Sacral FractureNCT03605797
Fixation of Sacral Fractures by Posterior Plate
An observational study of Sacral Fracture, run by Assiut University at 1 site in Egypt.
Trial summary
The sacrum is the mechanical nucleus of the axial skeleton, serving as the base for the spinal column as well as the keystone for the pelvic ring. Sacral fractures occur in approximately 45% of all pelvic fractures. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Sacral Fracture
- What is being tested?
- follow up of cases fixed by posterior tension band plate
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2018to 1 May 2020
- Phase
- Observational
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: fixation of sacral fractures by posterior tenstion band plate then follow up of the functional outcome by majeed outcome score at 6th month post operative
Who may be able to join
- comminuted sacral fracture,
- bilateral sacral fracture,
- osteoporotic sacral fractures,
- spinopelvic dissociation and
- late presented (neglected) sacral fracture.
Who cannot join
- Patients with a preoperative diagnosis of a Morel- Lavallee lesion,
- unfit patients
- immature skeleton will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fixation of Sacral Fractures by Posterior Tension Band Plating
The sacrum is the mechanical nucleus of the axial skeleton, serving as the base for the spinal column as well as the keystone for the pelvic ring.
Sacral fractures occur in approximately 45% of all pelvic fractures. the mechanism of injury resulting in sacral fractures typically is one of high energy from motor vehicle accidents and fall from a height.
Approximately 30% of sacral fractures are identified late. Unrecognized and inadequately treated sacral fractures may lead to painful deformity and progressive loss of neurological function. Delayed surgery for posttraumatic sacral deformity is complex, and the results are often less favorable than those of early surgery. Therefore, determination of an integrated diagnostic and therapeutic approach to sacral fractures should be a goal.
Read the detailed description
Most sacral fractures can be treated non operatively. These include stable, non displaced sacral fractures without a significant associated pelvic ring disruption, fractures not involving the lumbosacral junction, and fractures without neurologic injury.
Surgical options range from minimally invasive techniques to formal open reduction and internal fixation. Techniques for neural decompression include laminotomy and foraminotomy, anterior bone disimpaction, and lumbosacral plexus neurolysis. Anterior sacral and pelvic stabilization techniques involve various methods of anterior stabilization of the pelvic ring (e.g., application of a sacroiliac plate). Posterior stabilization techniques include percutaneous sacroiliac screw fixation, bilateral sacroiliac screw fixation with posterior tension-band plate fixation, posterior alar plate fixation, and lumbopelvic segmental fixation.
Percutaneously placed iliosacral screws are commonly used for the fixation of sacroiliac joint disruptions and for sacral fractures. Adequate experience and intraoperative imaging is necessary to safely insert these screws, since the safe corridor for placement is fairly small. In some patients, such as those with a dysmorphic sacrum.
Transiliac posterior tension band fixation, offers an alternative method for stabilization of the posterior pelvic ring.
It is indicated in:vertically unstable comminuted sacral fractures, for which iliosacral screws may be insufficient. It is also indicated in patients with a dysmorphic sacrum in whom there is no safe corridor for placement of iliosacral screws. Threaded rods or a posterior plate may be secured to the posterior ilium.Also it can be used in bilateral sacral fracture; Late presented (neglected) sacral fractures and in osteoporotic sacral fracture.It is Minimally invasive technique with Less exposure to irradiation, image-independent, Easy, reproducible technique, Economic conventional implant and stable fixation.
- Conditions
- Sacral Fracture
- Being tested
- follow up of cases fixed by posterior tension band plate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follow up of cases fixed by posterior tension band plateOther
Follow up of the reduction and functional outcome evaluation using the Majeed functional outcome score
| Study group | Role | What they receive |
|---|---|---|
| No intervention | To study the indication and results of fixing the sacral fracture by tension band plating Receives: Other: follow up of cases fixed by posterior tension band plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Majeed functional outcome score
it is a pelvic injury-specific assessment divided into seven items such as pain, work, sitting, sexual intercourse, standing, gait unaided, and walking distance, with a total score range of 0-100 in order of decreasing disability.
Measured: 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start1 Jul 2018
- Primary completion6 Jan 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sacral 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahaaeldin Mohamed Abdelhafez, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605797
- Sponsor's protocol ID
- TBP
- Status last verified
- May 2020
- First submitted
- 11 Jul 2018
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Suzuki T, Hak DJ, Ziran BH, Adams SA, Stahel PF, Morgan SJ, Smith WR. Outcome and complications of posterior transiliac plating for vertically unstable sacral fractures. Injury. 2009 Apr;40(4):405-9. doi: 10.1016/j.injury.2008.06.039. Epub 2008 Dec 17.
PubMed 19095233Padalkar P, Pereira BP, Kathare A, Sun KK, Kagda F, Joseph T. Trans-iliosacral plating for vertically unstable fractures of sacral spine associated with spinopelvic dissociation: A cadaveric study. Indian J Orthop. 2012 May;46(3):274-8. doi: 10.4103/0019-5413.96376.
