Evaluating Femoral Traction

NCT06160804 | Terminated

• 1 other identifier: IRB23-0183
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoral Shaft Fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in preoperative opiate requirement

  24 hours from presentation

• Change in transfusion requirement

  Within 24 hours of presentation

Study Arms (2)

Local standard of care

PLACEBO COMPARATOR

Procedure: Skeletal traction

Experimental change in care

ACTIVE COMPARATOR

Procedure: Femoral shaft splinting

Interventions

Skeletal traction PROCEDURE

A pin through the bone with weights attached

Local standard of care

Femoral shaft splinting PROCEDURE

A splint of the broken thigh bone

Experimental change in care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any adult patient (ages 18 and over) with a femoral shaft fracture that is treated with intramedullary nailing within 24 hours of presentation

You may not qualify if:

• Patients younger than 18
• Polytraumatized patients
• Patients with pathological fractures
• Patients with femoral shaft fracture not amenable to intramedullary nailing

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (2)

• 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.

  PMID: 31764196 BACKGROUND

• 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.

  PMID: 22430522 BACKGROUND

Study Officials

• Anthony Christiano, MD

  University of Chicago faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial. Subgroups will be determined using equal block randomization. Block randomization will be used for this study. Blocks will be set to groups of 4 with each block of 4 comprising 2 traction and 2 splint opaque envelopes in random order. The envelope will be stored in the office of the principle investigator and opened following subject enrollment. This ensures subjects are blinded to their initial treatment modality. Standard of care will be followed for all clinical decisions beyond the type of stabilization procedure to be used.

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: March 19, 2024
• Primary Completion: September 23, 2025
• Study Completion: September 23, 2025
• Last Updated: October 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)