U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

Listing a study does not mean it has been evaluated by the U.S. Federal Government. For general information, Learn About Clinical Studies. To identify which option of wiring the jaws together during treatment of mandible fractures is more cost effective to the patient, Erich arch bars or IMF (Intermaxillary Fixation) screws.
159 0 obj <> endobj 157 0 obj <> endobj 158 0 obj <>stream COVID-19 is an emerging, rapidly evolving situation. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Imf ScreW Set For intermaxillary fixation SurgIcal technIque Table of var base_url = "https://www.medicaldevices24.com/"; var tpl_folder = "https://www.medicaldevices24.com/public/tpl";

The overall treatment in both categories is consistent with the standard of care, the only difference being the method utilized to achieve intermaxillary fixation during the course of the surgery. 4 Synthes IMF Screw Set Surgical technique The following surgical technique assumes that the first screw is placed in the maxilla.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. endstream endobj 116 0 obj <> endobj 154 0 obj <> endobj 151 0 obj <. Other Name: Synthes IMF screws. This site is published by the DePuy Synthes Companies, which are solely responsible for its content.

18 Years to 70 Years   (Adult, Older Adult), Wilmington, Delaware, United States, 19801, Daniel Meara, Oral and Maxillofacial Surgery Resident, Christiana Care Health Services, Time [ Time Frame: Time duration of placement of device in operating room ], Patients with no greater than one (1) open fracture of the tooth-bearing mandible, Mandibular angle fractures ± Ramus or subcondylar fracture, Any condylar head/neck fracture requiring treatment, Patients who are candidates for treatment of their fractures in the operating room setting, Patients younger than 18 or older than 70, Patients with developing tooth buds anterior to the second molars, Patients with inadequate stability of occlusion, Unstable vertical and horizontal stops to the occlusion, Patients with disorders affecting bone healing, metabolism and turnover, Those patients on bisphosphonates, oral or IV, Patients with evidence of intrabony pathology of the mandible or maxilla, Greater than one (1) open fracture of the tooth-bearing mandible, Bilateral angle fractures are exempt from this, Concomitant infection, or osteomyelitis of the mandible. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01876979.

Intermaxillary fixation (IMF) is a technique utilized in maxillofacial surgery to relate the maxilla and mandible in three dimensions of space. google_ad_client: "ca-pub-5568848730124950", Use of Erich Arch bars in the wiring of the jaws. Why Should I Register and Submit Results?

}); BONE FIXATION SCREWS, TENDONS AND LIGAMENTS SCREWS - OTHERS, VERSAFX II CEPHALIC SCREW - 00-1193-01X-XX, CEPHALIC SCREW RATCHET + STERILE COMPRESSION SCREW - 250.55.XXXR, Complete classification of medical devices, Progressive number assigned to the medical device, End of validity is not present for the medical device.
Device: Erich Arch Bars Surgical braces wired around teeth. Please remove one or more studies before adding more. (adsbygoogle = window.adsbygoogle || []).push({

%PDF-1.3 %���� enable_page_level_ads: true Choosing to participate in a study is an important personal decision. Use of IMF screws as a means to wire the jaws. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). Outcome Measures. if( $robots ) : ?> Erich Arch Bars vs. IMF Screws for Placement of Maxillomandibular Fixation: Which is More Time Effective in the Operating Room Setting? Includes a few guide wires. Active Comparator: Erich Arch Bars Use of Erich Arch bars in the wiring of the jaws. Talk with your doctor and family members or friends about deciding to join a study.

Time duration for the application of device, in minutes.




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