Minimally Invasive Surgical Management of Traumatic Spinopelvic Instability

NCT05321186 | Unknown

• 1 other identifier: Spinopelvic instability
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

SPINAL Fracture

Keywords

spinopelvic instability; spinoplevic dissociation; spinopelvic fixation; lumbopelvic fixation

Outcome Measures

Primary Outcomes (1)

• 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.

  it will be assessed at one and half month, three month, six month and one year after the surgery

Secondary Outcomes (11)

• Short Form 12 (SF-12) score

  it will be assessed at one and half month, three month, six month and one year after the surgery

• Oswestry disability index (ODI):

  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)

  it will be assessed at one and half month, three month, six month and one year after the surgery

• AO PROST

  it will be assessed at one and half month, three month, six month and one year after the surgery

• lumbar lordosis

  it will be assessed at one and half month, three month, six month and one year after the surgery

Study Arms (1)

minimally invasive spinopelvic fixation.

OTHER

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

Interventions

minimally invasive spinopelvic fixation 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.

minimally invasive spinopelvic fixation.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Spinal Fractures

Condition Hierarchy (Ancestors)

Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Ahmed A A Hassan, MBBCh, MSc

  Assistant Lecturer, Faculty of Medicine, Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed A A Hassan, MBBCh, MSc

CONTACT

+201288103657; ahmedabdelazim2014@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Orthopedics and Trauma Surgery

Model Details: the study will be a prospective interventional case series.

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 11, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share