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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Christiana Care Health Services
Sponsor:
Information provided by (Responsible Party):
Geoffrey Zinberg, Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT01876979
First received: June 11, 2013
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Mandible Fracture
Device: IMF Screws
Device: Erich Arch Bars

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Erich Arch Bars vs. IMF Screws for Placement of Maxillomandibular Fixation: Which is More Cost Effective in the Operating Room Setting?

Resource links provided by NLM:


Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • Cost [ Time Frame: Duration of placement of device in operating room ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 70
Study Start Date: July 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01876979

Contacts
Contact: Geoffrey Zinberg, DMD 302-428-5750 gzinberg@christianacare.org
Contact: Robert Horne, DDS 302-428-5730 rhorne@christianacare.org

Locations
United States, Delaware
Christiana Care Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Geoffrey Zinberg, DMD    302-428-5750    gzinberg@christianacare.org   
Principal Investigator: Geoffrey Zinberg, DMD         
Sub-Investigator: Robert Horne, DDS         
Sub-Investigator: Daniel Meara, MS, MD, DMD         
Wilmington Hospital Recruiting
Wilmington, Delaware, United States, 19801
Contact: Geoffrey Zinberg, DMD    302-428-5750    gzinberg@christianacare.org   
Principal Investigator: Geoffrey Zinberg, DMD         
Sub-Investigator: Robert Horne, DDS         
Sub-Investigator: Daniel Meara, MS, MD, DMD         
Sponsors and Collaborators
Christiana Care Health Services
Investigators
Principal Investigator: Geoffrey Zinberg, DMD Christiana Care Health Services
Study Director: Robert Horne, DDS Christiana Care Health Services
Study Chair: Daniel J Meara, MS, MD, DMD Christiana Care Health Services
  More Information

No publications provided

Responsible Party: Geoffrey Zinberg, Oral and Maxillofacial Surgery Resident, Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT01876979     History of Changes
Other Study ID Numbers: CCC# 33082, DDD# 602252
Study First Received: June 11, 2013
Last Updated: July 11, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Mandibular Fractures
Jaw Fractures
Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Wounds and Injuries
Skull Fractures
Fractures, Bone

ClinicalTrials.gov processed this record on October 01, 2014