A Comparison of Stryker Hybrid Arch Bars

Fracture Mandible Clinical Trial

— Hybrid  

Official title:

A Comparison of Stryker Hybrid Arch Bars Versus Erich Arch Bars for Maxillomandibular Fixation of Mandibular Fractures: A Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02283528
• Other study ID #: IRB00076048
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: December 21, 2017

Study information

• Verified date: January 2019
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 21, 2017
• Est. primary completion date: December 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Mandible fracture involving subcondyle, ramus, angle, body, parasymphysis and symphysis

2. Age 18 years - 90 years

3. Ability to give informed consent

4. Minimum 6 weeks follow-up

5. Pre and post-operative panoramic xrays

Exclusion Criteria:

1. Comminuted fractures

2. Infected fractures

3. Previously treated fractures

4. Complete edentulism

5. Gun shot wounds

6. Pregnancy or breast feeding

Related Conditions & MeSH terms

• Fracture Mandible
• Mandibular Fractures

Intervention

Device:
• Stryker Hybrid
Place Hybrid arch bars
• Erich
Control group is Erich arch bars

Locations

Country	Name	City	State
United States	Grady Memorial Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Place Archbars	Time taken to place archbars	During initial admission and surgery
Secondary	Number of Participants With Fracture Healing at 6 Weeks	Radiographic healing	6 weeks
Secondary	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	up to 6 weeks post operatively