SPINAL FractureNCT05321186
Minimally Invasive Surgical Management of Traumatic Spinopelvic Instability
A study testing minimally invasive spinopelvic fixation in people with SPINAL Fracture, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- SPINAL Fracture
- What is being tested?
- minimally invasive spinopelvic fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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:
- Unilateral or bilateral L5-S1 facet fractures (AO classification type C1 and C2)
- Spinopelvic dissociation (AO type C3)
- Traumatic lumbosacral dislocation
Who cannot join
- unwillingness to participate in the study
- pathological fractures
- other medical comorbidities that preclude surgical intervention.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
Study Procedure:
- 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.
- 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.
- 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
- Being tested
- minimally invasive spinopelvic fixation
- Keywords
- spinopelvic instability, spinoplevic dissociation, spinopelvic fixation, lumbopelvic fixation
- Medical subject headings
- Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimally invasive spinopelvic fixationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| minimally invasive spinopelvic fixation. | Other | 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. Receives: Procedure: minimally invasive spinopelvic fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: it will be assessed at one and half month, three month, six month and one year after the surgery
Secondary outcomes (11)
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.
Measured: it will be assessed at one and half month, three month, six month and one year after the surgery
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.
Measured: it will be assessed at one and half month, three month, six month and one year after the surgery
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.
Measured: it will be assessed at one and half month, three month, six month and one year after the surgery
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.
Measured: it will be assessed at one and half month, three month, six month and one year after the surgery
lumbar lordosis
it will measured in degrees on plain standing lateral lumbosacral x-rays.
Measured: it will be assessed at one and half month, three month, six month and one year after the surgery
Gibbons' criteria
it is a classification used to stratify patients with neurological deficit associated with pelvic injuries
Measured: it will be assessed at one and half month, three month, six month and one year after the surgery
pelvic incidence
it will be measured in degrees on plain standing lateral lumbosacral x-rays.
Measured: it will be assessed at one and half month, three month, six month and one year after the surgery
AP translation
it will be measured in millimetres on inlet and outlet pelvic x-rays.
Measured: it will be assessed at one and half month, three month, six month and one year after the surgery
vertical translation
it will be measured in millimetres on plain standing AP pelvic x-rays.
Measured: it will be assessed at one and half month, three month, six month and one year after the surgery
sacral table angle
it will be measured in degrees on plain standing lateral lumbosacral x-rays.
Measured: it will be assessed at one and half month, three month, six month and one year after the surgery
sacral kyphosis angle
it will be measured in degrees on plain standing lateral lumbosacral x-rays.
Measured: it will be assessed at one and half month, three month, six month and one year after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SPINAL FractureStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- the study will be a prospective interventional case series.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelazim Abdelrahim Hassan, Assiut University
- Investigators
- Ahmed A A Hassan, MBBCh, MSc, Principal investigator, Assistant Lecturer, Faculty of Medicine, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321186
- Sponsor's protocol ID
- Spinopelvic instability
- Status last verified
- Apr 2022
- First submitted
- 23 Mar 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Surgical Management of Traumatic Spinopelvic Instability
- ClinicalTrials.gov ID
- NCT05321186
- Acronym / sponsor ID
- Spinopelvic instability
- Conditions
- SPINAL Fracture
- Keywords
- spinopelvic instability, spinoplevic dissociation, spinopelvic fixation, lumbopelvic fixation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- the study will be a prospective interventional case series.
| Arm | Type | Receives |
|---|---|---|
| minimally invasive spinopelvic fixation. | Other | Procedure: minimally invasive spinopelvic fixationthe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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:
- Unilateral or bilateral L5-S1 facet fractures (AO classification type C1 and C2)
- Spinopelvic dissociation (AO type C3)
- Traumatic lumbosacral dislocation
Key exclusion criteria (3 listed)
- unwillingness to participate in the study
- pathological fractures
- other medical comorbidities that preclude surgical intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| minimally invasive spinopelvic fixationBilateral 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. | Procedure or surgery | minimally invasive spinopelvic fixation. |
Primary outcome
Change in the Majeed pelvic score
Time frame: 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.
11 secondary outcomes
Short Form 12 (SF-12) score
Time frame: it will be assessed at one and half month, three month, six month and one year after the surgery
Oswestry disability index (ODI):
Time frame: it will be assessed at one and half month, three month, six month and one year after the surgery
Visual analogue scale of pain (VAS)
Time frame: it will be assessed at one and half month, three month, six month and one year after the surgery
AO PROST
Time frame: it will be assessed at one and half month, three month, six month and one year after the surgery
lumbar lordosis
Time frame: it will be assessed at one and half month, three month, six month and one year after the surgery
Gibbons' criteria
Time frame: it will be assessed at one and half month, three month, six month and one year after the surgery
pelvic incidence
Time frame: it will be assessed at one and half month, three month, six month and one year after the surgery
AP translation
Time frame: it will be assessed at one and half month, three month, six month and one year after the surgery
vertical translation
Time frame: it will be assessed at one and half month, three month, six month and one year after the surgery
sacral table angle
Time frame: it will be assessed at one and half month, three month, six month and one year after the surgery
sacral kyphosis angle
Time frame: it will be assessed at one and half month, three month, six month and one year after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed A A Hassan, MBBCh, MSc principal investigator
Assistant Lecturer, Faculty of Medicine, Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing minimally invasive spinopelvic fixation in people with SPINAL Fracture, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A A Hassan, MBBCh, MSc (+201288103657, ahmedabdelazim2014@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Majeed pelvic score (time frame: it will be assessed at one and half month, three month, six month and one year after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.