Femoral Shaft Fracture
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICETRIGEN SURESHOT Distal Targeting Instrumentation.
image-guided localization system
OTHERFree-hand technique
Free-hand technique utilizes x-rays to find screw holes.
Sponsors
Smith & Nephew, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Unilateral femoral shaft fracture requiring intramedullary nailing in which the use of stereotactic surgery may be appropriate. * Subject is between 18-80 years of age. * Subject is skeletally mature * Subject is of legal age and capable of providing legal consent. * Subject is suitable for current Intramedullary Nailing procedure * Subject willing to accept randomization either to the TRIGEN SURESHOT Distal Targeting System or TRIGEN standard instrumentation.
Exclusion criteria
* Femur shaft fracture not amenable to intramedullary nailing in which the use of sterotactic surgery may be inappropriate. * Fracture with vascular injury (Gustilo Type IIIC) requiring repair * Open fractures where open wound is in communication with distal targeting holes and therefore would influence duration of locking procedure (i.e. potentially no need for incisions for locking screw placement). * Fracture of the Metaphyseal distal femur with intraarticular comminution * Known Pathological Fracture * Subject is a prisoner * Operative procedure for closed fracture is scheduled for greater than 2 weeks for closed fractures * Subject has cognitive issue/mental status conditions that preclude intramedullary nailing in the judgment of the investigator. * Contralateral femoral shaft fracture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiation Exposure Measurement | Intraoperative | Radiation exposure measured in two ways: Whole body badge TLD ring badge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distal Locking Time | Intraoperative | Distal locking time is defined as the period between successful nail insertion without locking and the confirmation of accurate insertion of both distal screws. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TRIGEN SURESHOT Distal Targeting TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.
TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system | 30 |
| 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. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | TRIGEN SURESHOT Distal Targeting | Standard Nailing Instrumentation. | Total |
|---|---|---|---|
| Age, Continuous | 37.7 Years STANDARD_DEVIATION 19 | 35.3 Years STANDARD_DEVIATION 19.5 | 36.5 Years STANDARD_DEVIATION 19.1 |
| Sex: Female, Male Female | 7 Participants | 10 Participants | 17 Participants |
| Sex: Female, Male Male | 23 Participants | 20 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Radiation Exposure Measurement
Radiation exposure measured in two ways: Whole body badge TLD ring badge
Time frame: Intraoperative
Population: Primary endpoint voided. Dosimeters did not capture radiation dose as expected.
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.
Time frame: Intraoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TRIGEN SURESHOT Distal Targeting | Distal Locking Time | 12.6 minutes | Standard Deviation 6.9 |
| Standard Nailing Instrumentation. | Distal Locking Time | 14.7 minutes | Standard Deviation 8.4 |