Minimally Invasive Surgical Management of Traumatic Spinopelvic Instability

Not Applicable

• Conditions: SPINAL Fracture
• Interventions: Procedure: minimally invasive spinopelvic fixation

• Registration Number: NCT05321186
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2022-03-23
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-01
• Last Update Submitted: 2022-04-01
• Study First Posted: 2022-04-11
• Last Update Posted: 2022-04-11
• Study Start: 2022-06-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
minimally invasive spinopelvic fixation.	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.

Primary Outcome Measures

Name	Time	Method
Change in the Majeed pelvic score	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.

Secondary Outcome Measures

Name	Time	Method
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	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.
sacral kyphosis angle	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.
Oswestry disability index (ODI):	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.
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	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.
lumbar lordosis	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.
pelvic incidence	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.
sacral table angle	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.
Gibbons' criteria	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
AO PROST	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.
AP translation	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.
vertical translation	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.