Evaluating Femoral Traction

NCT ID: NCT06160804

Last Updated: 2025-10-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-19
• Study Completion Date: 2025-09-23

Brief 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.

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.

Conditions

Femoral Shaft Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Local standard of care

Group Type: PLACEBO_COMPARATOR

Skeletal traction

Intervention Type: PROCEDURE

A pin through the bone with weights attached

Experimental change in care

Group Type: ACTIVE_COMPARATOR

Femoral shaft splinting

Intervention Type: PROCEDURE

A splint of the broken thigh bone

Interventions

Skeletal traction

A pin through the bone with weights attached

Intervention Type: PROCEDURE

Femoral shaft splinting

A splint of the broken thigh bone

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony Christiano, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago faculty

Locations

University of Chicago

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 31764196 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22430522 (View on PubMed)

Other Identifiers

IRB23-0183

Identifier Type: -

Identifier Source: org_study_id