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Comparative Study Between Unillateral and Bilateral Lumbopelvic Fixation for Spinopelvic Dissociation

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ClinicalTrials.gov Identifier: NCT03515239
Recruitment Status : Not yet recruiting
First Posted : May 3, 2018
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Essam Kamal Rashid, Assiut University

Brief Summary:
Lumbopelvic fixation is the treatment opation for spinopelvic dissociation. In our study we will compare unilateral versus bilateral lumbopelvic fixation as regarding functional outcomes by Majeed score along a period of 12vmonths as a primary measure and metal failure,skin condition and nonunion as secondaries.

Condition or disease Intervention/treatment
Lumbosacral Instability Procedure: lumbopelvic fixation for spinopelvic dissociation

Detailed Description:

Traumatic loss of connection between the spine and pelvis can adopt many forms including lumbosacral fracture dislocation and bilateral sacroiliac dislocation. However, the term spinopelvic dissociation refers to a pathological condition in which this dissociation occurs due to the association of a transverse fracture with sagittal fractures in both sacral wings, result-ing in a proximal segment with the vertebral spine and the proximal sacral fragment, which is mechanically separated from a distal segment formed by the pelvic girdle and the rest of the sacrum.

Spinopelvic dissociation is an important entity to recognize because these fractures are almost uniformly unstable with a very narrow set of criteria for conservative management .

The mechanism of injury includes a very high energy trauma with axial compression on the sacrum.

Various options for internal fixation have been proposed, including percutaneous iliosacral screws, transiliac bars, sacral rods, posterior small plates, or vertical stabilization alone .

Some authors have introduced the technique of triangular posterior osteosynthesis (TPO) in the treatment of vertically unstable pelvic fracture..This is a biplanar fixation able to counterbalance the forces on the posterior pelvic ring during unipodal stance, so as to allow early weight-bearing. The stability of fixation could be confirmed by biomechanical testing of human specimens with transforaminal sacral fractures submitted to cyclic loading. The load to failure of the commonly used internal fixation techniques (sacroiliac screw fixation, plating limited to the sacrum) amounted to 60% of the load to failure of triangular stabilizations. In order to perform the triangular osteosynthesis, we used the Click'X system (Synthes, Oberdorf, Switzerland). Pedicle screws were first inserted in the pedicle of L4. Subsequently caudal screws were implanted into the iliac bone, through the posterior-superior-iliac-spine and parallel to the sacroiliac joint. Once the four screws were inserted, reduction was carried out. Connecting rods were inserted and tightened initially only over the proximal pedicle screws of L4.

The pedicle screws were used as ''joysticks'' in order to achieve reduction in the vertical and horizontal direction at this point, the connecting rod was tightened over the distal screws, therefore stabilizing the fracture. In order to obtain stabilization in the horizontal plane a 6-mm rod was inserted as atransversal cross-link between the two longitudinal connecting rods.e used the Click'X system (Synthes, Oberdorf, Switzerland). Pedicle screws were first inserted in the pedicle of L4. Subsequently caudal screws were implanted into the iliac bone, through the posterior-superior-iliac-spine and parallel to the sacroiliac joint. Once the four screws were inserted, reduction was carried out. Connecting rods were inserted and tightened initially only over the proximal pedicle screws of L4.

The pedicle screws were used as ''joysticks'' in order to achieve reduction in the vertical and horizontal direction at this point, the connecting rod was tightened over the distal screws, therefore stabilizing the fracture. In order to obtain stabilization in the horizontal plane a 6-mm rod was inserted as a transversal cross-link between the two longitudinal connecting rods.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparative Study Between Unillateral and Bilateral Lumbopelvic Fixation for Spinopelvic Dissociation
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: lumbopelvic fixation for spinopelvic dissociation
    unilateral and bilateral lumbopelvic fixation for spinopelvic dissociation


Primary Outcome Measures :
  1. Functional outcomes by Majeed score [ Time Frame: Along a period of 12 monthes. ]
    Functional outcomes by Majeed score in group of patient with spinopelvic dissociation fixed by unilateral triangular osteosynthesis and comparing them with group of patient fixed by bilateral triangular osteosynthesis.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Skeletally mature and neurologically free patient
Criteria

Inclusion Criteria:

  • injury severity score <22
  • neurologically free patient

Exclusion Criteria:

  • injury severity score >22
  • patient with neurological injury

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515239


Contacts
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Contact: Essam Kamal, resident 01002190495 esamelbadry13@gmail.com
Contact: Mahmoud Badran, lectature

Sponsors and Collaborators
Assiut University

Publications:
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Responsible Party: Essam Kamal Rashid, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03515239    
Other Study ID Numbers: spinopelvic dissociation
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dissociative Disorders
Mental Disorders