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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of skeletal traction, a method where weights pull on the leg, in treating femur (thigh bone) fractures. It aims to determine if this method simplifies and speeds up surgery. The trial will also assess whether it aids in pain relief and reduces blood loss during surgery. Participants should be adults with a femoral shaft fracture scheduled for surgery within 24 hours. As an unphased trial, it provides a unique opportunity to contribute to medical knowledge and potentially enhance treatment for future patients.

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 prior data suggests that skeletal traction is safe for femur fractures?

Research has shown that skeletal traction is generally safe for treating broken thigh bones (femur fractures). One study found that applying traction to the lower part of the thigh bone helps relieve pain and is considered safe. However, this study did not include information on using traction for other bones like the shinbone (tibia) or heel. Another study examined different traction methods and found they help with pain relief for thigh bone fractures.

These studies suggest that patients tolerate skeletal traction well, with no serious safety concerns reported. While every medical treatment can have risks, current evidence supports skeletal traction as a safe option for managing thigh bone fractures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard approach for femur fractures, which often involves surgical intervention with internal fixation techniques like rods, plates, or screws, skeletal traction offers a non-surgical option. Researchers are excited about skeletal traction because it uses a pulley system to align and stabilize the broken bone using weights, which can reduce the need for invasive surgery. This method could potentially minimize surgical risks and complications, providing a safer alternative for patients who are not ideal candidates for surgery. Additionally, skeletal traction might be more cost-effective and accessible, especially in settings with limited surgical resources.

What evidence suggests that skeletal traction is effective for femur fractures?

Studies have shown that skeletal traction, one of the treatments evaluated in this trial, effectively stabilizes broken thigh bones (femur fractures). It keeps the broken bone in place, which can make the surgery to fix it smoother. Research indicates that skeletal traction and another method, called skin traction, are equally effective at reducing pain before surgery for these fractures. Additionally, a review of studies suggests that while skeletal traction is helpful, switching to a different treatment called intramedullary nailing (IMN) might save money in the long run. Overall, skeletal traction is a proven method for managing femur fractures, making surgery easier and potentially less painful. ^{2 6 7 8 9}

Who Is on the Research Team?

Anthony Christiano, MD

Principal Investigator

University of Chicago faculty

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8042791/

A comparative evaluation of the efficacy between skeletal ... This study has shown that both Skeletal traction and Skin traction were equally effective in controlling pre-operative pain in adult patients with femoral shaft ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8023961/

Outcome at 1 year in patients with femoral shaft fractures ... This prospective study compared patient-reported quality of life and functional status after femoral shaft fractures treated with IMN or ST in Malawi.

3. withpower.com withpower.com/trial/phase-femoral-fractures-11-2023-026f7

Skeletal Traction for Femur Fractures · Info for Participants 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 ...

4. gh.bmj.com gh.bmj.com/content/2/3/e000313

A systematic review of cost-effectiveness, comparing ... The objective herein was to evaluate the cost-effectiveness of moving from traction to IM nailing for femoral shaft fractures, in adults, in ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1878124123000084

The use of skin traction in the adult patients with proximal ... The research question was: which are the effects of skin traction, its advantages and disadvantages in adult patients with proximal femur fractures hospitalised ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11519418/

Pre-Operative Traction in Femoral Fractures for Pain ... This meta-analysis studies and assesses the pain relief effect of different pre-operative traction systems in proximal and femoral shaft fractures.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0020138322007161

Traction Splinting for midshaft femoral fractures in the pre- ... Prehospital deaths due to femoral shaft fractures were reported to occur at a rate of 3.5 per 100,000 people [2].

8. archtrauma.kaums.ac.ir archtrauma.kaums.ac.ir/article_119114.html

Safety of skeletal traction through the distal femur, proximal ... Recent literature suggests that distal femoral traction provides pain relief and is safe; however, data regarding proximal tibial and calcaneal pins are ...

9. ota.org ota.org/sites/files/2021-06/LE%20Hip5%20Femoral%20Shaft%20Fractures.pdf

Femoral Shaft Fractures “Our data show that early femur fracture fixation (< 24 hours) is associated with an improved outcome, even in patients with coexistent head and/or chest ...