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

• Sponsor: Christiana Care Health Services (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01876979
• Collaborator: (none)
• Enrollment: 5
• Locations: 2
• Arms: 2
• Duration (Months): 21
• Patients Per Site: 2.5
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Mandible Fracture	Device: IMF Screws; Device: Erich Arch Bars	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• 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?
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Time [Time duration of placement of device in operating room]

   Time duration for the application of device, in minutes.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Christiana Care Hospital	Newark	Delaware	United States	19718
2	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daniel Meara, Oral and Maxillofacial Surgery Resident, Christiana Care Health Services
• ClinicalTrials.gov Identifier: NCT01876979
• Other Study ID Numbers: CCC# 33082; DDD# 602252
• First Posted: Jun 13, 2013
• Last Update Posted: Jun 28, 2017
• Last Verified: May 1, 2017

• Additional relevant MeSH terms: Mandibular Fractures

Study Results

Participant Flow

Arm/Group Title	IMF Screws	Erich Arch Bars
Arm/Group Description	Use of IMF screws as a means to wire the jaws. IMF Screws: stainless steel screws placed in bone	Use of Erich Arch bars in the wiring of the jaws. Erich Arch Bars: Surgical braces wired around teeth
Period Title: Overall Study
STARTED	2	3
COMPLETED	0	0
NOT COMPLETED	2	3

Baseline Characteristics

Arm/Group Title	Intermaxillary Fixation Screws	Erich Arch Bars	Total
Arm/Group Description	Use of Intermaxillary Fixation screws as a means to wire the jaws. IMF Screws: stainless steel screws placed in bone	Use of Erich Arch bars in the wiring of the jaws. Erich Arch Bars: Surgical braces wired around teeth	Total of all reporting groups
Overall Participants	2	3	5
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	2 100%	3 100%	5 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	2 100%	3 100%	5 100%
Duration to Maxillomandibular Fixation (minutes) (minutes) [Mean (Full Range) ]
Mean (Full Range) [minutes]	17	40.3	28.7

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IMF Screws	Erich Arch Bars
Arm/Group Description	Use of IMF screws as a means to wire the jaws. IMF Screws: stainless steel screws placed in bone	Use of Erich Arch bars in the wiring of the jaws. Erich Arch Bars: Surgical braces wired around teeth
Measure Participants	2	3
Mean (Full Range) [minutes]	17	40.3

Adverse Events

Arm/Group Title	IMF Screws		Erich Arch Bars
Arm/Group Description	Use of IMF screws as a means to wire the jaws. IMF Screws: stainless steel screws placed in bone		Use of Erich Arch bars in the wiring of the jaws. Erich Arch Bars: Surgical braces wired around teeth
All Cause Mortality
	IMF Screws		Erich Arch Bars
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	IMF Screws		Erich Arch Bars
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	IMF Screws		Erich Arch Bars
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/3 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.