Trial Outcomes & Findings for Arch Bars vs. IMF (Intermaxillary Fixation) Screws: Cost Effectiveness Based on Time Duration of Device Placement. (NCT NCT01876979)
NCT ID: NCT01876979
Last Updated: 2017-06-28
Results Overview
Time duration for the application of device, in minutes.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
Time duration of placement of device in operating room
Results posted on
2017-06-28
Participant Flow
Participant milestones
| Measure |
IMF Screws
Use of IMF screws as a means to wire the jaws.
IMF Screws: stainless steel screws placed in bone
|
Erich Arch Bars
Use of Erich Arch bars in the wiring of the jaws.
Erich Arch Bars: Surgical braces wired around teeth
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
IMF Screws
Use of IMF screws as a means to wire the jaws.
IMF Screws: stainless steel screws placed in bone
|
Erich Arch Bars
Use of Erich Arch bars in the wiring of the jaws.
Erich Arch Bars: Surgical braces wired around teeth
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
3
|
Baseline Characteristics
Arch Bars vs. IMF (Intermaxillary Fixation) Screws: Cost Effectiveness Based on Time Duration of Device Placement.
Baseline characteristics by cohort
| Measure |
Intermaxillary Fixation Screws
n=2 Participants
Use of Intermaxillary Fixation screws as a means to wire the jaws.
IMF Screws: stainless steel screws placed in bone
|
Erich Arch Bars
n=3 Participants
Use of Erich Arch bars in the wiring of the jaws.
Erich Arch Bars: Surgical braces wired around teeth
|
Total
n=5 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
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Duration to Maxillomandibular Fixation (minutes)
|
17 minutes
n=5 Participants
|
40.3 minutes
n=7 Participants
|
28.7 minutes
n=5 Participants
|
PRIMARY outcome
Timeframe: Time duration of placement of device in operating roomTime duration for the application of device, in minutes.
Outcome measures
| Measure |
IMF Screws
n=2 Participants
Use of IMF screws as a means to wire the jaws.
IMF Screws: stainless steel screws placed in bone
|
Erich Arch Bars
n=3 Participants
Use of Erich Arch bars in the wiring of the jaws.
Erich Arch Bars: Surgical braces wired around teeth
|
|---|---|---|
|
Time
|
17 minutes
Interval 11.0 to 23.0
|
40.3 minutes
Interval 35.0 to 50.0
|
Adverse Events
IMF Screws
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Erich Arch Bars
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place