pathological fractures
  3. other medical comorbidities that preclude surgical intervention.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    minimally invasive spinopelvic fixation.

    Arm Description

    the arm will include skeletally mature patients (between the age of 18-60) presenting with sacral fractures (provided that the fracture line passes below the level of S2) associated with lumbosacral instability) with the following inclusion and exclusion criteria. Inclusion criteria: Unilateral or bilateral L5-S1 facet fractures (AO classification type C1 and C2) Spinopelvic dissociation (AO type C3) Traumatic lumbosacral dislocation Exclusion criteria: unwillingness to participate in the study pathological fractures other medical comorbidities that preclude surgical intervention.

    Outcomes

    Primary Outcome Measures

    Change in the Majeed pelvic score
    it is a patient reported outcome score used for functional assessment after pelvic fractures.The score ranges from 0 to 100 with 0 representing the most disability and 100 the best function.

    Secondary Outcome Measures

    Short Form 12 (SF-12) score
    it is a 12-item, patient-reported survey of patient health.The score ranges from 0 to 100, with higher scores indicating better physical and mental health functioning.
    Oswestry disability index (ODI):
    it is a Patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain.
    Visual analogue scale of pain (VAS)
    It is a patient reported tool for assessment of pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain.
    AO PROST
    it is a specific patient reported outcome score designed for spine trauma patients.It consists of 19 questions on a broad range of aspects of functioning on a 0-100 numeric rating scale with 0 indicating no function at all and 100 the pre-injury level of function.
    lumbar lordosis
    it will measured in degrees on plain standing lateral lumbosacral x-rays.
    Gibbons' criteria
    it is a classification used to stratify patients with neurological deficit associated with pelvic injuries
    pelvic incidence
    it will be measured in degrees on plain standing lateral lumbosacral x-rays.
    AP translation
    it will be measured in millimetres on inlet and outlet pelvic x-rays.
    vertical translation
    it will be measured in millimetres on plain standing AP pelvic x-rays.
    sacral table angle
    it will be measured in degrees on plain standing lateral lumbosacral x-rays.
    sacral kyphosis angle
    it will be measured in degrees on plain standing lateral lumbosacral x-rays.

