PFN Implant for Hip Fracture

Overseen By Amiethab Aiyer, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Pediatric, Pregnant, Other orthopedic injuries

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

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

Trial Summary

What is the purpose of this trial?

In February 2021, Altior Trauma Innovations™ announced that it had received 501(k) FDA approval for the Artemis Proximal Femoral Nail (PFN) System for internal fixation of intertrochanteric femur fractures. The objective of this pilot study is to evaluate safety, efficacy and feasibility of the Artemis PFN implant for operative fixation of intertrochanteric femoral fractures, compared to matched historical control patients who received other implants.

Do I need to stop my current medications for the trial?

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

What data supports the effectiveness of the PFN Implant treatment for hip fractures?

Research shows that the proximal femoral nail (PFN) is effective in treating unstable hip fractures, with a low rate of technical failures and no mechanical failures reported in a study of 191 cases. This suggests that the PFN is a reliable option for stabilizing hip fractures. ^{1 2 3 4 5}

Is the PFN implant generally safe for treating hip fractures?

The PFN implant has been studied for treating hip fractures and is generally considered safe, with complications mainly related to surgical technique rather than the implant itself. Studies show it has a low rate of technical failures and no mechanical failures like bending or breaking. ^{2 4 6 7 8}

How is the PFN implant treatment for hip fractures different from other treatments?

The PFN implant is unique because it is a minimally invasive treatment that allows for immediate full weight bearing in most patients, unlike other treatments that may require longer recovery times. It is designed to be mechanically strong and stable, reducing the risk of complications like implant failure or additional fractures. ^{2 6 9 10 11}

Research Team

Amiethab Aiyer, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for adults with stable intertrochanteric femur fractures needing internal fixation. It's not open to children under 18, pregnant women, or patients with other orthopedic injuries.

Inclusion Criteria

All patients with traumatic, non-pathologic stable intertrochanteric fractures requiring cephalomedullary nail fixation

Exclusion Criteria

Pregnant females

Patients with other concomitant orthopaedic injuries

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Assessment of preoperative pain and function

30 days

Operative

Participants undergo surgery with the Artemis Proximal Femoral Nail implant

Intraoperative

Postoperative

Monitoring of postoperative function, radiographic healing, and complications

Up to 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 6 months

Treatment Details

Interventions

• Artemis Proximal Femoral Nail (PFN) implant

Trial Overview The Artemis Proximal Femoral Nail (PFN) System is being tested for fixing broken hip bones near the top of the thigh bone. The study compares its safety and effectiveness to past methods used on similar patients.

Participant Groups

Group I: Artemis Proximal Femoral Nail (PFN) implant Experimental Treatment 1 Intervention

All participants will receive the Artemis Proximal Femoral Nail (PFN) implant.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Innov8ortho

Collaborator

Trials

1

Recruited

20+

Findings from Research

In a study of elderly patients with femoral intertrochanteric fractures, femoral head replacement resulted in better hip function recovery one year post-surgery (90.28% excellent/good rate) compared to proximal femoral nail anti-rotation (76.39%).

While femoral head replacement involved longer surgical times and more blood loss, it led to a shorter hospital stay and earlier weight-bearing, suggesting that the choice of surgical method should be tailored to individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Proximal Anti-Rotation Intramedullary Nail and Femoral Head Replacement for the Treatment of Femoral Intertrochanteric Fractures in Elderly Patients. Bi, C., Zhao, Y., Ma, Z., et al.[2023]

The new proximal femoral nail (PFN) was tested in a study involving 191 patients across 4 European clinics, showing a low technical failure rate of only 4.6% after at least 4 months of follow-up.

Unlike existing intramedullary devices, the PFN demonstrated no mechanical failures such as bending or breaking, indicating it may be a safer and more effective option for treating unstable pertrochanteric femoral fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The AO/ASIF-proximal femoral nail (PFN): a new device for the treatment of unstable proximal femoral fractures. Simmermacher, RK., Bosch, AM., Van der Werken, C.[2022]

The study involved 94 elderly patients with intertrochanteric fractures, showing that using a mesh locator to assist in PFNA implantation significantly reduced operation time, incision length, and intraoperative blood loss compared to conventional methods.

Both methods resulted in similar healing times and hip function scores post-surgery, indicating that the mesh locator technique is a feasible and effective option without increasing complication rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of proximal femoral nail antirotation assisted by mesh locator for intertrochanteric fracture in the elderly]. Wu, X., Li, G., He, G., et al.[2023]

The proximal femoral nail antirotation (PFNA) system demonstrated a high union rate in treating unstable intertrochanteric femoral fractures, with all 90 patients achieving fracture union after surgery.

PFNA surgery had a mean operation time of 36.8 minutes and allowed for early postoperative mobilization, making it an effective and efficient treatment option for this type of fracture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Proximal femoral nail for the treatment of unstable intertrochanteric femoral fractures]. Ye, PH., Huang, L., Zha, NF., et al.[2016]

In a study of 158 elderly patients with pertrochanteric femoral fractures, those treated with the proximal femoral nail antirotation (PFNA) showed better postoperative function and fewer complications compared to those treated with the proximal femoral nail (PFN).

