Arch Bars vs. IMF (Intermaxillary Fixation) Screws: Cost Effectiveness

Mandible Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01876979
• Other study ID #: CCC# 33082
• Secondary ID: DDD# 602252
• Status: Terminated
• Phase: N/A
• First received: June 11, 2013
• Last updated: April 29, 2015
• Start date: July 2013
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Determining the cost effectiveness 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Mandible Fracture
• Mandibular Fractures

Intervention

Device:
• IMF Screws
stainless steel screws placed in bone
• Erich Arch Bars
Surgical braces wired around teeth

Locations

Country	Name	City	State
United States	Christiana Care Hospital	Newark	Delaware
United States	Wilmington Hospital	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost	Duration of application of device in minutes multiplied by cost of operating room expenses in dollars per minute. This total added to the cost of the device.	Duration of placement of device in operating room	No