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

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: Mandible Fracture
• Intervention / Treatment: Device: IMF Screws; Device: Erich Arch Bars

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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 duration for the application of device, in minutes.	Time duration of placement of device in operating room

Collaborators and Investigators

• 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

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: Nervous System Diseases; Fractures, Bone; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Skull Fractures; Mandibular Fractures
• 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