NCT03515239

Brief Summary

Lumbopelvic fixation is the treatment opation for spinopelvic dissociation. In our study we will compare unilateral versus bilateral lumbopelvic fixation as regarding functional outcomes by Majeed score along a period of 12vmonths as a primary measure and metal failure,skin condition and nonunion as secondaries.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2019

Status
unknown

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

First Submitted

Initial submission to the registry

April 16, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 3, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

March 7, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

April 16, 2018

Last Update Submit

March 5, 2019

Conditions

Lumbosacral Instability

Outcome Measures

Primary Outcomes (1)

  • Functional outcomes by Majeed score

    Functional outcomes by Majeed score in group of patient with spinopelvic dissociation fixed by unilateral triangular osteosynthesis and comparing them with group of patient fixed by bilateral triangular osteosynthesis.

    Along a period of 12 monthes.

Interventions

lumbopelvic fixation for spinopelvic dissociationPROCEDURE

unilateral and bilateral lumbopelvic fixation for spinopelvic dissociation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Skeletally mature and neurologically free patient

You may qualify if:

  • injury severity score \<22
  • neurologically free patient

You may not qualify if:

  • injury severity score \>22
  • patient with neurological injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Denis F, Davis S, Comfort T. Sacral fractures: an important problem. Retrospective analysis of 236 cases. Clin Orthop Relat Res. 1988 Feb;227:67-81.

    PMID: 3338224BACKGROUND

  • Roy-Camille R, Saillant G, Gagna G, Mazel C. Transverse fracture of the upper sacrum. Suicidal jumper's fracture. Spine (Phila Pa 1976). 1985 Nov;10(9):838-45. doi: 10.1097/00007632-198511000-00011.

    PMID: 4089659BACKGROUND

  • Gibbons KJ, Soloniuk DS, Razack N. Neurological injury and patterns of sacral fractures. J Neurosurg. 1990 Jun;72(6):889-93. doi: 10.3171/jns.1990.72.6.0889.

    PMID: 2338573BACKGROUND

Central Study Contacts

Essam Kamal, resident

CONTACT

01002190495esamelbadry13@gmail.com

Mahmoud Badran, lectature

CONTACT

Study Design

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

Study Record Dates

First Submitted

April 16, 2018

First Posted

May 3, 2018

Study Start

June 1, 2019

Primary Completion

June 1, 2020

Study Completion

July 1, 2020

Last Updated

March 7, 2019

Record last verified: 2019-03