Minimally Invasive Surgical Management of Traumatic Spinopelvic Instability

NCT ID: NCT05321186

Last Updated: 2022-04-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-06-01

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:

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.

Conditions

SPINAL Fracture

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

minimally invasive spinopelvic fixation

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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:

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abdelazim Abdelrahim Hassan

Assistant Lecturer of Orthopedics and Trauma Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed A A Hassan, MBBCh, MSc

Role: PRINCIPAL_INVESTIGATOR

Assistant Lecturer, Faculty of Medicine, Assiut University

Central Contacts

Ahmed A A Hassan, MBBCh, MSc

Role: CONTACT

ahmedabdelazim2014@yahoo.com

+201288103657

Other Identifiers

Spinopelvic instability

Identifier Type: -

Identifier Source: org_study_id