The PFNA group had a significantly lower rate of screw cutout (2.4%) compared to the PFN group (11.0%), indicating a safer and more effective fixation method for these types of fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does proximal femoral nail antirotation achieve better outcome than previous-generation proximal femoral nail? Baek, SH., Baek, S., Won, H., et al.[2020]

The Talon™ DistalFix™ Proximal Femoral Nail (Talon-PFN) was evaluated in a study of 110 patients with intertrochanteric femoral fractures, showing it can be a suitable alternative to existing nail designs with similar clinical and radiological outcomes.

Despite a high overall mortality rate of 50.48% during follow-up and various complications such as nonunion and malunion in nearly half of the patients, only a small percentage (5.5%) required revision surgery, indicating that while complications are common, the device's overall effectiveness remains comparable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and radiological outcomes of patients treated with the talon distalfix proximal femoral nail for intertrochanteric femur fractures. Yapici, F., Ucpunar, H., Camurcu, Y., et al.[2021]

In a study involving 424 patients (211 with proximal femoral nail and 213 with gamma nail), the proximal femoral nail (PFN) resulted in significantly lower intra-operative blood loss compared to the gamma nail (220 ml vs 287 ml).

While both implants showed similar functional outcomes and fracture consolidation, the PFN had a higher rate of lateral protrusion of hip screws (7.6% vs 1.6%), indicating a potential complication related to its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of unstable trochanteric fractures. Randomised comparison of the gamma nail and the proximal femoral nail. Schipper, IB., Steyerberg, EW., Castelein, RM., et al.[2022]

In a meta-analysis of 12 studies involving 1,015 elderly patients with intertrochanteric femoral fractures, the proximal femoral nail antirotation (PFNA) showed shorter operation times and less intraoperative bleeding compared to the InterTAN nail, indicating a potential safety advantage during surgery.

However, the InterTAN nail demonstrated better stability and fewer postoperative complications, suggesting it may be a more reliable option for preventing internal fixation failure and allowing earlier functional recovery, despite both methods showing similar long-term efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[PFNA and InterTAN intramedullary nailing in elderly patients with femoral intertrochanteric fractures: a Meta analysis]. Yu, C., Jiang, LH., Cai, DW., et al.[2019]

The proximal femoral nail (PFN) is an effective minimally invasive device for treating unstable proximal femoral fractures, achieving near-anatomic reduction in 34 out of 55 patients in a study conducted from 1997 to 2000.

Despite allowing immediate full weight bearing in most patients, complications occurred in 12 patients, highlighting the importance of careful surgical technique; if open reduction is needed, a dynamic hip screw (DHS) is preferred for complex fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The proximal femoral nail (PFN)--a minimal invasive treatment of unstable proximal femoral fractures: a prospective study of 55 patients with a follow-up of 15 months. Boldin, C., Seibert, FJ., Fankhauser, F., et al.[2022]

In a retrospective review of 26 cases over two years, the use of proximal femoral nails (PFN) for unstable intertrochanteric femur fractures resulted in shorter operating times and less blood loss during surgery.

The study found that PFN had low rates of early complications and no long-term complications, indicating it is a safe and effective option for this type of fracture treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proximal femoral nail in intertrochanteric femoral fractures. Mehboob, I.[2016]

In a study of 133 patients aged 78.4 years treated with proximal femur nails (PFN) for femur fractures, 31.7% experienced complications, highlighting the need for careful surgical technique and monitoring.

Despite being an appropriate treatment for per-, inter-, and subtrochanteric fractures, the clinical outcomes were unsatisfactory in elderly patients, with only 33.8% achieving normal ambulation and a significant risk of implant failure in those with complex fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment results and complications after PFN osteosynthesis]. Hohendorff, B., Meyer, P., Menezes, D., et al.[2022]

References

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

Comparison of Proximal Anti-Rotation Intramedullary Nail and Femoral Head Replacement for the Treatment of Femoral Intertrochanteric Fractures in Elderly Patients. [2023]

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

The AO/ASIF-proximal femoral nail (PFN): a new device for the treatment of unstable proximal femoral fractures. [2022]

3. China pubmed.ncbi.nlm.nih.gov

[Effectiveness of proximal femoral nail antirotation assisted by mesh locator for intertrochanteric fracture in the elderly]. [2023]

4. China pubmed.ncbi.nlm.nih.gov

[Proximal femoral nail for the treatment of unstable intertrochanteric femoral fractures]. [2016]

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

Does proximal femoral nail antirotation achieve better outcome than previous-generation proximal femoral nail? [2020]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical and radiological outcomes of patients treated with the talon distalfix proximal femoral nail for intertrochanteric femur fractures. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Treatment of unstable trochanteric fractures. Randomised comparison of the gamma nail and the proximal femoral nail. [2022]

8. China pubmed.ncbi.nlm.nih.gov

[PFNA and InterTAN intramedullary nailing in elderly patients with femoral intertrochanteric fractures: a Meta analysis]. [2019]

9. England pubmed.ncbi.nlm.nih.gov

The proximal femoral nail (PFN)--a minimal invasive treatment of unstable proximal femoral fractures: a prospective study of 55 patients with a follow-up of 15 months. [2022]

10. Nepal pubmed.ncbi.nlm.nih.gov

Proximal femoral nail in intertrochanteric femoral fractures. [2016]

11. Germany pubmed.ncbi.nlm.nih.gov

[Treatment results and complications after PFN osteosynthesis]. [2022]