Femur Fracture
Conditions
Keywords
Pre-operative Traction, Traction, Proximal Femur Fracture, Femoral Fractures, Femoral Fracture, Skeletal Traction, Cutaneous Traction
Brief summary
The purpose of this study is to determine whether there are any differences in skeletal or cutaneous traction for the treatment of femur fractures.
Detailed description
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.
Interventions
PROCEDUREFemoral Traction
Femoral Traction is a temporary intervention to realign the broken bone and help relieve pressure and muscle spasms until operative fixation.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient willing to consent * 18 years of age or older * Sustained a diaphyseal femur fracture, open or closed * English competent * Isolated fracture on that extremity
Exclusion criteria
* Pathologic fracture * Sedated patient * Polytrauma to same extremity * Unable or not willing to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the Two Groups in Regards to Resident Time. | while in Emergency Department (ED) up to 24 hours | Time from consult entered to time traction apparatus is applied. |
| Time to Pass Guidewire After Attaining Starting Point | while in Emergency Department (ED) up to 24 hours | Time to pass guidewire across reduced fracture once opening reamer is used in OR |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 37 |
| 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. | 29 |
| Total | 66 |
Baseline characteristics
| Characteristic | Skeletal Traction | Cutaneous Traction | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 37 Participants | 66 Participants |
| Age, Continuous | 28.0 years STANDARD_DEVIATION 13.5 | 25.6 years STANDARD_DEVIATION 12.75 | 27 years STANDARD_DEVIATION 13.1 |
| Region of Enrollment United States | 29 participants | 37 participants | 66 participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Male | 24 Participants | 30 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 37 | 0 / 29 |
| serious Total, serious adverse events | 1 / 37 | 0 / 29 |
Outcome results
Primary
Difference in the Two Groups in Regards to Resident Time.
Time from consult entered to time traction apparatus is applied.
Time frame: while in Emergency Department (ED) up to 24 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cutaneous Traction | Difference in the Two Groups in Regards to Resident Time. | 24 minutes |
| Skeletal Traction | Difference in the Two Groups in Regards to Resident Time. | 57 minutes |
Primary
Time to Pass Guidewire After Attaining Starting Point
Time to pass guidewire across reduced fracture once opening reamer is used in OR
Time frame: while in Emergency Department (ED) up to 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cutaneous Traction | Time to Pass Guidewire After Attaining Starting Point | 15 minutes | Standard Deviation 24 |
| Skeletal Traction | Time to Pass Guidewire After Attaining Starting Point | 18 minutes | Standard Deviation 17 |