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

Primary Purpose

Mandible Fracture

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IMF Screws
Erich Arch Bars
Sponsored by
Christiana Care Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mandible Fracture

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Christiana Care Hospital
  • Wilmington Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

IMF Screws

Erich Arch Bars

Arm Description

Use of IMF screws as a means to wire the jaws.

Use of Erich Arch bars in the wiring of the jaws.

Outcomes

Primary Outcome Measures

Time
Time duration for the application of device, in minutes.

Secondary Outcome Measures

Full Information

First Posted
June 11, 2013
Last Updated
May 26, 2017
Sponsor
Christiana Care Health Services
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1. Study Identification

Unique Protocol Identification Number
NCT01876979
Brief Title
Arch Bars vs. IMF (Intermaxillary Fixation) Screws: Cost Effectiveness Based on Time Duration of Device Placement.
Official Title
Erich Arch Bars vs. IMF Screws for Placement of Maxillomandibular Fixation: Which is More Time Effective in the Operating Room Setting?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Extended study duration
Study Start Date
July 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Christiana Care Health Services

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mandible Fracture

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMF Screws
Arm Type
Active Comparator
Arm Description
Use of IMF screws as a means to wire the jaws.
Arm Title
Erich Arch Bars
Arm Type
Active Comparator
Arm Description
Use of Erich Arch bars in the wiring of the jaws.
Intervention Type
Device
Intervention Name(s)
IMF Screws
Other Intervention Name(s)
Synthes IMF screws
Intervention Description
stainless steel screws placed in bone
Intervention Type
Device
Intervention Name(s)
Erich Arch Bars
Intervention Description
Surgical braces wired around teeth
Primary Outcome Measure Information:
Title
Time
Description
Time duration for the application of device, in minutes.
Time Frame
Time duration of placement of device in operating room

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Meara, MD
Organizational Affiliation
Christiana Care Health Services
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel J Meara, MS, MD, DMD
Organizational Affiliation
Christiana Care Health Services
Official's Role
Study Chair
Facility Information:
Facility Name
Christiana Care Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Wilmington Hospital
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19801
Country
United States

12. IPD Sharing Statement

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

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