    Full Information

    First Posted
    March 23, 2022
    Last Updated
    April 1, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05321186
    Brief Title
    Minimally Invasive Surgical Management of Traumatic Spinopelvic Instability
    Official Title
    Minimally Invasive Surgical Management of Traumatic Spinopelvic Instability
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2022 (Anticipated)
    Primary Completion Date
    June 1, 2023 (Anticipated)
    Study Completion Date
    June 1, 2023 (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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    the main aim of this study is to evaluate the results of performing minimally invasive surgical management for cases with traumatic spinopelvic instability and spinopelvic dissociation. This will include using percutaneous pedicle and S2 alar iliac screws, minimally invasive transforaminal lumbar interbody fusion and transtubular posterior decompression.
    Detailed Description
    Study Procedure: Patient enrollment and pre-operative evaluation: Upon Arrival, the patient will be managed in the emergency department according to the Advanced Trauma Life Support (ATLS) protocol. After achieving the haemodynamic stability, in cases of shock, X-rays (AP and lateral view of the lumbosacral region, inlet and outlet views of the pelvis) and CT scan of the pelvis will be performed. If the fracture pattern fits the inclusion criteria, the patient will be offered to enroll in the study and the patient will be prepared for surgery. Surgery: The surgery will be performed under general anaesthesia and fluoroscopic guidance. The patients will be positioned prone on an open top of a radiolucent table with large bumps under the thighs to accentuate an extension force on the legs which will be the main reduction maneuver in the surgical procedure. Bilateral percutaneous L4 and L5 pedicle screws will be placed under fluoroscopic guidance with Jamshidi needles, and these were will also be used the iliac fixation via percutaneous S2 alar iliac screws. Cases presenting with significant instability, minimally invasive Transforaminal lumbar interbody fusion (MIS-TLIF) will be performed. Additionally, in cases with neurological deficit, posterior decompression will be performed. Follow-up The patient will have four follow up visits (one and half month, 3month, 6month and 1 year) besides the discharge visit, during which the functional outcome scores will be filled out. AP and lateral view pelvis x-rays will be performed every visit. CT scan, AP and lateral scanograms will be only performed on the 1-year visit.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    SPINAL Fracture
    Keywords
    spinopelvic instability, spinoplevic dissociation, spinopelvic fixation, lumbopelvic fixation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    the study will be a prospective interventional case series.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    minimally invasive spinopelvic fixation.
    Arm Type
    Other
    Arm Description
    the arm will include skeletally mature patients (between the age of 18-60) presenting with sacral fractures (provided that the fracture line passes below the level of S2) associated with lumbosacral instability) with the following inclusion and exclusion criteria. Inclusion criteria: Unilateral or bilateral L5-S1 facet fractures (AO classification type C1 and C2) Spinopelvic dissociation (AO type C3) Traumatic lumbosacral dislocation Exclusion criteria: unwillingness to participate in the study pathological fractures other medical comorbidities that preclude surgical intervention.
    Intervention Type
    Procedure
    Intervention Name(s)
    minimally invasive spinopelvic fixation
    Intervention Description
    Bilateral percutaneous L4 and L5 pedicle screws will be placed under fluoroscopic guidance with Jamshidi needles, and these were will also be used the iliac fixation via percutaneous S2 alar iliac screws. Cases presenting with significant instability, minimally invasive Transforaminal lumbar interbody fusion (MIS-TLIF) will be performed. Additionally, in cases with neurological deficit, posterior decompression will be performed.
    Primary Outcome Measure Information:
    Title
    Change in the Majeed pelvic score
    Description
    it is a patient reported outcome score used for functional assessment after pelvic fractures.The score ranges from 0 to 100 with 0 representing the most disability and 100 the best function.
    Time Frame
    it will be assessed at one and half month, three month, six month and one year after the surgery
    Secondary Outcome Measure Information:
    Title
    Short Form 12 (SF-12) score
    Description
    it is a 12-item, patient-reported survey of patient health.The score ranges from 0 to 100, with higher scores indicating better physical and mental health functioning.
    Time Frame
    it will be assessed at one and half month, three month, six month and one year after the surgery
    Title
    Oswestry disability index (ODI):
    Description
    it is a Patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain.
    Time Frame
    it will be assessed at one and half month, three month, six month and one year after the surgery
    Title
    Visual analogue scale of pain (VAS)
    Description
    It is a patient reported tool for assessment of pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain.
    Time Frame
    it will be assessed at one and half month, three month, six month and one year after the surgery
    Title
    AO PROST
    Description
    it is a specific patient reported outcome score designed for spine trauma patients.It consists of 19 questions on a broad range of aspects of functioning on a 0-100 numeric rating scale with 0 indicating no function at all and 100 the pre-injury level of function.
    Time Frame
    it will be assessed at one and half month, three month, six month and one year after the surgery
    Title
    lumbar lordosis
    Description
    it will measured in degrees on plain standing lateral lumbosacral x-rays.
    Time Frame
    it will be assessed at one and half month, three month, six month and one year after the surgery
    Title
    Gibbons' criteria
    Description
    it is a classification used to stratify patients with neurological deficit associated with pelvic injuries
    Time Frame
    it will be assessed at one and half month, three month, six month and one year after the surgery
    Title
    pelvic incidence
    Description
    it will be measured in degrees on plain standing lateral lumbosacral x-rays.
    Time Frame
    it will be assessed at one and half month, three month, six month and one year after the surgery
    Title
    AP translation
    Description
    it will be measured in millimetres on inlet and outlet pelvic x-rays.
    Time Frame
    it will be assessed at one and half month, three month, six month and one year after the surgery
    Title
    vertical translation
    Description
    it will be measured in millimetres on plain standing AP pelvic x-rays.
    Time Frame
    it will be assessed at one and half month, three month, six month and one year after the surgery
    Title
    sacral table angle
    Description
    it will be measured in degrees on plain standing lateral lumbosacral x-rays.
    Time Frame
    it will be assessed at one and half month, three month, six month and one year after the surgery
    Title
    sacral kyphosis angle
    Description
    it will be measured in degrees on plain standing lateral lumbosacral x-rays.
    Time Frame
    it will be assessed at one and half month, three month, six month and one year after the surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Skeletally mature patients presenting with sacral fractures (provided that the fracture line passes below the level of S2) associated with lumbosacral instability showing one of the following: Unilateral or bilateral L5-S1 facet fractures (AO classification type C1 and C2) Spinopelvic dissociation (AO type C3) Traumatic lumbosacral dislocation Exclusion Criteria: unwillingness to participate in the study pathological fractures other medical comorbidities that preclude surgical intervention.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed A A Hassan, MBBCh, MSc
    Phone
    +201288103657
    Email
    ahmedabdelazim2014@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ahmed A A Hassan, MBBCh, MSc
    Organizational Affiliation
    Assistant Lecturer, Faculty of Medicine, Assiut University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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