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Completed

NCT Number: NCT03605797

Fixation of Sacral Fractures by Posterior Plate

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.

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Key information

Conditions

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut faculty of medicine

Asyut, 71111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

follow up of cases fixed by posterior tension band plate

Other

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Fixation of Sacral Fractures by Posterior Tension Band Plating

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 30, 2018
Registry last updated
May 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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