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| ID | Type | Description | Link |
|---|---|---|---|
| DDD# 602252 | Other Identifier | ChristianaCHS |
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Extended study duration
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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.
Purpose:
To identify which option of wiring the jaws together during treatment of mandible fractures is more cost effective to the patient, Erich arch bars or IMF (Intermaxillary Fixation) screws. Patients who sustain mandible fractures that meet the inclusion criteria will be randomized to one of the two treatment types listed above. The overall treatment in both categories is consistent with the standard of care, the only difference being the method utilized to achieve intermaxillary fixation during the course of the surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMF Screws | Active Comparator | Use of IMF screws as a means to wire the jaws. |
|
| Erich Arch Bars | Active Comparator | Use of Erich Arch bars in the wiring of the jaws. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMF Screws | Device | stainless steel screws placed in bone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time | Time duration for the application of device, in minutes. | Time duration of placement of device in operating room |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Meara, MD | Christiana Care Health Services | Principal Investigator |
| Daniel J Meara, MS, MD, DMD | Christiana Care Health Services | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christiana Care Hospital | Newark | Delaware | 19718 | United States | ||
| Wilmington Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | IMF Screws | Use of IMF screws as a means to wire the jaws. IMF Screws: stainless steel screws placed in bone |
| FG001 | Erich Arch Bars | Use of Erich Arch bars in the wiring of the jaws. Erich Arch Bars: Surgical braces wired around teeth |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intermaxillary Fixation Screws | Use of Intermaxillary Fixation screws as a means to wire the jaws. IMF Screws: stainless steel screws placed in bone |
| BG001 | Erich Arch Bars | Use of Erich Arch bars in the wiring of the jaws. Erich Arch Bars: Surgical braces wired around teeth |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time | Time duration for the application of device, in minutes. | Posted | Mean | Full Range | minutes | Time duration of placement of device in operating room |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IMF Screws | Use of IMF screws as a means to wire the jaws. IMF Screws: stainless steel screws placed in bone |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Department Chair | OMFS & HD | 302-320-6458 | dmeara@christianacare.org |
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| ID | Term |
|---|---|
| D008337 | Mandibular Fractures |
| ID | Term |
|---|---|
| D007572 | Jaw Fractures |
| D008446 | Maxillofacial Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
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| Erich Arch Bars | Device | Surgical braces wired around teeth |
|
| Wilmington |
| Delaware |
| 19801 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Duration to Maxillomandibular Fixation (minutes) | Mean | Full Range | minutes |
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| Participants |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Erich Arch Bars | Use of Erich Arch bars in the wiring of the jaws. Erich Arch Bars: Surgical braces wired around teeth | 0 | 3 | 0 | 3 |
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| D020196 |
| Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D012887 | Skull Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |