Fixation of Sacral Fractures by Posterior Plate

NCT ID: NCT03605797

Last Updated: 2020-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2020-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Sacral Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

No intervention

To study the indication and results of fixing the sacral fracture by tension band plating

follow up of cases fixed by posterior tension band plate

Intervention Type OTHER

Follow up of the reduction and functional outcome evaluation using the Majeed functional outcome score

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

follow up of cases fixed by posterior tension band plate

Follow up of the reduction and functional outcome evaluation using the Majeed functional outcome score

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* comminuted sacral fracture,
* bilateral sacral fracture,
* osteoporotic sacral fractures,
* spinopelvic dissociation and
* late presented (neglected) sacral fracture.

Exclusion Criteria

* Patients with a preoperative diagnosis of a Morel- Lavallee lesion,
* unfit patients
* immature skeleton will be excluded
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Bahaaeldin Mohamed Abdelhafez

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Assiut faculty of medicine

Asyut, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 19095233 (View on PubMed)

Padalkar 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.

Reference Type BACKGROUND
PMID: 22719112 (View on PubMed)

Sasso RC, Vaccaro AR, Chapman JR, Best NM, Zdeblick TA, Harris MB. Sacral fractures. Instr Course Lect. 2009;58:645-55.

Reference Type BACKGROUND
PMID: 19385574 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TBP

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.