- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05473611
Open Reduction Internal Versus Percutaneous Sacroiliac Screw Fixation in Unstable Posterior Ring Injury of Pelvic
Comparison of Open Reduction Internal Fixation and Percutaneous Sacroiliac Screw Fixation in Unstable Posterior Ring Injury of The Pelvic
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Ali Aydin
- Phone Number: +905386802430
- Email: draliaydin@hotmail.com
Study Locations
-
-
Yakutiye
-
Erzurum, Yakutiye, Turkey, 25050
- Recruiting
- Atatürk University Faculty of Medicine
-
Contact:
- Ataturk University Faculty of Medicine, doctorate
- Phone Number: 905324556473
- Email: mehmetk103@hotmail.com
-
Principal Investigator:
- Ali Aydın, Prof. Dr.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
closed reduction percutaneous fixation method
Patients with closed reduction percutaneous sacroiliac screw fixation of posterior pelvic ring due to unstable pelvic injury
|
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
|
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
|
closed reduction percutaneous fixation with open reduction internal fixation of the posterior pelvic ring
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
functional scoring
Time Frame: at least 6 months
|
Grading of outcomes using the clinical functional scoring system for pelvic injuries defined by Majeed
|
at least 6 months
|
|
radiological scoring
Time Frame: 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
|
at least 6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ataturk University Orthopedic
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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