What is the mechanism of action of this treatment?

The most common treatments for femur fractures, particularly distal femur or femoral shaft fractures, involve internal fixation methods such as retrograde femoral nailing. This technique involves inserting a metal rod (nail) into the femur from the knee upwards, which is then secured with screws to stabilize the bone fragments. The RFN-advanced Retrograde Femoral Nailing System aims to improve alignment and reduce complications such as malalignment and non-union by providing a more stable and precise fixation. This is crucial for patients as it promotes proper healing, reduces pain, and enhances functional recovery, ultimately leading to better long-term outcomes.

What side effects are associated with this type of intervention?

The most common side effects of treatments for femur fractures, particularly with retrograde femoral nailing systems like the RFN-advanced, include malalignment, hip pain, thigh pain, and knee pain. Additionally, patients may experience general surgical complications such as infection, delayed healing, and hardware failure. These side effects highlight the importance of evaluating novel systems to improve alignment and reduce complications in the management of distal femur or femoral shaft fractures.

What prior FDA approvals exist?

The FDA has approved various internal fixation devices for the treatment of femur fractures, including retrograde femoral nailing systems and fixed-angle blade plates. These devices are designed to provide stable fixation for distal femur and femoral shaft fractures, aiming to improve alignment and reduce complications such as malalignment. Retrograde femoral nails are inserted through the knee and are particularly useful for distal femur fractures, while fixed-angle blade plates offer an alternative method of stabilization. Both types of devices have been shown to give good outcomes, although there may be differences in pain levels and the need for revision surgery.

What other types of research exist?

Promising novel alternatives to the RFN-advanced Retrograde Femoral Nailing System for femur fractures include: 1) Magnetic Compression Nails (MCNs) which use magnetic forces to enhance bone healing and alignment, 2) Biodegradable Intramedullary Nails that gradually dissolve and reduce the need for secondary surgeries, and 3) Smart Implants with embedded sensors to monitor healing and provide real-time data to clinicians. These alternatives aim to improve patient outcomes by addressing common complications associated with traditional fixation methods.

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Implant

Retrograde Femoral Nail for Broken Bones

N/A

Recruiting

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new type of metal rod implant for fixing broken thigh bones in adults. The goal is to see if this new design helps bones heal better and reduces complications compared to current treatments. Data on healing, function, and pain will be collected over time to evaluate its effectiveness.

Who is the study for?

Adults 18+ with a distal femur or femoral shaft fracture needing surgery can join this trial. They must be treated at UCSD, understand and consent to the study. Excluded are pregnant women, those in other drug studies within the last month, prisoners, and patients with severe diseases not under control.

What is being tested?

The RFN-Advanced Retrograde Femoral Nailing System is being tested for fixing fractures of the lower thigh bone. The study will track how well it works over three years by looking at healing rates, complications, pain levels, and how well patients can use their legs.

What are the potential side effects?

Potential side effects may include issues like malalignment (bones not lining up correctly) which is common with current nail systems used for these types of fractures. Other general surgical risks may apply.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Retrograde Femoral Nail-AdvancedExperimental Treatment1 Intervention

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for femur fractures, particularly distal femur or femoral shaft fractures, involve internal fixation methods such as retrograde femoral nailing. This technique involves inserting a metal rod (nail) into the femur from the knee upwards, which is then secured with screws to stabilize the bone fragments. The RFN-advanced Retrograde Femoral Nailing System aims to improve alignment and reduce complications such as malalignment and non-union by providing a more stable and precise fixation. This is crucial for patients as it promotes proper healing, reduces pain, and enhances functional recovery, ultimately leading to better long-term outcomes.

[Retrograde intramedullary fixation of distal femoral fractures].