Retrograde Femoral Nail for Broken Bones

Overseen By William Kent, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Severe systemic disease, Pregnancy, Prisoner, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Surgical procedure and immediate recovery

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment RFN-Advanced Retrograde Femoral Nailing System?

The research suggests that retrograde femoral nailing (RFN) is increasingly used for fixing femoral fractures, and it has been compared to other methods like antegrade nailing and femur plate systems. While there are concerns about complications, such as knee arthritis, the studies indicate that RFN can be effective for certain types of fractures, especially when other methods fail. ^{1 2 3 4 5}

Is retrograde femoral nailing generally safe for humans?

Retrograde femoral nailing (RFN) is generally used for fixing broken thigh bones, but there are some safety concerns. Studies have noted potential issues like knee joint arthritis and screw loosening, and there are concerns about knee infections when used for severe open fractures. ^{1 2 3 6 7}

How is the RFN-Advanced Retrograde Femoral Nailing System treatment different from other treatments for broken femur bones?

The RFN-Advanced Retrograde Femoral Nailing System is unique because it uses a retrograde approach, meaning the nail is inserted from the knee area upwards into the femur, which can be beneficial for certain types of fractures, especially those near the knee. This method can be less invasive compared to traditional techniques that require larger incisions and may lead to fewer complications like malunion (improper healing) or nonunion (failure to heal). ^{1 2 3 8 9}

Eligibility Criteria

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.

Inclusion Criteria

Evaluation and treatment at UCSD

I am 18 years old or older.

Ability to understand the content of the patient information/Informed Consent Form

Exclusion Criteria

My doctor has chosen a specific method to fix my injury.

Doctor's determination of unsuitability for participation in the study

Pregnancy or women planning to conceive within the subject participation period (1 year) - self-reported

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the RFN-advanced Retrograde Femoral Nailing System implant for fracture fixation

Surgical procedure and immediate recovery

Follow-up

Participants are monitored for functional status, healing rates, complication rates, and pain levels

3 years

Treatment Details

Interventions

• RFN-Advanced Retrograde Femoral Nailing System

Trial Overview 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.

Participant Groups

Group I: Retrograde Femoral Nail-Advanced Experimental Treatment 1 Intervention

RFN-Advanced Retrograde Femoral Nailing System is already approved in United States, European Union, Canada for the following indications:

Approved in United States as RFN-Advanced Retrograde Femoral Nailing System for:

• Distal femur fractures
• Femoral shaft fractures

Approved in European Union as T2 Alpha Femur Retrograde Nailing System for:

• Distal femur fractures
• Diaphyseal femur fractures

Approved in Canada as RFN-Advanced Retrograde Femoral Nailing System for:

• Distal femur fractures
• Femoral shaft fractures

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

DePuy Synthes

Industry Sponsor

Trials

33

Recruited

4,900+

Findings from Research

A study on sheep demonstrated that retrograde femoral nailing (RFN) can lead to the development of patellofemoral osteoarthritis, particularly affecting the patellofemoral joint over time.

The research suggests caution when using RFN for femoral fractures, especially in healthy young adults, due to the potential risk of osteoarthritis associated with the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early patellofemoral osteoarthritis caused by an osteochondral defect after retrograde solid nailing of the femur in sheep. Pingsmann, A., Lederer, M., Wüllenweber, C., et al.[2019]

In a study of 49 patients with high-grade open femoral shaft fractures treated between 2006 and 2016, retrograde femoral nailing (RFN) did not result in any cases of septic arthritis of the knee, indicating its safety for this type of injury.

The outcomes for RFN were comparable to antegrade femoral nailing (AFN) in terms of infection rates, non-union rates, and overall function, suggesting that RFN is a viable alternative for treating severe open femoral fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial definitive treatment of open femoral shaft fractures with retrograde nailing - is it safe? A retrospective analysis comparing antegrade to retrograde nailing. Davidson, A., Houri, SS., Cohen, J., et al.[2022]

In a study of 42 patients with periprosthetic supracondylar femoral fractures, both the femur plate system (FP) and retrograde-inserted supracondylar nail (RISN) showed similar clinical outcomes, with no significant differences in time to clinical union or overall complication rates.

