A Comparison of Stryker Hybrid Arch Bars (Hybrid)
Primary Purpose
Fracture Mandible
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stryker Hybrid
Erich
Sponsored by
About this trial
This is an interventional treatment trial for Fracture Mandible
Eligibility Criteria
Inclusion Criteria:
- Mandible fracture involving subcondyle, ramus, angle, body, parasymphysis and symphysis
- Age 18 years - 90 years
- Ability to give informed consent
- Minimum 6 weeks follow-up
- Pre and post-operative panoramic xrays
Exclusion Criteria:
- Comminuted fractures
- Infected fractures
- Previously treated fractures
- Complete edentulism
- Gun shot wounds
- Pregnancy or breast feeding
Sites / Locations
- Grady Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hybrid
Erich
Arm Description
Placement of Hybrid arch bars for open or closed reduction of mandible fractures
Placement of Erich archbars for open or closed reduction of mandible fractures
Outcomes
Primary Outcome Measures
Time to Place Archbars
Time taken to place archbars
Secondary Outcome Measures
Number of Participants With Fracture Healing at 6 Weeks
Radiographic healing
Number of Participants With Complications Including Loosening of Archbars, Loosening of MMF, or Damage to Adjacent Teeth and Structures
assess operative and post-operative complications to include loosening of archbars, loosening of MMF if stratified to closed reduction and damage to adjacent teeth and structures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02283528
Brief Title
A Comparison of Stryker Hybrid Arch Bars
Acronym
Hybrid
Official Title
A Comparison of Stryker Hybrid Arch Bars Versus Erich Arch Bars for Maxillomandibular Fixation of Mandibular Fractures: A Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 21, 2017 (Actual)
Study Completion Date
December 21, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients who sustain a fracture of the lower jaw are typically treated by wiring the teeth together or using small titanium plates and screws to fix the fracture. With either technique the upper and lower teeth are held together to ensure that the fracture is held in the correct position during healing (for closed reduction) or while the plate and screws are applied (for open reduction).
The teeth can be held together using Erich arch bars which are a type of braces that are temporarily wired to the existing teeth. These stay in place for 6 weeks until the fracture has healed even though the patient is able to open his mouth immediately after the surgery is complete. The alternative to the traditional Erich arch bars is a relatively new type of arch bar (Stryker Hybrid) that is screwed to the jaw bone rather than wired to the teeth. The purpose of this study is to compare the two types of arch bars in terms of the speed with which they can be applied as well as any difference in fracture healing
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture Mandible
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hybrid
Arm Type
Experimental
Arm Description
Placement of Hybrid arch bars for open or closed reduction of mandible fractures
Arm Title
Erich
Arm Type
Active Comparator
Arm Description
Placement of Erich archbars for open or closed reduction of mandible fractures
Intervention Type
Device
Intervention Name(s)
Stryker Hybrid
Intervention Description
Place Hybrid arch bars
Intervention Type
Device
Intervention Name(s)
Erich
Intervention Description
Control group is Erich arch bars
Primary Outcome Measure Information:
Title
Time to Place Archbars
Description
Time taken to place archbars
Time Frame
During initial admission and surgery
Secondary Outcome Measure Information:
Title
Number of Participants With Fracture Healing at 6 Weeks
Description
Radiographic healing
Time Frame
6 weeks
Title
Number of Participants With Complications Including Loosening of Archbars, Loosening of MMF, or Damage to Adjacent Teeth and Structures
Description
assess operative and post-operative complications to include loosening of archbars, loosening of MMF if stratified to closed reduction and damage to adjacent teeth and structures
Time Frame
up to 6 weeks post operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mandible fracture involving subcondyle, ramus, angle, body, parasymphysis and symphysis
Age 18 years - 90 years
Ability to give informed consent
Minimum 6 weeks follow-up
Pre and post-operative panoramic xrays
Exclusion Criteria:
Comminuted fractures
Infected fractures
Previously treated fractures
Complete edentulism
Gun shot wounds
Pregnancy or breast feeding
Facility Information:
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
Country
United States
12. IPD Sharing Statement
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A Comparison of Stryker Hybrid Arch Bars
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