Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06160804 |
| Other study ID # |
IRB23-0183 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2023 |
| Est. completion date |
December 31, 2025 |
Study information
| Verified date |
November 2023 |
| Source |
University of Chicago |
| Contact |
Olivia Keaveny |
| Phone |
773-834-8994 |
| Email |
okeaveny[@]bsd.uchicago.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The primary goal of this study is to test the hypothesis that skeletal traction allows for
easier intraoperative reduction time by comparing the reduction time in patients that receive
skeletal traction for femoral shaft fracture to those that do not. Secondary goals are to
assess the claims of improved pain control and decreased blood loss in patients that receive
skeletal traction for femoral shaft fracture to those that do not.
Description:
Traction is a practice dating back thousands of years, historically used for the definitive
treatment of femoral shaft fractures. With advances in surgical care, traction is no longer
regularly used for definitive treatment. However, traction is commonly used preoperatively
with the claimed benefits of fracture stabilization allowing for improved pain control,
restoration of limb length with easier operative reduction, and controlling bleeding by
decreasing compartmental volume. However, studies have begun to question the utility of
skeletal traction in patients with femoral shaft fractures.
While pre-hospital traction splints may provide added pain control for patients with femoral
shaft fractures as they are transported to the hospital, skeletal traction may not provide
the same pain control benefits in the inpatient setting. Bumpass and colleagues prospectively
compared patients with femoral shaft fractures placed into distal femoral traction to those
that were splinted. The authors demonstrated that while patients that were splinted reported
higher pain scores during application, pain scores after immobilization were not different
between the two groups.
Retrospective and prospective investigations of traction for femoral shaft fractures have
failed to demonstrate easier operative reduction or decreased blood loss. Koerner et al
retrospectively evaluated patients with femoral shaft fractures that underwent definitive
intramedullary nailing within 24 hours of presentation. The authors demonstrated no
difference in blood loss, transfusion requirement, or need for open reduction between
patients placed in skeletal traction and patients placed in lower extremity splints.
Similarly, in their randomized controlled trial Even et al demonstrated no difference in
reduction time for patients with femoral shaft fractures fixed within 24 hours that received
skeletal traction or skin traction preoperatively.
To the investigator's knowledge, no study has prospectively compared surgical time, pain
control, and blood loss for patients that receive preoperative skeletal traction to splinting
for femoral shaft fractures that receive intramedullary nailing within 24 hours of
presentation.
Skeletal traction has a long history in orthopaedic surgery for the treatment of femoral
shaft fractures, but may be unnecessary for patients that are surgically treated within 24
hours of presentation. The primary goal of this study is to test the hypothesis that skeletal
traction allows for easier intraoperative reduction time by comparing the reduction time in
patients that receive skeletal traction for femoral shaft fracture to those that do not.
Secondary goals are to assess the claims of improved pain control and decreased blood loss in
patients that receive skeletal traction for femoral shaft fracture to those that do not.
