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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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 102
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Any adult patient (ages 18 and over) with a femoral shaft fracture that is treated with intramedullary nailing within 24 hours of presentation Exclusion Criteria: - Patients younger than 18 - Polytraumatized patients - Patients with pathological fractures - Patients with femoral shaft fracture not amenable to intramedullary nailing

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Skeletal traction
A pin through the bone with weights attached
Femoral shaft splinting
A splint of the broken thigh bone

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Chicago

Outcome

Type Measure Description Time frame Safety issue
Primary Time to reduce a femoral shaft fracture 1) To determine if the time to reduce a femoral shaft fracture is decreased in patients that receive preoperative traction Within 24 hours of presentation
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