Orthopedic DisorderNCT05473611
Open Reduction Internal Versus Percutaneous Sacroiliac Screw Fixation in Unstable Posterior Ring Injury of Pelvic
An observational study of Orthopedic Disorder, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Orthopedic Disorder
- What is being tested?
- closed reduction percutaneous fixation with open reduction internal fixation of the posterior pelvic ring
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2022to 12 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18-65 years who suffered pelvic injury admitted to Atatürk University Research Hospital
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ataturk University Faculty of Medicine
Erzurum, Yakutiye, 25050
Ataturk University Faculty of Medicine, doctorate, 905324556473, mehmetk103@hotmail.com
Ali Aydın, Prof. Dr.
About this study
Official title: Comparison of Open Reduction Internal Fixation and Percutaneous Sacroiliac Screw Fixation in Unstable Posterior Ring Injury of The Pelvic
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.
Read the 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
- Conditions
- Orthopedic Disorder
- Being tested
- closed reduction percutaneous fixation with open reduction internal fixation of the posterior pelvic ring
- Keywords
- instabil pelvic injury, percutaneus sacroiliac screw
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closed reduction percutaneous fixation with open reduction internal fixation of the posterior pelvic ringProcedure or surgery
closed reduction percutaneous fixation with open reduction internal fixation of the posterior pelvic ring
| Study group | Role | What they receive |
|---|---|---|
| closed reduction percutaneous fixation method | Patients with closed reduction percutaneous sacroiliac screw fixation of posterior pelvic ring due to unstable pelvic injury Receives: 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 Receives: 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 Receives: Procedure: closed reduction percutaneous fixation with open reduction internal fixation of the posterior pelvic ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional scoring
Grading of outcomes using the clinical functional scoring system for pelvic injuries defined by Majeed
Measured: 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
Measured: at least 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start10 Mar 2022
- Primary completion10 Nov 2022 (estimated)
- Study completion12 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Koçaslan, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473611
- Sponsor's protocol ID
- Ataturk University Orthopedic
- Status last verified
- Aug 2022
- First submitted
- 22 Jul 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Open Reduction Internal Fixation and Percutaneous Sacroiliac Screw Fixation in Unstable Posterior Ring Injury of The Pelvic
- ClinicalTrials.gov ID
- NCT05473611
- Acronym / sponsor ID
- Ataturk University Orthopedic
- Conditions
- Orthopedic Disorder
- Keywords
- instabil pelvic injury, percutaneus sacroiliac screw
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 10 Nov 2022 (estimated)
- Study completion
- 12 Mar 2023 (estimated)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| closed reduction percutaneous fixation method | – | Procedure: closed reduction percutaneous fixation with open reduction internal fixation of the posterior pelvic ringPatients with closed reduction percutaneous sacroiliac screw fixation of posterior pelvic ring due to unstable pelvic injury |
| open reduction anterior sacroiliac approach | – | Procedure: closed reduction percutaneous fixation with open reduction internal fixation of the posterior pelvic ringPatients with fixation of the posterior pelvic ring by open reduction anterior approach due to unstable pelvic injury |
| open reduction posterior sacroiliac approach | – | Procedure: closed reduction percutaneous fixation with open reduction internal fixation of the posterior pelvic ringPatients with fixation of the posterior pelvic ring by open reduction posterior approach due to unstable pelvic injury |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-65 years who suffered pelvic injury admitted to Atatürk University Research Hospital
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| closed reduction percutaneous fixation with open reduction internal fixation of the posterior pelvic ringclosed reduction percutaneous fixation with open reduction internal fixation of the posterior pelvic ring | Procedure or surgery | closed reduction percutaneous fixation method, open reduction anterior sacroiliac approach, open reduction posterior sacroiliac approach |
Primary outcome
functional scoring
Time frame: at least 6 months
Grading of outcomes using the clinical functional scoring system for pelvic injuries defined by Majeed
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic Disorder, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Aydin (+905386802430, draliaydin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional scoring (time frame: at least 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.