Minimally Invasive Surgical Management of Traumatic Spinopelvic Instability

SPINAL Fracture Clinical Trial

Official title:

Minimally Invasive Surgical Management of Traumatic Spinopelvic Instability

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05321186
• Other study ID #: Spinopelvic instability
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: April 2022
• Source: Assiut University
• Contact: Ahmed A A Hassan, MBBCh, MSc
• Phone: +201288103657
• Email: ahmedabdelazim2014[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• SPINAL Fracture
• Spinal Fractures

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Short Form 12 (SF-12) score	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
Secondary	Oswestry disability index (ODI):	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
Secondary	Visual analogue scale of pain (VAS)	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
Secondary	AO PROST	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
Secondary	lumbar lordosis	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
Secondary	Gibbons' criteria	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
Secondary	pelvic incidence	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
Secondary	AP translation	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
Secondary	vertical translation	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
Secondary	sacral table angle	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
Secondary	sacral kyphosis angle	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