Fixation of Sacral Fractures by Posterior Plate

Sacral Fracture Clinical Trial

Official title:

Fixation of Sacral Fractures by Posterior Tension Band Plating

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03605797
• Other study ID #: TBP
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: May 1, 2020

Study information

• Verified date: May 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 1, 2020
• Est. primary completion date: January 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Sacral Fracture

Intervention

Other:
• 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

Locations

Country	Name	City	State
Egypt	Assiut faculty of medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6th month