PubMed 22719112Sasso RC, Vaccaro AR, Chapman JR, Best NM, Zdeblick TA, Harris MB. Sacral fractures. Instr Course Lect. 2009;58:645-55.
PubMed 19385574
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fixation of Sacral Fractures by Posterior Tension Band Plating
- ClinicalTrials.gov ID
- NCT03605797
- Acronym / sponsor ID
- TBP
- Conditions
- Sacral Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 6 Jan 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 30 Jul 2018 (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 sacrum is the mechanical nucleus of the axial skeleton, serving as the base for the spinal column as well as the keystone for the pelvic ring.
Sacral fractures occur in approximately 45% of all pelvic fractures. the mechanism of injury resulting in sacral fractures typically is one of high energy from motor vehicle accidents and fall from a height.
Approximately 30% of sacral fractures are identified late. Unrecognized and inadequately treated sacral fractures may lead to painful deformity and progressive loss of neurological function. Delayed surgery for posttraumatic sacral deformity is complex, and the results are often less favorable than those of early surgery. Therefore, determination of an integrated diagnostic and therapeutic approach to sacral fractures should be a goal.
Detailed description
Most sacral fractures can be treated non operatively. These include stable, non displaced sacral fractures without a significant associated pelvic ring disruption, fractures not involving the lumbosacral junction, and fractures without neurologic injury.
Surgical options range from minimally invasive techniques to formal open reduction and internal fixation. Techniques for neural decompression include laminotomy and foraminotomy, anterior bone disimpaction, and lumbosacral plexus neurolysis. Anterior sacral and pelvic stabilization techniques involve various methods of anterior stabilization of the pelvic ring (e.g., application of a sacroiliac plate). Posterior stabilization techniques include percutaneous sacroiliac screw fixation, bilateral sacroiliac screw fixation with posterior tension-band plate fixation, posterior alar plate fixation, and lumbopelvic segmental fixation.
Percutaneously placed iliosacral screws are commonly used for the fixation of sacroiliac joint disruptions and for sacral fractures. Adequate experience and intraoperative imaging is necessary to safely insert these screws, since the safe corridor for placement is fairly small. In some patients, such as those with a dysmorphic sacrum.
Transiliac posterior tension band fixation, offers an alternative method for stabilization of the posterior pelvic ring.
It is indicated in:vertically unstable comminuted sacral fractures, for which iliosacral screws may be insufficient. It is also indicated in patients with a dysmorphic sacrum in whom there is no safe corridor for placement of iliosacral screws. Threaded rods or a posterior plate may be secured to the posterior ilium.Also it can be used in bilateral sacral fracture; Late presented (neglected) sacral fractures and in osteoporotic sacral fracture.It is Minimally invasive technique with Less exposure to irradiation, image-independent, Easy, reproducible technique, Economic conventional implant and stable fixation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No intervention | – | Other: follow up of cases fixed by posterior tension band plateTo study the indication and results of fixing the sacral fracture by tension band plating |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- fixation of sacral fractures by posterior tenstion band plate then follow up of the functional outcome by majeed outcome score at 6th month post operative
Key inclusion criteria (5 listed)
- comminuted sacral fracture,
- bilateral sacral fracture,
- osteoporotic sacral fractures,
- spinopelvic dissociation and
- late presented (neglected) sacral fracture.
Key exclusion criteria (3 listed)
- Patients with a preoperative diagnosis of a Morel- Lavallee lesion,
- unfit patients
- immature skeleton will be excluded
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 |
|---|---|---|
| follow up of cases fixed by posterior tension band plateFollow up of the reduction and functional outcome evaluation using the Majeed functional outcome score | Other | No intervention |
Primary outcome
Majeed functional outcome score
Time frame: 6th month
it is a pelvic injury-specific assessment divided into seven items such as pain, work, sitting, sexual intercourse, standing, gait unaided, and walking distance, with a total score range of 0-100 in order of decreasing disability.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Background: PubMed 19095233Suzuki T, Hak DJ, Ziran BH, Adams SA, Stahel PF, Morgan SJ, Smith WR. Outcome and complications of posterior transiliac plating for vertically unstable sacral fractures. Injury. 2009 Apr;40(4):405-9. doi: 10.1016/j.injury.2008.06.039. Epub 2008 Dec 17.
- Background: PubMed 22719112Padalkar P, Pereira BP, Kathare A, Sun KK, Kagda F, Joseph T. Trans-iliosacral plating for vertically unstable fractures of sacral spine associated with spinopelvic dissociation: A cadaveric study. Indian J Orthop. 2012 May;46(3):274-8. doi: 10.4103/0019-5413.96376.
- Background: PubMed 19385574Sasso RC, Vaccaro AR, Chapman JR, Best NM, Zdeblick TA, Harris MB. Sacral fractures. Instr Course Lect. 2009;58:645-55.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sacral Fracture, run by Assiut University at 1 site in Egypt.
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 5 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: finished, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Majeed functional outcome score (time frame: 6th month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03605797, which also lists 3 linked publications.
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 27 May 2020.