Minimally Invasive Surgical Management of Traumatic Spinopelvic Instability

April 1, 2022 updated by: Ahmed Abdelazim Abdelrahim Hassan, Assiut University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Study Procedure:

  1. 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.

  2. 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.

  3. 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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: minimally invasive spinopelvic fixation.

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.

  1. Inclusion criteria:

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

  2. Exclusion criteria:

    1. unwillingness to participate in the study
    2. pathological fractures
    3. other medical comorbidities that preclude surgical intervention.
Procedure: minimally invasive spinopelvic fixation

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Majeed pelvic score
Time Frame: it will be assessed at one and half month, three month, six month and one year after the surgery
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.
it will be assessed at one and half month, three month, six month and one year after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Form 12 (SF-12) score
Time Frame: it will be assessed at one and half month, three month, six month and one year after the surgery
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.
it will be assessed at one and half month, three month, six month and one year after the surgery
Oswestry disability index (ODI):
Time Frame: it will be assessed at one and half month, three month, six month and one year after the surgery
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.
it will be assessed at one and half month, three month, six month and one year after the surgery
Visual analogue scale of pain (VAS)
Time Frame: it will be assessed at one and half month, three month, six month and one year after the surgery
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.
it will be assessed at one and half month, three month, six month and one year after the surgery
AO PROST
Time Frame: it will be assessed at one and half month, three month, six month and one year after the surgery
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.
it will be assessed at one and half month, three month, six month and one year after the surgery
lumbar lordosis
Time Frame: it will be assessed at one and half month, three month, six month and one year after the surgery
it will measured in degrees on plain standing lateral lumbosacral x-rays.
it will be assessed at one and half month, three month, six month and one year after the surgery
Gibbons' criteria
Time Frame: it will be assessed at one and half month, three month, six month and one year after the surgery
it is a classification used to stratify patients with neurological deficit associated with pelvic injuries
it will be assessed at one and half month, three month, six month and one year after the surgery
pelvic incidence
Time Frame: it will be assessed at one and half month, three month, six month and one year after the surgery
it will be measured in degrees on plain standing lateral lumbosacral x-rays.
it will be assessed at one and half month, three month, six month and one year after the surgery
AP translation
Time Frame: it will be assessed at one and half month, three month, six month and one year after the surgery
it will be measured in millimetres on inlet and outlet pelvic x-rays.
it will be assessed at one and half month, three month, six month and one year after the surgery
vertical translation
Time Frame: it will be assessed at one and half month, three month, six month and one year after the surgery
it will be measured in millimetres on plain standing AP pelvic x-rays.
it will be assessed at one and half month, three month, six month and one year after the surgery
sacral table angle
Time Frame: it will be assessed at one and half month, three month, six month and one year after the surgery
it will be measured in degrees on plain standing lateral lumbosacral x-rays.
it will be assessed at one and half month, three month, six month and one year after the surgery
sacral kyphosis angle
Time Frame: it will be assessed at one and half month, three month, six month and one year after the surgery
it will be measured in degrees on plain standing lateral lumbosacral x-rays.
it will be assessed at one and half month, three month, six month and one year after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Ahmed A A Hassan, MBBCh, MSc, Assistant Lecturer, Faculty of Medicine, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

March 23, 2022

First Submitted That Met QC Criteria

April 1, 2022

First Posted (Actual)

April 11, 2022

Study Record Updates

Last Update Posted (Actual)

April 11, 2022

Last Update Submitted That Met QC Criteria

April 1, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Spinopelvic instability

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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