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

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ClinicalTrials.gov Identifier: NCT02403154
Recruitment Status : Terminated (Principle Investigator left institution)
First Posted : March 31, 2015
Results First Posted : December 19, 2017
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Indiana University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Anterior Pelvic Ring Fractures
Interventions Procedure: Internal Fixator
Procedure: External fixator
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Randomized to Internal Fixator Randomized to External Fixator Observational - Internal Fixator Observational - External Fixator
Hide Arm/Group Description

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.

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.

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.

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.

Period Title: Overall Study
Started 2 0 1 1
Completed 0 0 0 0
Not Completed 2 0 1 1
Arm/Group Title Randomized to Internal Fixator Randomized to External Fixator Observational - Internal Fixator Observational - External Fixator Total
Hide Arm/Group Description

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.

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 2 0 1 1 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 0 participants 1 participants 1 participants 4 participants
<=18 years
0
   0.0%
0
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
0
1
 100.0%
1
 100.0%
4
 100.0%
>=65 years
0
   0.0%
0
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 0 participants 1 participants 1 participants 4 participants
Female
1
  50.0%
0
1
 100.0%
0
   0.0%
2
  50.0%
Male
1
  50.0%
0
0
   0.0%
1
 100.0%
2
  50.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Functional Outcomes (PROMIS v1.2-Physical Function Instrument)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Randomized to Internal Fixator Randomized to External Fixator Observational - Internal Fixator Observational - External Fixator
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Implant Breakage or Failure Rates
Hide Description We will compare the implant failure/breakage rate between the two interventions.
Time Frame 24 hours - 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
No analyses were done on this study. We did not enroll enough patients in order to come to any conclusions prior to the PI leaving the institution.
Arm/Group Title Randomized to Internal Fixator Randomized to External Fixator Observational - Internal Fixator Observational - External Fixator
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Infection Rates
Hide Description We will compare the rate of infection between the two interventions.
Time Frame 24 hours - 24 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Revision Surgery Rates
Hide Description We will compare the revision surgery rates between the two interventions.
Time Frame 24 hours - 24 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Health-related Qualify of Life
Hide Description 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.
Time Frame 24 hours - 24 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Predictors of Outcome (Factors Such as Age, Gender, BMI, Additional Injuries)
Hide Description We will evaluate factors such as age, gender, BMI, additional injuries to see if they help predict outcome
Time Frame 24 hours - 24 months
Outcome Measure Data Not Reported
7.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame 24 hours - 24 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Randomized to Internal Fixator Randomized to External Fixator Observational - Internal Fixator Observational - External Fixator
Hide Arm/Group Description

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.

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.

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.

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.

All-Cause Mortality
Randomized to Internal Fixator Randomized to External Fixator Observational - Internal Fixator Observational - External Fixator
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Randomized to Internal Fixator Randomized to External Fixator Observational - Internal Fixator Observational - External Fixator
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/0   0/1 (0.00%)   0/1 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Randomized to Internal Fixator Randomized to External Fixator Observational - Internal Fixator Observational - External Fixator
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/0   0/1 (0.00%)   0/1 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Krista Brown, Clinical Research Coordinator
Organization: Indiana University
Phone: 317-963-1944
EMail: brownkm@indiana.edu
Publications:
Layout table for additonal information
Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT02403154    
Other Study ID Numbers: 1404651343
First Submitted: March 23, 2015
First Posted: March 31, 2015
Results First Submitted: August 11, 2017
Results First Posted: December 19, 2017
Last Update Posted: March 13, 2018