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Primary endpoint voided. Dosimeters did not capture radiation dose as expected.
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The objective of this study is to quantitate the amount of radiation both subjects and surgeons are exposed to during intramedullary nailing of the femur using the TRIGEN SURESHOT Distal Targeting System versus Standard nailing instrumentation.
The TRIGEN SURESHOT™ Distal Targeting System was designed to be an intraoperative image-guided localization system to aid with drill positioning for screws during intramedullary nailing distal interlocking. It is hypothesized that this system will aid in identification of the distal holes leading to reduced exposure to radiation. The SURESHOT System provides information to the surgeon that is used to place surgical instruments utilizing electromagnetic tracking data obtained intraoperatively. It is indicated for long bone fractures treated with intramedullary nailing in which the use of stereotactic surgery may be appropriate. The hypothesis is that using the TRIGEN SURESHOT™ Distal Targeting System will allow accurate distal locking while effectively decreasing the amount of radiation exposure compared to the standard instrumentation process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRIGEN SURESHOT Distal Targeting | Experimental | TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes. |
|
| Standard Nailing Instrumentation. | Active Comparator | Free-hand technique utilizes x-rays to find screw holes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRIGEN SURESHOT Distal Targeting Instrumentation. | Device | image-guided localization system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiation Exposure Measurement | Radiation exposure measured in two ways: Whole body badge TLD ring badge | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Distal Locking Time | Distal locking time is defined as the period between successful nail insertion without locking and the confirmation of accurate insertion of both distal screws. | Intraoperative |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Samir Mehta, M.D. | Orthopaedic Surgery, Hospital of the University of Pennsylvania | Principal Investigator |
| Animesh Agarwal, M.D. | UT Health Science Center, Dept of Orthopaedic | Principal Investigator |
| Marcus Sciadini, M.D | University of Maryland Baltimore, Department of Orthopaedics | Principal Investigator |
| Steven Olson, M.D. | Duke University Medical Center of Orthopaedic | Principal Investigator |
| Chad Coles, M.D. | Nova Scotia Health Authority | Principal Investigator |
| Richard Vlasak, M.D. | Dept. of Orthopaedics & Rehab University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Medical Center | Sacramento | California | 95817 | United States | ||
| Department of Orthopaedics and Rehabilitation |
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| ID | Title | Description |
|---|---|---|
| FG000 | TRIGEN SURESHOT Distal Targeting | TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes. TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system |
| FG001 | Standard Nailing Instrumentation. | Free-hand technique utilizes x-rays to find screw holes Free-hand technique: Free-hand technique utilizes x-rays to find screw holes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Unilateral femoral shaft fracture requiring treatment with intramedullary nails, in which the use of sterotactic surgery may be appropriate.
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| ID | Title | Description |
|---|---|---|
| BG000 | TRIGEN SURESHOT Distal Targeting | TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes. TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system |
| BG001 | Standard Nailing Instrumentation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Radiation Exposure Measurement | Radiation exposure measured in two ways: Whole body badge TLD ring badge | Primary endpoint voided. Dosimeters did not capture radiation dose as expected. | Posted | Intraoperative |
|
Operative and immediate postoperative
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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 | TRIGEN SURESHOT Distal Targeting | TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes. TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Change out screw | Surgical and medical procedures | Non-systematic Assessment | Change out distal locking screw |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cathy Newbill | Smith & Nephew, Inc. | 800-821-5700 | cathy.newbill@smith-nephew.com |
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| Free-hand technique | Other | Free-hand technique utilizes x-rays to find screw holes. |
|
| Gainesville |
| Florida |
| 32607 |
| United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Duke University Medical Center | Durham | North Carolina | 27707 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University Hospital Trauma Service | San Antonio | Texas | 78229 | United States |
| Capital District Health Authority | Halifax | Nova Scotia | Canada |
Free-hand technique utilizes x-rays to find screw holes Free-hand technique: Free-hand technique utilizes x-rays to find screw holes. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Distal Locking Time | Distal locking time is defined as the period between successful nail insertion without locking and the confirmation of accurate insertion of both distal screws. | Posted | Mean | Standard Deviation | minutes | Intraoperative |
|
|
|
| 0 |
| 30 |
| 4 |
| 30 |
| EG001 | Standard Nailing Instrumentation. | Free-hand technique utilizes x-rays to find screw holes Free-hand technique: Free-hand technique utilizes x-rays to find screw holes. | 0 | 30 | 0 | 30 |
|
| Probe misplacement | Surgical and medical procedures | Non-systematic Assessment | Probe not correctly placed |
|