Skeletal Traction for Femur Fractures

Overseen By Olivia Keaveny

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Under 18, Polytrauma, Pathological fractures, others

Compensation: Varies

Number of Visits: 2

102 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Femoral shaft splinting, Skeletal traction for femur fractures?

Skeletal traction is shown to be an effective initial way to stabilize various orthopedic injuries, including femur fractures, as it helps keep the broken bone in the right position until surgery. It is often used temporarily to manage the injury and can be applied safely with a low risk of complications. ^{1 2 3 4 5}

Is skeletal traction generally safe for humans?

Skeletal traction is generally considered safe when performed by knowledgeable surgeons, with a low rate of complications. It is used to stabilize fractures and is not particularly painful for patients, although it may cause temporary muscle weakness. ^{1 2 3 6 7}

How does skeletal traction differ from other treatments for femur fractures?

Skeletal traction is unique because it stabilizes femur fractures by using pins inserted into the bone to apply a pulling force, which is especially useful in resource-limited or austere environments. Unlike other treatments, it can be used both temporarily and as a definitive solution, and it helps reduce complications and hospital stay compared to conventional methods. ^{1 2 6 8 9}

What is the purpose of this trial?

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.

Research Team

Anthony Christiano, MD

Principal Investigator

University of Chicago faculty

Eligibility Criteria

Adults over 18 with a femoral shaft fracture who are scheduled for intramedullary nailing within 24 hours of the injury can participate. The trial is not suitable for those who don't meet these specific conditions.

Inclusion Criteria

I am an adult who had surgery with a metal rod for a thigh bone fracture within 24 hours of injury.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative Traction

Participants receive preoperative skeletal traction or splinting for femoral shaft fractures

Within 24 hours of presentation

1 visit (in-person)

Surgery

Participants undergo intramedullary nailing for femoral shaft fractures

Within 24 hours of presentation

1 visit (in-person)

Follow-up

Participants are monitored for surgical outcomes, pain control, and blood loss

4 weeks

Treatment Details

Interventions

• Femoral shaft splinting
• Skeletal traction

Trial Overview The study compares two methods: skeletal traction and femoral shaft splinting, to see which one helps reduce surgery time, controls pain better, and decreases blood loss in patients with femur fractures.

Participant Groups

Group I: Experimental change in care Active Control 1 Intervention

Group II: Local standard of care Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Proximal Tibia Skeletal Traction: Technique and Indications. [2021]

2. China pubmed.ncbi.nlm.nih.gov

[Effect of preoperative skeletal traction and skin traction on operative indicators and functional outcome of patients with femur fractures]. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Preoperative skeletal versus cutaneous traction for femoral shaft fractures treated within 24 hours. [2012]

4. Ghana pubmed.ncbi.nlm.nih.gov

A comparative evaluation of the efficacy between skeletal traction and skin traction in pre-operative management of femur shaft fractures in Korle Bu Teaching Hospital. [2022]

5. Belgium pubmed.ncbi.nlm.nih.gov

The effect of skeletal traction on femoral neck fractures. [2004]

6. France pubmed.ncbi.nlm.nih.gov

Rectus femoris muscle atrophy and recovery caused by preoperative pretibial traction in femoral shaft fractures-comparison between traction period. [2018]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Preoperative traction in patients with hip fractures. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

A Skeletal Traction Technique for Proximal Femur Fracture Management in an Austere Environment. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Closed femoral fractures: why not simple traction? [2019]