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The purpose of this study is to determine whether there are any differences in skeletal or cutaneous traction for the treatment of femur fractures.
Diaphyseal femur fractures are a common occurrence in busy level one trauma centers and even in the age of damage control orthopaedics most of these fractures are fixed definitively within 24 hours. The historical method of temporizing these fractures has been to place a distal femoral or proximal tibial skeletal traction pin. However, in the pediatric population skeletal traction is not utilized due to concern for physeal injury and cutaneous traction has been the gold standard for decades. Reasons for skeletal traction in adults are not well defined and there are no clinical studies showing that skeletal traction provides better outcomes in time of reduction in the operating theater or better pain control than cutaneous traction. With the ever increasing amount of high energy trauma seen by junior residents in the emergency department time constraints have become a large factor in patient care. Long delays for sedation and equipment procurement make stabilizing a diaphyseal femur fracture a time consuming experience. The purpose of this study is to determine whether differences exist between skeletal and cutaneous femoral traction in terms of: 1) time in patient consultation and fracture stabilization; 2) cost and risk to the patient due to lack of conscious sedation; 3) pain scores prior to surgery; 4) time of reduction of the diaphyseal femur fraction during surgical fixation; and 5) pain relief after traction application.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cutaneous Traction | Active Comparator | Applied by using a strap on boot that attaches to the leg. A rope is attached to the boot. Weight is attached to the rope to use gravity to pull traction. The traction is left in place until patient is taken to surgery for reduction of the femur fracture. |
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| Skeletal Traction | Active Comparator | A small incision is made on the inside of the knee and a pin is surgically inserted through the bone. Weights are then attached that will pull traction on the broken femur. This traction pin will stay in until patient is taken to surgery for reduction of the femur fracture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Femoral Traction | Procedure | Femoral Traction is a temporary intervention to realign the broken bone and help relieve pressure and muscle spasms until operative fixation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the Two Groups in Regards to Resident Time. | Time from consult entered to time traction apparatus is applied. | while in Emergency Department (ED) up to 24 hours |
| Time to Pass Guidewire After Attaining Starting Point | Time to pass guidewire across reduced fracture once opening reamer is used in OR | while in Emergency Department (ED) up to 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jesse L Even, MD | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16855952 | Background | Parker MJ, Handoll HH. Pre-operative traction for fractures of the proximal femur in adults. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD000168. doi: 10.1002/14651858.CD000168.pub2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cutaneous Traction | Applied by using a strap on boot that attaches to the leg. A rope is attached to the boot. Weight is attached to the rope to use gravity to pull traction. The traction is left in place until patient is taken to surgery for reduction of the femur fracture. |
| FG001 | Skeletal Traction | A small incision is made on the inside of the knee and a pin is surgically inserted through the bone. Weights are then attached that will pull traction on the broken femur. This traction pin will stay in until patient is taken to surgery for reduction of the femur fracture. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cutaneous Traction | Applied by using a strap on boot that attaches to the leg. A rope is attached to the boot. Weight is attached to the rope to use gravity to pull traction. The traction is left in place until patient is taken to surgery for reduction of the femur fracture. |
| BG001 | Skeletal Traction |
| 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 | Difference in the Two Groups in Regards to Resident Time. | Time from consult entered to time traction apparatus is applied. | Posted | Mean | 95% Confidence Interval | minutes | while in Emergency Department (ED) up to 24 hours |
|
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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 | Cutaneous Traction | Applied by using a strap on boot that attaches to the leg. A rope is attached to the boot. Weight is attached to the rope to use gravity to pull traction. The traction is left in place until patient is taken to surgery for reduction of the femur fracture. Femoral Traction: Temporary intervention to realign the broken bone and help relieve pressure and muscle spasms until operative fixation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Foot numbness | Skin and subcutaneous tissue disorders | Systematic Assessment | Foot was numb for 1 day after boot traction applied. Numbness completely resolved |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Obremskey MD MPH | Vanderbilt | 615-936-0112 | william.obremskey@vanderbilt.edu |
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| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D000092526 | Proximal Femoral Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
| D005265 | Femoral Neck Fractures |
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|
A small incision is made on the inside of the knee and a pin is surgically inserted through the bone. Weights are then attached that will pull traction on the broken femur. This traction pin will stay in until patient is taken to surgery for reduction of the femur fracture. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
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| Primary | Time to Pass Guidewire After Attaining Starting Point | Time to pass guidewire across reduced fracture once opening reamer is used in OR | Posted | Mean | Standard Deviation | minutes | while in Emergency Department (ED) up to 24 hours |
|
|
|
| 1 |
| 37 |
| 0 |
| 37 |
| EG001 | Skeletal Traction | A small incision is made on the inside of the knee and a pin is surgically inserted through the bone. Weights are then attached that will pull traction on the broken femur. This traction pin will stay in until patient is taken to surgery for reduction of the femur fracture. Femoral Traction: Temporary intervention to realign the broken bone and help relieve pressure and muscle spasms until operative fixation. | 0 | 29 | 0 | 29 |
|
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| D006620 |
| Hip Fractures |
| D025981 | Hip Injuries |