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Arch Bars vs. IMF (Intermaxillary Fixation) Screws: Cost Effectiveness Based on Time Duration of Device Placement.

This study has been terminated.
(Extended study duration)
Sponsor:
Information provided by (Responsible Party):
Daniel Meara, Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT01876979
First received: June 11, 2013
Last updated: May 26, 2017
Last verified: May 2017
  Purpose
Determining the cost effectiveness, based on the time duration of application, of two methods of wiring the jaws together during surgery to repair mandible fractures. One technique is more expensive but faster in application, while the other is less expensive and takes more time to apply.

Condition Intervention
Mandible Fracture Device: IMF Screws Device: Erich Arch Bars

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Erich Arch Bars vs. IMF Screws for Placement of Maxillomandibular Fixation: Which is More Time Effective in the Operating Room Setting?

Further study details as provided by Daniel Meara, Christiana Care Health Services:

Primary Outcome Measures:
  • Time [ Time Frame: Time duration of placement of device in operating room ]
    Time duration for the application of device, in minutes.


Enrollment: 5
Study Start Date: July 2013
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IMF Screws
Use of IMF screws as a means to wire the jaws.
Device: IMF Screws
stainless steel screws placed in bone
Other Name: Synthes IMF screws
Active Comparator: Erich Arch Bars
Use of Erich Arch bars in the wiring of the jaws.
Device: Erich Arch Bars
Surgical braces wired around teeth

Detailed Description:

Purpose:

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. Patients who sustain mandible fractures that meet the inclusion criteria will be randomized to one of the two treatment types listed above. 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 18-70
  • Patients with no greater than one (1) open fracture of the tooth-bearing mandible
  • Mandibular angle fractures ± Ramus or subcondylar fracture
  • Body/symphysis ± subcondylar
  • Isolated angle fracture
  • Isolate subcondylar fractures
  • Bilateral subcondylar fractures
  • Any condylar head/neck fracture requiring treatment
  • Patients who are candidates for treatment of their fractures in the operating room setting

Exclusion Criteria:

  • Patients younger than 18 or older than 70
  • Patients with developing tooth buds anterior to the second molars
  • Patients with inadequate stability of occlusion
  • Edentulism
  • 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
  • The presence of any of the following:
  • Greater than one (1) open fracture of the tooth-bearing mandible
  • Bilateral angle fractures are exempt from this
  • Comminuted fractures of the mandible
  • Concomitant infection, or osteomyelitis of the mandible
  • Mechanism of injury
  • Pathologic fracture
  • Gun-shot wounds
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01876979

Locations
United States, Delaware
Christiana Care Hospital
Newark, Delaware, United States, 19718
Wilmington Hospital
Wilmington, Delaware, United States, 19801
Sponsors and Collaborators
Christiana Care Health Services
Investigators
Principal Investigator: Daniel Meara, MD Christiana Care Health Services
Study Chair: Daniel J Meara, MS, MD, DMD Christiana Care Health Services
  More Information

Responsible Party: Daniel Meara, Oral and Maxillofacial Surgery Resident, Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT01876979     History of Changes
Other Study ID Numbers: CCC# 33082
DDD# 602252 ( Other Identifier: ChristianaCHS )
Study First Received: June 11, 2013
Results First Received: November 22, 2016
Last Updated: May 26, 2017

Additional relevant MeSH terms:
Mandibular Fractures
Jaw Fractures
Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Skull Fractures
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on August 18, 2017