Anterior Pelvic Ring Fractures Clinical Trial
Official title:
Prospective Randomized Comparison of Subcutaneous Internal Fixation and External Fixation for Anterior Pelvic Ring Fractures Requiring Stabilization
| Verified date | February 2018 |
| Source | Indiana University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 4 |
| Est. completion date | June 2016 |
| Est. primary completion date | June 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 120 Years |
| Eligibility |
Inclusion Criteria: - One or more fractures of the anterior pelvic ring (pubic rami) - Need for anterior pelvic ring stabilization - Injury amenable to external as well as subcutaneous internal fixation per the treating surgeon's opinion - Patient was ambulatory prior to sustaining the injury - Provision of informed consent by patient or proxy Exclusion Criteria: - Patients with a slim build with little subcutaneous fat who cannot be treated with a subcutaneous internal fixator based on the treating surgeon's opinion - Patients who are deemed not likely to follow-up (e.g. patients who live more than 50 miles away and patients with no fixed address) - Moderately or severely cognitively impaired patients - Pregnant women - Prisoners |
| Country | Name | City | State |
|---|---|---|---|
| United States | Indiana University Health Methodist Hospital | Indianapolis | Indiana |
| Lead Sponsor | Collaborator |
|---|---|
| Indiana University |
United States,
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* Note: There are 31 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Functional Outcomes (PROMIS v1.2-Physical Function Instrument) | The primary objective is to compare functional outcomes between subcutaneous internal fixation and external fixation as measured by the PROMIS v1.2-Physical Function instrument. | 24 hrs - 24 months | |
| Secondary | Implant Breakage or Failure Rates | We will compare the implant failure/breakage rate between the two interventions. | 24 hours - 24 months | |
| Secondary | Infection Rates | We will compare the rate of infection between the two interventions. | 24 hours - 24 months | |
| Secondary | Revision Surgery Rates | We will compare the revision surgery rates between the two interventions. | 24 hours - 24 months | |
| Secondary | Health-related Qualify of Life | We will ask patients multiple questionnaires to assess their quality of life after surgery. These questionnaires include: 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. | 24 hours - 24 months | |
| Secondary | Predictors of Outcome (Factors Such as Age, Gender, BMI, Additional Injuries) | We will evaluate factors such as age, gender, BMI, additional injuries to see if they help predict outcome | 24 hours - 24 months | |
| Secondary | 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) | We will ask patients multiple questionnaires to asses their functional outcomes after surgery. These questionnaires include: 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. | 24 hours - 24 months |