NCT05473611

Brief Summary

Surgical trearment of unstable posterior pelvic injuries can be performed with open reduction and internal fixation, closed reduction with percutaneous sacroiliac fixation. Biomechanically, no significant difference was found between the two methods in the literature. The aim of our study is to compare the radiological and clinical functional results of these methods.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2023

Completed
Last Updated

August 5, 2022

Status Verified

August 1, 2022

Enrollment Period

8 months

First QC Date

July 22, 2022

Last Update Submit

August 3, 2022

Conditions

Keywords

instabil pelvic injury, percutaneus sacroiliac screw

Outcome Measures

Primary Outcomes (2)

  • functional scoring

    Grading of outcomes using the clinical functional scoring system for pelvic injuries defined by Majeed

    at least 6 months

  • radiological scoring

    Radiological grading of the treatment process of pelvic fracture with the measurement methods of pelvic plain radiographs defined by Matta and Henderson

    at least 6 months

Study Arms (3)

closed reduction percutaneous fixation method

Patients with closed reduction percutaneous sacroiliac screw fixation of posterior pelvic ring due to unstable pelvic injury

Procedure: closed reduction percutaneous fixation with open reduction internal fixation of the posterior pelvic ring

open reduction anterior sacroiliac approach

Patients with fixation of the posterior pelvic ring by open reduction anterior approach due to unstable pelvic injury

Procedure: closed reduction percutaneous fixation with open reduction internal fixation of the posterior pelvic ring

open reduction posterior sacroiliac approach

Patients with fixation of the posterior pelvic ring by open reduction posterior approach due to unstable pelvic injury

Procedure: closed reduction percutaneous fixation with open reduction internal fixation of the posterior pelvic ring

Interventions

closed reduction percutaneous fixation with open reduction internal fixation of the posterior pelvic ring

closed reduction percutaneous fixation methodopen reduction anterior sacroiliac approachopen reduction posterior sacroiliac approach

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged 18-65 years who suffered pelvic injury admitted to Atatürk University Research Hospital

You may qualify if:

  • Surgical intervention for sacroiliac joint fracture-dislocation
  • years old patient
  • Patients who come to clinical follow-ups for at least six months
  • not paralyzed

You may not qualify if:

  • Patients under 18 years of age
  • Patients older than 65 years
  • Patients who did not come for their follow-up in our clinic
  • paralyzed patients
  • mentally retarded patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University Faculty of Medicine

Erzurum, Yakutiye, 25050, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 22, 2022

First Posted

July 26, 2022

Study Start

March 10, 2022

Primary Completion

November 10, 2022

Study Completion

March 12, 2023

Last Updated

August 5, 2022

Record last verified: 2022-08

Locations