Trial Outcomes & Findings for Skeletal Versus Cutaneous Traction For Treatment of Femur Fractures (NCT NCT00916136)

Results Overview

Time from consult entered to time traction apparatus is applied.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

66 participants

Primary outcome timeframe

while in Emergency Department (ED) up to 24 hours

Results posted on

2017-05-30

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	37	29
Overall Study COMPLETED	37	29
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Skeletal Versus Cutaneous Traction For Treatment of Femur Fractures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cutaneous Traction n=37 Participants 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.	Skeletal Traction n=29 Participants 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.	Total n=66 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=5 Participants	29 Participants n=7 Participants	66 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	25.6 years STANDARD_DEVIATION 12.75 • n=5 Participants	28.0 years STANDARD_DEVIATION 13.5 • n=7 Participants	27 years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	24 Participants n=7 Participants	54 Participants n=5 Participants
Region of Enrollment United States	37 participants n=5 Participants	29 participants n=7 Participants	66 participants n=5 Participants

PRIMARY outcome

Timeframe: while in Emergency Department (ED) up to 24 hours

Time from consult entered to time traction apparatus is applied.

Outcome measures

Outcome measures
Measure	Cutaneous Traction n=37 Participants 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.	Skeletal Traction n=29 Participants 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.
Difference in the Two Groups in Regards to Resident Time.	24 minutes Interval 12.0 to 50.0	57 minutes Interval 40.0 to 80.0

PRIMARY outcome

Timeframe: while in Emergency Department (ED) up to 24 hours

Time to pass guidewire across reduced fracture once opening reamer is used in OR

Outcome measures

Outcome measures
Measure	Cutaneous Traction n=37 Participants 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.	Skeletal Traction n=29 Participants 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.
Time to Pass Guidewire After Attaining Starting Point	15 minutes Standard Deviation 24	18 minutes Standard Deviation 17

Adverse Events

Cutaneous Traction

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Skeletal Traction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cutaneous Traction n=37 participants at risk 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.	Skeletal Traction n=29 participants at risk 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.
Skin and subcutaneous tissue disorders Foot numbness	2.7% 1/37 • Number of events 1	0.00% 0/29

Other adverse events

Adverse event data not reported

Additional Information

William Obremskey MD MPH

Vanderbilt

Phone: 615-936-0112

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place