Trial Outcomes & Findings for Comparison of Subcutaneous INFIX and EXFIX for Anterior Pelvic Ring Fractures Requiring Stabilization (NCT NCT02403154)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

24 hrs - 24 months

Results posted on

2018-03-13

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	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.
Overall Study STARTED	2	1	1
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	2	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Randomized to Internal Fixator n=2 Participants 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.	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.	Observational - Internal Fixator n=1 Participants 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.	Observational - External Fixator n=1 Participants 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.	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=2 Participants	0 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=2 Participants	0 Participants	1 Participants n=1 Participants	1 Participants n=1 Participants	4 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=2 Participants	0 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	1 Participants n=2 Participants	0 Participants	1 Participants n=1 Participants	0 Participants n=1 Participants	2 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=2 Participants	0 Participants	0 Participants n=1 Participants	1 Participants n=1 Participants	2 Participants n=4 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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.

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.