However, there was a trend indicating higher non-union rates with the FP method and higher re-fracture rates with the RISN method, highlighting the need for careful management of elderly patients who are at greater risk for complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Periprosthetic supracondylar femoral fractures following total knee arthroplasty: clinical comparison and related complications of the femur plate system and retrograde-inserted supracondylar nail. Gondalia, V., Choi, DH., Lee, SC., et al.[2022]

In a study of 13 patients with locking compression plate (LCP) failures, retrograde intramedullary nail (RIN) revision surgery demonstrated significant improvements in both range of motion (ROM) and Hospital for Special Surgery (HSS) scores, indicating effective recovery from the initial surgery.

The average healing time for fractures was 6.5 months, with a low complication rate of 15.38%, suggesting that RIN revision surgery is a safe and effective option for addressing LCP failures in distal femoral fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of revision with retrograde intermedullary nailing for failed plating of distal femoral fractures: a retrospective study. Yuan, Y., Luo, B., Hao, Q., et al.[2021]

The Trochanteric Fixation Nail-Advanced (TFN-A) shows early promise as a comparable alternative to older proximal femur implants, with all 34 patients maintaining neck-shaft angles within 5 degrees of the contralateral hip post-surgery, indicating effective fixation.

No cases of anterior cortical impingement or perforation were reported, suggesting that the TFN-A may successfully address complications seen in previous implant designs, although further investigation into the incidence of 'retrograde cement filling' is warranted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Experience with the Trochanteric Fixation Nail-Advanced (TFN-A): A Descriptive Review of Thirty-Four Cases from a Single Center. Unsay, JC., Chua Tjun Huat, I., Kwek Beng Kee, E.[2022]

In a study of 27 patients who underwent retrograde femoral nailing with the DePuy Synthes RFN-Advanced system, 30% experienced backout of distal interlocking screws, indicating a significant complication rate.

The backout occurred on average 61 days post-surgery, leading to patient discomfort and prompting some to undergo additional surgery for removal, highlighting the need for further investigation into this issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Backout of Distal Interlocking Screws After Retrograde Femoral Nailing With a Novel Device: A Case Series. Minhas, A., Berkay, F., Hudson, T., et al.[2023]

In a study involving 18 sheep, retrograde intramedullary nailing through the distal femoral physis was found to be safe with up to 7% cross-sectional area violation, allowing for continued growth without significant inhibition.

However, violating 8% of the physis resulted in notable growth discrepancies, indicating that careful consideration of implant size is crucial to avoid potential growth disturbances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consequences Following Distal Femoral Growth Plate Violation in an Ovine Model With an Intramedullary Implant: A Pilot Study. Knapik, DM., Zirkle, LG., Liu, RW.[2018]

In a study of 47 patients with distal femur fractures treated with retrograde nailing, all fractures healed within an average of 12.6 weeks, demonstrating the efficacy of this method for fracture stabilization.

The study found that retrograde nailing resulted in a low incidence of complications, with no significant differences in outcomes between AO type A and type C fractures, suggesting it is a safe and effective alternative to plate osteosynthesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrograde fixation of distal femoral fractures: results using a new nail system. Seifert, J., Stengel, D., Matthes, G., et al.[2022]

The retrograde femoral nail technique was successfully used to treat 6 patients with distal femoral fractures, showing good results and potentially reducing complications compared to traditional methods.

This method offers a less invasive approach than classic implants like DCS or condylar blade plates, which are associated with higher rates of malunion and nonunion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Retrograde intramedullary fixation of distal femoral fractures]. Alexa, O., Puha, B., Ciornohac, F.[2011]

References

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

Early patellofemoral osteoarthritis caused by an osteochondral defect after retrograde solid nailing of the femur in sheep. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Initial definitive treatment of open femoral shaft fractures with retrograde nailing - is it safe? A retrospective analysis comparing antegrade to retrograde nailing. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

Periprosthetic supracondylar femoral fractures following total knee arthroplasty: clinical comparison and related complications of the femur plate system and retrograde-inserted supracondylar nail. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Clinical outcomes of revision with retrograde intermedullary nailing for failed plating of distal femoral fractures: a retrospective study. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Early Experience with the Trochanteric Fixation Nail-Advanced (TFN-A): A Descriptive Review of Thirty-Four Cases from a Single Center. [2022]

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

Backout of Distal Interlocking Screws After Retrograde Femoral Nailing With a Novel Device: A Case Series. [2023]

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

Consequences Following Distal Femoral Growth Plate Violation in an Ovine Model With an Intramedullary Implant: A Pilot Study. [2018]

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

Retrograde fixation of distal femoral fractures: results using a new nail system. [2022]

9. Romania pubmed.ncbi.nlm.nih.gov

[Retrograde intramedullary fixation of distal femoral fractures]. [2011]