NCT03605797

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 30, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

1.5 years

First QC Date

July 11, 2018

Last Update Submit

May 23, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

No intervention

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

Other: follow up of cases fixed by posterior tension band plate

Interventions

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

No intervention

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

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

You may not qualify if:

  • Patients with a preoperative diagnosis of a Morel- Lavallee lesion,
  • unfit patients
  • immature skeleton will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut faculty of medicine

Asyut, 71111, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 19095233BACKGROUND
  • 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.

    PMID: 22719112BACKGROUND
  • Sasso RC, Vaccaro AR, Chapman JR, Best NM, Zdeblick TA, Harris MB. Sacral fractures. Instr Course Lect. 2009;58:645-55.

    PMID: 19385574BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 11, 2018

First Posted

July 30, 2018

Study Start

July 1, 2018

Primary Completion

January 6, 2020

Study Completion

May 1, 2020

Last Updated

May 27, 2020

Record last verified: 2020-05

Locations