Evaluating Femoral Traction

Evaluating Skeletal Traction for Patients With Femoral Shaft Fractures Treated With Intramedullary Nailing 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.

Study Overview

• Status: Terminated
• Conditions: Femoral Shaft Fracture
• Intervention / Treatment: Procedure: Skeletal traction; Procedure: Femoral shaft splinting

Detailed 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. Dr. 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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Local standard of care	Procedure: Skeletal traction; A pin through the bone with weights attached
Active Comparator: Experimental change in care	Procedure: Femoral shaft splinting; A splint of the broken thigh bone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to reduce a femoral shaft fracture	Time to reduce a femoral shaft fracture is decreased in patients that receive preoperative traction. Time measured in minutes. Short time means faster time to reduction.	Within 24 hours of presentation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in preoperative opiate requirement	To see if Patients that receive preoperative traction for a femoral shaft fracture have a change in preoperative opiate requirement as measured by morphine equivalents/kg/hr. More morphine means lower pain control.	24 hours from presentation
Change in transfusion requirement	To determine if patients that receive preoperative traction for a femoral shaft fracture have a change in transfusion requirement. Measured by total liters of blood given to patient during surgery.	Within 24 hours of presentation

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Anthony Christiano, MD, University of Chicago faculty

Publications and helpful links

General Publications

• Obey MR, Berkes MB, McAndrew CM, Miller AN. Lower-Extremity Skeletal Traction Following Orthopaedic Trauma: Indications, Techniques, and Evidence. JBJS Rev. 2019 Nov;7(11):e4. doi: 10.2106/JBJS.RVW.19.00032. No abstract available.
• Even JL, Richards JE, Crosby CG, Kregor PJ, Mitchell EJ, Jahangir AA, Tressler MA, Obremskey WT. Preoperative skeletal versus cutaneous traction for femoral shaft fractures treated within 24 hours. J Orthop Trauma. 2012 Oct;26(10):e177-82. doi: 10.1097/BOT.0b013e31823a8dae.

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2024
• Primary Completion (Actual): September 23, 2025
• Study Completion (Actual): September 23, 2025

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: November 29, 2023
• First Posted (Actual): December 7, 2023

Study Record Updates

• Last Update Posted (Estimated): October 16, 2025
• Last Update Submitted That Met QC Criteria: October 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures
• Other Study ID Numbers: IRB23-0183

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual patient data will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No