← Back to Search

Other

Comparison of Subcutaneous INFIX and EXFIX for Anterior Pelvic Ring Fractures Requiring Stabilization

N/A
Waitlist Available
Led By Michael Zlowodzki, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours - 24 months
Awards & highlights
No Placebo-Only Group

Summary

The purpose of this research is to compare patient outcomes of two treatment methods that are currently used as standard of care to treat anterior pelvic ring injuries that require stabilization. The two treatment methods are subcutaneous internal fixation (INFIX) and external fixation (EXFIX). Patients will be given the opportunity to opt out of randomization and participate in one of the observational arms. The first observational arm is comprised of those patients who do not want to randomize and they will undergo anterior pelvic ring stabilization according to the treating surgeon's discretion. The second observational arm will be comprised of patients who consent to be in the study but whose pelvic ring fractures do not require any form of anterior pelvic internal fixation based on the treating surgeon's opinion.

Eligible Conditions
  • Anterior Pelvic Fracture

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours - 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours - 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Functional Outcomes (PROMIS v1.2-Physical Function Instrument)
Secondary study objectives
Compare the Functional Outcome Scores (PROMIS Pain Interference, PROMIS Mobility, PROMIS Global Satisfaction With Sex Life, PROMIS Depression, Majeed Score, SF-12, VAS, Patient Satisfaction Score, and (Only in Men) PROMIS Erectile Function)
Health-related Qualify of Life
Implant Breakage or Failure Rates
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Randomized to Internal FixatorExperimental Treatment1 Intervention
Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be internal fixator.
Group II: Randomized to External FixatorExperimental Treatment1 Intervention
Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be external fixator.
Group III: Observational - Internal FixatorExperimental Treatment1 Intervention
Patient signed consent but did not want to randomize their procedure and either the treating physician selected the internal fixator intervention based on their preference for the specific case or the patient chose the internal fixator.
Group IV: Observational - External FixatorExperimental Treatment1 Intervention
Patient signed consent but did not want to randomize their procedure and either the treating physician selected the external fixator intervention based on their preference for the specific case or the patient chose the external fixator.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
External fixator
2011
N/A
~70

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
1,042 Previous Clinical Trials
1,316,643 Total Patients Enrolled
Michael Zlowodzki, MDPrincipal InvestigatorIndiana University Health
1 Previous Clinical Trials
4 Total Patients Enrolled
~0 spots leftby Dec 2025