Trial Outcomes & Findings for A Comparison of Stryker Hybrid Arch Bars (NCT NCT02283528)

NCT ID: NCT02283528

Last Updated: 2019-01-14

Results Overview

Time taken to place archbars

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: During initial admission and surgery
• Results posted on: 2019-01-14

Participant Flow

Participant milestones

Measure	Hybrid Placement of Hybrid arch bars for open or closed reduction of mandible fractures Stryker Hybrid: Place Hybrid arch bars	Erich Placement of Erich archbars for open or closed reduction of mandible fractures Erich: Control group is Erich arch bars
Overall Study STARTED	26	24
Overall Study COMPLETED	26	24
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Comparison of Stryker Hybrid Arch Bars

Baseline characteristics by cohort

Measure	Hybrid n=26 Participants Placement of Hybrid arch bars for open or closed reduction of mandible fractures Stryker Hybrid: Place Hybrid arch bars	Erich n=24 Participants Placement of Erich archbars for open or closed reduction of mandible fractures Erich: Control group is Erich arch bars	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants	24 Participants n=7 Participants	50 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	21 Participants n=5 Participants	17 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants	24 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: During initial admission and surgery

Time taken to place archbars

Outcome measures

Measure	Hybrid n=26 Participants Placement of Hybrid arch bars for open or closed reduction of mandible fractures Stryker Hybrid: Place Hybrid arch bars	Erich n=24 Participants Placement of Erich archbars for open or closed reduction of mandible fractures Erich: Control group is Erich arch bars
Time to Place Archbars	14.07 minutes Standard Deviation 8.4	37.29 minutes Standard Deviation 15.1

SECONDARY outcome

Timeframe: 6 weeks

Radiographic healing

Outcome measures

Measure	Hybrid n=26 Participants Placement of Hybrid arch bars for open or closed reduction of mandible fractures Stryker Hybrid: Place Hybrid arch bars	Erich n=24 Participants Placement of Erich archbars for open or closed reduction of mandible fractures Erich: Control group is Erich arch bars
Number of Participants With Fracture Healing at 6 Weeks	18 Participants	18 Participants

SECONDARY outcome

Timeframe: up to 6 weeks post operatively

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

Outcome measures

Measure	Hybrid n=26 Participants Placement of Hybrid arch bars for open or closed reduction of mandible fractures Stryker Hybrid: Place Hybrid arch bars	Erich n=24 Participants Placement of Erich archbars for open or closed reduction of mandible fractures Erich: Control group is Erich arch bars
Number of Participants With Complications Including Loosening of Archbars, Loosening of MMF, or Damage to Adjacent Teeth and Structures	5 Participants	0 Participants

Adverse Events

Hybrid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Erich

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gary Francis Bouloux

Emory University

Phone: 404-778-4500

Email: gfboulo@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place