Comparison of Subcutaneous INFIX and EXFIX for Anterior Pelvic Ring Fractures Requiring Stabilization
NCT ID: NCT02403154
Last Updated: 2018-03-13
Study Results
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View full resultsBasic Information
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TERMINATED
NA
4 participants
INTERVENTIONAL
2014-04-30
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
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 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
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
120 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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Gansslen A, Pohlemann T, Krettek C. [A simple supraacetabular external fixation for pelvic ring fractures]. Oper Orthop Traumatol. 2005 Sep;17(3):296-312. doi: 10.1007/s00064-005-1134-2. German.
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Lindahl J, Hirvensalo E, Bostman O, Santavirta S. Failure of reduction with an external fixator in the management of injuries of the pelvic ring. Long-term evaluation of 110 patients. J Bone Joint Surg Br. 1999 Nov;81(6):955-62. doi: 10.1302/0301-620x.81b6.8571.
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Mears DC, Fu FH. Modern concepts of external skeletal fixation of the pelvis. Clin Orthop Relat Res. 1980 Sep;(151):65-72.
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Riemer BL, Butterfield SL, Diamond DL, Young JC, Raves JJ, Cottington E, Kislan K. Acute mortality associated with injuries to the pelvic ring: the role of early patient mobilization and external fixation. J Trauma. 1993 Nov;35(5):671-5; discussion 676-7. doi: 10.1097/00005373-199311000-00003.
Wild JJ Jr, Hanson GW, Tullos HS. Unstable fractures of the pelvis treated by external fixation. J Bone Joint Surg Am. 1982 Sep;64(7):1010-20.
Cole PA, Gauger EM, Anavian J, Ly TV, Morgan RA, Heddings AA. Anterior pelvic external fixator versus subcutaneous internal fixator in the treatment of anterior ring pelvic fractures. J Orthop Trauma. 2012 May;26(5):269-77. doi: 10.1097/BOT.0b013e3182410577.
Gardner MJ, Mehta S, Mirza A, Ricci WM. Anterior pelvic reduction and fixation using a subcutaneous internal fixator. J Orthop Trauma. 2012 May;26(5):314-21. doi: 10.1097/BOT.0b013e318220bb22.
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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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Scaglione M, Parchi P, Digrandi G, Latessa M, Guido G. External fixation in pelvic fractures. Musculoskelet Surg. 2010 Nov;94(2):63-70. doi: 10.1007/s12306-010-0084-5. Epub 2010 Nov 18.
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Mullis BH, Sagi HC. Minimum 1-year follow-up for patients with vertical shear sacroiliac joint dislocations treated with iliosacral screws: does joint ankylosis or anatomic reduction contribute to functional outcome? J Orthop Trauma. 2008 May-Jun;22(5):293-8. doi: 10.1097/BOT.0b013e31816b6b4e.
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Related Links
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PROMIS outcome questionnaires
Other Identifiers
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1404651343
Identifier Type: -
Identifier Source: org_study_id
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