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

Prospective Randomized Comparison of Subcutaneous Internal Fixation and External Fixation for Anterior Pelvic Ring Fractures Requiring Stabilization

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02403154

Enrollment

Registered

2015-03-31

Start date

2014-04-30

Completion date

2016-06-30

Last updated

2018-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Pelvic Ring Fractures

Keywords

Anterior pelvic ring, Internal fixation, External fixation, Orthopaedic, Orthopedic, pubic rami

Brief summary

Detailed description

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. This type of injury requires follow up at 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months. At each follow up appointment, the patient will be asked to complete surveys as part of the PROMIS series (Patient Reported Outcomes Measurement Information System) which will include surveys about physical function, pain, mobility, sex life satisfaction, depression, and for male patients, a survey about erectile function. In addition to the PROMIS questionnaire for pain, the investigators will also use a visual analogue pain scale and ask what the patient's satisfaction is on a scale of 0-100%. If the patient does not report to clinic for follow up, the research coordinator will call the patient to complete the study questionnaires.

Interventions

PROCEDUREInternal Fixator

Internal fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are inserted under the skin, internally.

PROCEDUREExternal fixator

External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Functional Outcomes (PROMIS v1.2-Physical Function Instrument)	24 hrs - 24 months	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.

Secondary

Measure	Time frame	Description
Infection Rates	24 hours - 24 months	We will compare the rate of infection between the two interventions.
Revision Surgery Rates	24 hours - 24 months	We will compare the revision surgery rates between the two interventions.
Implant Breakage or Failure Rates	24 hours - 24 months	We will compare the implant failure/breakage rate between the two interventions.
Predictors of Outcome (Factors Such as Age, Gender, BMI, Additional Injuries)	24 hours - 24 months	We will evaluate factors such as age, gender, BMI, additional injuries to see if they help predict outcome
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)	24 hours - 24 months	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.
Health-related Qualify of Life	24 hours - 24 months	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Randomized to Internal Fixator Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be internal fixator. Internal Fixator: Internal fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are inserted under the skin, internally.	2
Randomized to External Fixator Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be external fixator. External fixator: External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body.	0
Observational - Internal Fixator 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. Internal Fixator: Internal fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are inserted under the skin, internally.	1
Observational - External Fixator 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. External fixator: External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body.	1
Total	4

Baseline characteristics

Characteristic	Randomized to External Fixator	Observational - Internal Fixator	Observational - External Fixator	Total	Randomized to Internal Fixator
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants	1 Participants	1 Participants	4 Participants	2 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants	—
Sex: Female, Male Female	0 Participants	1 Participants	0 Participants	2 Participants	1 Participants
Sex: Female, Male Male	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	0 / 2	0 / 0	0 / 1	0 / 1
serious Total, serious adverse events	0 / 2	0 / 0	0 / 1	0 / 1

Outcome results

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.

Time frame: 24 hrs - 24 months

Population: No data was analyzed for this study. The PI left our institution and the study was pre-maturely closed. With such a small patient population, the data that was collected was not analyzed because achieving statistical significance was not possible.

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.