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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for repairing broken thigh bones (femur) using the RFN-Advanced Retrograde Femoral Nailing System. The goal is to determine if this implant improves bone healing, reduces pain, and results in fewer complications compared to current methods. It targets individuals requiring surgery for a broken femur who have been evaluated at UCSD. Participants will contribute data on the effectiveness of this new design over a three-year period. As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance future treatment options.

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 prior data suggests that the RFN-Advanced Retrograde Femoral Nailing System is safe for fracture fixation?

Research shows that the RFN-Advanced Retrograde Femoral Nailing System is under testing to help fix broken thigh bones. Studies suggest that this new nail design might improve bone healing and stability. However, there is an 8.2% chance of mechanical failure.

The system is designed to stay in place better, which is crucial for healing fractures in the lower part of the thigh bone. While the results are promising, participants should consider both the potential benefits and risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The RFN-Advanced Retrograde Femoral Nailing System is unique because it offers a new approach to stabilizing broken femur bones by using a retrograde insertion technique. Unlike traditional methods, which often involve antegrade nailing through the hip, this system allows for insertion through the knee, potentially reducing surgical trauma and improving recovery times. Researchers are excited about this treatment because it could lead to fewer complications, faster rehabilitation, and better alignment of the bone, which are significant improvements over current standard care options.

What evidence suggests that the RFN-Advanced Retrograde Femoral Nailing System is effective for broken bones?

Research shows that the RFN-Advanced Retrograde Femoral Nailing System, which participants in this trial will receive, could effectively treat broken thigh bones. Studies suggest that this system may promote better bone healing than older methods, such as using plates on the side of the bone. One study compared the RFN-Advanced system to traditional methods and found promising results in bone healing and alignment. The system improves how the metal rod is secured in the bone, addressing difficulties seen with older designs. Early reports indicate it might reduce issues like incorrect bone healing, a common problem with current methods. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

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

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

Signed and dated IRB-approved written informed consent

Exclusion Criteria

Doctor's determination of unsuitability for participation in the study

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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 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 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 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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40446568/

Comparison of the RFN-advanced femoral nailing system ... This matched cohort study demonstrated promising results comparing the RFNA to lateral plating of distal femur fractures.

2. withpower.com withpower.com/trial/phase-fractures-bone-5-2021-26e29

Retrograde Femoral Nail for Broken Bones 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 ...

3. aofoundation.org aofoundation.org/approved/approvedsolutionsfolder/2020/rfn-advanced-retrograde-femoral-nailing-system

RFN-Advanced Retrograde Femoral Nailing System Retrograde nailing of native and periprosthetic distal femoral fractures can be challenging due to: limited implant anchorage possibilities ...

4. clinicaltrial.be clinicaltrial.be/en/details/188247?per_page=100&recruiting=1&enrolling_by_invitation=0&active_not_recruiting=0&not_yet_recruiting=0&completed=0&only_recruiting=1&only_eligible=0

Retrograde Femoral Nail-Advanced Outcomes for Fixation ... RFN-Advanced Retrograde Femoral Nailing System for patients with a distal femur or femoral shaft fracture requiring surgery. Primary outcomes.

5. jnjmedtech.com jnjmedtech.com/en-US/product/rfn-advanced

RFN-ADVANCED™ Retrograde Femoral Nailing System The RFN-ADVANCED™ System is a retrograde femoral nailing system designed to improve fixation for distal femur fractures1. As part of the Advanced Nailing System ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39774644/

Mechanical Failure of the Stryker T2 Alpha Retrograde ... 8.2% mechanical failure rate of distal femur fractures treated with this new nail compared with no failures observed with any other nail.