Comparison of INFIX and Plating for Pelvic Ring Injuries With Symphysis Disruptions
NCT ID: NCT02399319
Last Updated: 2018-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
4 participants
INTERVENTIONAL
2014-10-31
2016-07-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Randomized to Internal Fixator
Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention would 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 Symphyseal Plate
Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention would be internal plating of the symphysis.
Symphyseal Plate
A plate that spans across the symphysis to maintain reduction and stability.
Observational - Internal Fixator
Patient signed consent but did not want to randomize their procedure and the treating physician selected the internal fixator intervention based on their opinion of how best to treat the specific case.
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 - Symphyseal Plate
Patient signed consent but did not want to randomize their procedure and the treating physician selected internal plating of the symphysis based on their opinion of how best to treat the specific case.
Symphyseal Plate
A plate that spans across the symphysis to maintain reduction and stability.
Interventions
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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.
Symphyseal Plate
A plate that spans across the symphysis to maintain reduction and stability.
Eligibility Criteria
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Inclusion Criteria
* Need for anterior pelvic ring stabilization
* Injury amenable to plating 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 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
18 Years
ALL
No
Sponsors
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Indiana University
OTHER
Responsible Party
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Principal Investigators
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Michael Zlowodzki, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University Health
Locations
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Indiana University Health Methodist Hospital
Indianapolis, Indiana, United States
Countries
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References
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Vallier HA, Cureton BA, Schubeck D, Wang XF. Functional outcomes in women after high-energy pelvic ring injury. J Orthop Trauma. 2012 May;26(5):296-301. doi: 10.1097/BOT.0b013e318221e94e.
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Vallier HA, Cureton BA, Schubeck D. Pregnancy outcomes after pelvic ring injury. J Orthop Trauma. 2012 May;26(5):302-7. doi: 10.1097/BOT.0b013e31822428c5.
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Vaidya R, Kubiak EN, Bergin PF, Dombroski DG, Critchlow RJ, Sethi A, Starr AJ. Complications of anterior subcutaneous internal fixation for unstable pelvis fractures: a multicenter study. Clin Orthop Relat Res. 2012 Aug;470(8):2124-31. doi: 10.1007/s11999-011-2233-z.
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Related Links
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PROMIS outcome questionnaires
Other Identifiers
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1403899155
Identifier Type: -
Identifier Source: org_study_id
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