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

NCT01876979 | Terminated Results

• 2 other identifiers: CCC# 33082DDD# 602252
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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.

Conditions

Mandible Fracture

Outcome Measures

Primary Outcomes (1)

• Time

  Time duration for the application of device, in minutes.

  Time duration of placement of device in operating room

Study Arms (2)

IMF Screws

ACTIVE COMPARATOR

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

Device: IMF Screws

Erich Arch Bars

ACTIVE COMPARATOR

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

Device: Erich Arch Bars

Interventions

IMF Screws DEVICE

stainless steel screws placed in bone

Also known as: Synthes IMF screws

IMF Screws

Erich Arch Bars DEVICE

Surgical braces wired around teeth

Erich Arch Bars

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Christiana Care Health Services: lead

Study Sites (2)

Christiana Care Hospital

Newark, Delaware, 19718, United States

Location

Wilmington Hospital

Wilmington, Delaware, 19801, United States

Location

MeSH Terms

Conditions

Mandibular Fractures

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Department Chair
• Organization: OMFS & HD

dmeara@christianacare.org

302-320-6458

Study Officials

• Daniel Meara, MD

  Christiana Care Health Services

  PRINCIPAL INVESTIGATOR

• Daniel J Meara, MS, MD, DMD

  Christiana Care Health Services

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oral and Maxillofacial Surgery Resident

Study Record Dates

• First Submitted: June 11, 2013
• First Posted: June 13, 2013
• Study Start: July 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 28, 2017
• Results First Posted: June 28, 2017

Record last verified: 2017-05

Locations

US (2)