Open Reduction Internal Versus Percutaneous Sacroiliac Screw Fixation in Unstable Posterior Ring Injury of Pelvic

Sponsor

Ataturk University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05473611

Collaborator

(none)

Enrollment

Location

12.1

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Orthopedic Disorder	Procedure: closed reduction percutaneous fixation with open reduction internal fixation of the posterior pelvic ring

Detailed Description

Pelvic injuries are usually encountered in patients with polytrauma. These are injuries that need to be treated with a multidisciplinary approach. The primary approach is to stabilize the patient hemodynamically. Mortality rate in pelvic injuries reaches 10-20%.

The pelvis has a ring-shaped structure. It is the sacrum that transfers the load from the lower extremities to the axial spine from this structure. The joint between the sacrum and the ilium, that is, the joint that is exposed to the load, is the sacroiliac joint. For this reason, surgical treatments have been developed to stabilize the posterior pelvic ring, to mobilize the patient as soon as possible, to walk in a balanced way without leg length difference, to prevent loss of work force, and to shorten the hospitalization period. Open reduction internal fixation and closed reduction percutaneous sacroiliac screw fixation surgical methods have been described to ensure the stability of the posterior pelvic ring In this study, we evaluated the radiological and functional results of patients with posterior pelvic ring injuries stabilized by open and closed surgical approaches; We have compiled and summarized the current literature on pelvic injuries. We aimed to contribute to the literature by sharing our knowledge and findings about these difficult, complex and prone surgical techniques.

marks of conformity

Surgical intervention for sacroiliac joint fracture-dislocation
18-65 years old patient
Patients who come to clinical follow-ups for at least 6 months

Study Design

Study Type:

Observational

Anticipated Enrollment :

90 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

Comparison of Open Reduction Internal Fixation and Percutaneous Sacroiliac Screw Fixation in Unstable Posterior Ring Injury of The Pelvic

Actual Study Start Date :

Mar 10, 2022

Anticipated Primary Completion Date :

Nov 10, 2022

Anticipated Study Completion Date :

Mar 12, 2023

Arms and Interventions

Arm	Intervention/Treatment
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 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 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 closed reduction percutaneous fixation with open reduction internal fixation of the posterior pelvic ring

Arm

Intervention/Treatment

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

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

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

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

Outcome Measures

Primary Outcome Measures

functional scoring [at least 6 months]
Grading of outcomes using the clinical functional scoring system for pelvic injuries defined by Majeed
radiological scoring [at least 6 months]
Radiological grading of the treatment process of pelvic fracture with the measurement methods of pelvic plain radiographs defined by Matta and Henderson

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Surgical intervention for sacroiliac joint fracture-dislocation
18-65 years old patient
Patients who come to clinical follow-ups for at least six months
not paralyzed

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ataturk University Faculty of Medicine	Erzurum	Yakutiye	Turkey	25050

Sponsors and Collaborators

Ataturk University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mehmet Koçaslan, Principal investigator, Ataturk University

ClinicalTrials.gov Identifier:

NCT05473611

Other Study ID Numbers:

Ataturk University Orthopedic

First Posted:

Jul 26, 2022

Last Update Posted:

Aug 5, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mehmet Koçaslan, Principal investigator, Ataturk University

instabil pelvic injury, percutaneus sacroiliac screw

Additional relevant MeSH terms:

Musculoskeletal Diseases

Study Results

No Results Posted as of Aug 5, 2022