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

May 26, 2017 updated by: Daniel Meara, Christiana Care Health Services

Erich Arch Bars vs. IMF Screws for Placement of Maxillomandibular Fixation: Which is More Time Effective in the Operating Room Setting?

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19718
        • Christiana Care Hospital
      • Wilmington, Delaware, United States, 19801
        • Wilmington Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time
Time Frame: Time duration of placement of device in operating room
Time duration for the application of device, in minutes.
Time duration of placement of device in operating room

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

June 11, 2013

First Submitted That Met QC Criteria

June 11, 2013

First Posted (Estimate)

June 13, 2013

Study Record Updates

Last Update Posted (Actual)

June 28, 2017

Last Update Submitted That Met QC Criteria

May 26, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCC# 33082
  • DDD# 602252 (Other Identifier: ChristianaCHS)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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