Single Trans-sacral Screw Versus Two Iliosacral Screws

NCT ID: NCT03944174

Last Updated: 2019-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-30

Study Completion Date

2020-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

1. To compare Single Trans-sacral screw fixation vs. two Ilio-Sacral screws fixation as regard time for starting weight bearing.
2. To compare between functional outcome using the Majeed Pelvic Score.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Sacroiliac screws (SISs) have been used since Vidal et al introduced them in 1973. Since that, SIS fixation has become a common technology in fixing pelvic posterior ring injuries with important progress in the past 20 years. Currently, SIS fixation represents the only minimally invasive technique to stabilize the posterior pelvic ring. For that reason, it is steadily gaining popularity, becoming one of the most commonly used techniques. The sacrum, serving as the foundation of the spine, transmits the stress between spine and pelvis through sacroiliac joints. Thus, the goal of surgical fixation is the reconstruction of the spino-pelvic-junction to allow early weight-bearing and to facilitate nursing care, particularly for multiple injured patients.

As a result of the deforming forces acting perpendicular to the implant axis, routine ilio-sacral screws fixation may not provide adequate stabilization, especially in certain unstable injuries. Longer trans-sacral screws that traverse the entire upper sacrum and exit the contralateral iliac cortex may improve holding power and also stabilize concomitant contralateral posterior pelvic injuries. These trans-sacral screws are reliably safe to insert using routine intraoperative fluoroscopy, and they provide durable fixation.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pelvic Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single Trans-sacral Screw

Fixation of unstable pelvic fractures

Intervention Type PROCEDURE

Percutaneous fixation of both iliac bones through the sacrum using one screw

Two Iliosacral Screws

Fixation of unstable pelvic fractures

Intervention Type PROCEDURE

Percutaneous fixation of both iliac bones through the sacrum using one screw

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fixation of unstable pelvic fractures

Percutaneous fixation of both iliac bones through the sacrum using one screw

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Unstable pelvic fractures Tile type B \& C.
2. Sacral Fractures.
3. Recent trauma: less than 1 week from date of trauma.
4. Neurologically free.
5. Injury Severity Score (ISS) \< 18.

Exclusion Criteria

1. Spino-pelvic dissociation.
2. Comminuted fractures
3. Bilat. Sacral fractures.
4. Sacral insufficiency.
5. Patients with associated comorbidities "eg. uncontrolled diabetes mellitus , chronic renal failure, etc.".
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohammed Elhady Hassan Mohammed Ali

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Trans-sacral screw fixation

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.