SPINAL Fracture
Conditions
Keywords
spinopelvic instability, spinoplevic dissociation, spinopelvic fixation, lumbopelvic fixation
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.
Interventions
PROCEDUREminimally 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.
Sponsors
Assiut University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
the study will be a prospective interventional case series.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Contacts
Primary ContactAhmed A A Hassan, MBBCh, MSc
Outcome results
None listed