Clinical trial NCT05321186: Minimally Invasive Surgical Management of Traumatic Spinopelvic Instability
Official title: Minimally Invasive Surgical Management of Traumatic Spinopelvic Instability
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: SPINAL Fracture
Keywords: spinopelvic instability
spinoplevic dissociation
spinopelvic fixation
lumbopelvic fixation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: the study will be a prospective interventional case series.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in the Majeed pelvic score
timeFrame: it will be assessed at one and half month, three month, six month and one year after the surgery
Secondary outcomes:
measure: Short Form 12 (SF-12) score
timeFrame: it will be assessed at one and half month, three month, six month and one year after the surgery
measure: Oswestry disability index (ODI):
timeFrame: it will be assessed at one and half month, three month, six month and one year after the surgery
measure: Visual analogue scale of pain (VAS)
timeFrame: it will be assessed at one and half month, three month, six month and one year after the surgery
measure: AO PROST
timeFrame: it will be assessed at one and half month, three month, six month and one year after the surgery
measure: lumbar lordosis
timeFrame: it will be assessed at one and half month, three month, six month and one year after the surgery
measure: Gibbons' criteria
timeFrame: it will be assessed at one and half month, three month, six month and one year after the surgery
measure: pelvic incidence
timeFrame: it will be assessed at one and half month, three month, six month and one year after the surgery
measure: AP translation
timeFrame: it will be assessed at one and half month, three month, six month and one year after the surgery
measure: vertical translation
timeFrame: it will be assessed at one and half month, three month, six month and one year after the surgery
measure: sacral table angle
timeFrame: it will be assessed at one and half month, three month, six month and one year after the surgery
measure: sacral kyphosis angle
timeFrame: it will be assessed at one and half month, three month, six month and one year after the surgery
Other outcomes:
Locations:
Study officials:
affiliation: Assistant Lecturer, Faculty of Medicine, Assiut University
name: Ahmed A A Hassan, MBBCh, MSc
role: PRINCIPAL_INVESTIGATOR
References: