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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new implant called the Artemis Proximal Femoral Nail (PFN) to evaluate its safety and effectiveness in fixing certain hip fractures. The focus is on intertrochanteric femur fractures, which occur in the upper part of the thigh bone near the hip. Researchers compare the results to those of patients who received different implants in the past. Individuals with traumatic hip fractures requiring a specific type of nail may qualify for this trial. As an unphased study, this trial provides a unique opportunity to contribute to medical research and potentially benefit from innovative treatment options.

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 prior data suggests that the Artemis PFN implant is safe for hip fracture treatment?

Research has shown that the Artemis Proximal Femoral Nail (PFN) implant is well-tolerated for fixing hip fractures. One study found that using a similar type of nail with extra support led to good implant positioning and excellent healing rates, with fewer post-surgery problems. The Artemis PFN system also has FDA approval for treating certain hip fractures, indicating it meets safety standards for patients. This approval confirms the implant's safety for human use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Artemis Proximal Femoral Nail (PFN) implant is unique because it offers a fresh approach to treating hip fractures by providing enhanced stability and support, which can lead to faster recovery times compared to traditional fixation methods like screws and plates. Unlike standard treatments that may involve more invasive procedures, the Artemis PFN implant is designed to be minimally invasive, potentially reducing surgery time and recovery-related complications. Researchers are excited about this treatment because it could improve patient outcomes by promoting quicker mobilization and reducing the risk of post-surgical complications, which are common concerns with existing options.

What evidence suggests that the Artemis PFN implant is effective for hip fractures?

Research has shown that the Artemis Proximal Femoral Nail (PFN) implant is promising for fixing hip fractures. In a study with 191 patients, the Artemis PFN demonstrated a low failure rate of just 4.6%, indicating its effectiveness in surgeries. The implant also passed safety tests, confirming it meets safety standards. Overall, these findings suggest that the Artemis PFN could be a safe and effective choice for treating hip fractures. Participants in this trial will receive the Artemis PFN implant to further evaluate its effectiveness and safety. ^{2 3 4 5 6}

Who Is on the Research Team?

Amiethab Aiyer, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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]

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]

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]

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-fractures-bone-11-2022-6464e

PFN Implant for Hip Fracture 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% ...

2. ctv.veeva.com ctv.veeva.com/study/artemis-proximal-femoral-nail-for-internal-fixation-of-intertrochanteric-femur-fractures

Artemis Proximal Femoral Nail for Internal Fixation of ... The objective of this pilot study is to evaluate safety, efficacy and feasibility of the Artemis PFN implant for operative fixation of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11211153/

Retrospective evaluation of radiological and clinical outcomes ... Overall reoperation rate after surgical treatment of proximal femoral fractures utilizing the Proximal Femoral Nail Antirotation (PFNA) was 6.8% ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05559736?term=AREA%5BConditionSearch%5D(DCLRE1C)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING%20OR%20AVAILABLE)&rank=8

Study Details | Artemis Proximal Femoral Nail for Internal ... A phase of research to describe clinical trials that gather more information about a drug's safety and effectiveness by studying different populations and ...

5. innov8ortho.com innov8ortho.com/app/uploads/2024/01/C31065-Innov8Ortho-VAP-Docs_ARTEMIS-PFN.pdf

Value Analysis Guide Performance Data The Artemis Proximal Femoral Nail System successfully underwent mechanical testing in accordance with ASTM F1264 and ASTM F543. Performance ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05559736?tab=table

Artemis Proximal Femoral Nail for Internal Fixation of ... The objective of this pilot study is to evaluate safety, efficacy and feasibility of the Artemis PFN implant for operative fixation of intertrochanteric femoral ...