Single vs Dual Implant for Femur Fractures

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Lower extremity fracture, Infection, Metabolic bone disease, others

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

Compensation: Varies

Number of Visits: 1

Duration: Duration of surgery, approximately 2-4 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether using two fixation devices instead of one improves treatment for fractures in the lower part of the thigh bone (distal femur). Participants will receive either a Dual Distal Femur Implant, which may consist of two plates or a plate and rod, or a Single Distal Femur Implant, which may be one plate or one rod. The surgeon will choose the implant type based on the specific fracture. The trial seeks individuals with a distal femur fracture who can walk and require surgery within 72 hours of hospital arrival. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future fracture treatments.

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 these fixation devices are safe for femur fractures?

Research has shown that using two implants for thigh bone (femur) fractures might be safer and more effective than using one. Studies have found that two implants, such as two plates or a plate and a rod, provide strong and stable support. This approach often leads to better healing and fewer complications.

In contrast, some studies suggest that single implants, like just a plate or a rod, might have a higher risk of issues, such as implant failure or improper fracture healing. Despite this, single implants remain commonly used and generally perform well.

Both treatment options aid in regaining function. The choice between them typically depends on the specific needs of the fracture and the surgeon's decision. Overall, both methods are considered safe, but using two implants might offer advantages in certain situations. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the new approaches to treating femur fractures because they offer tailored solutions based on fracture characteristics. Unlike the traditional single implant options, which typically involve using either a plate and screws or a rod, the dual implant approach allows for a combination of implants, potentially increasing stability and promoting better healing. The dual implant technique uses either two plates with screws or a plate and screws combined with a rod, providing more flexibility for surgeons to select the most effective configuration for each specific fracture. This personalized approach could lead to improved outcomes and faster recovery times for patients.

What evidence suggests that this trial's treatments could be effective for femur fractures?

This trial will compare the effectiveness of a Dual Distal Femur Implant versus a Single Distal Femur Implant for treating distal femur fractures. Research has shown that using two implants for thigh fractures might improve healing. Studies indicate that two plates can help difficult fractures heal more effectively. One study found that combining a plate with a rod (nail) results in better outcomes than using two plates alone.

Using just one implant, such as a plate with screws or a rod, has also proven successful. Some studies suggest that single implants may lead to fewer complications and reduce the need for additional surgeries. Both methods aim to stabilize the fracture and aid recovery, but the best choice depends on the specific type of fracture. Participants in this trial will be assigned to either the Dual Distal Femur Implant Group or the Single Distal Femur Implant Group to evaluate these approaches. ^{2 3 6 7 8}

Who Is on the Research Team?

Brandon Yuan, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals who need surgery within 72 hours after arriving at the hospital due to a femur fracture near the knee. They must have been able to walk before the injury and be capable of giving consent themselves or through a family member or power of attorney. People with infections, severe cognitive issues, other major leg fractures, bone diseases like Paget's, open fractures, advanced Parkinson's disease, or significant bone loss are not eligible.

Inclusion Criteria

I have a broken thigh bone below the midsection.

Consent can be granted by the patient, a family member, or an authorized representative.

I was able to walk on my own before.

Exclusion Criteria

I have a broken bone that is exposed through my skin.

I have had a fracture due to weakened bones from my condition.

I have a major fracture in my leg.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgery for distal femur fracture fixation using either dual or single implant

Duration of surgery, approximately 2-4 hours

1 visit (in-person)

Post-surgical Monitoring

Participants are monitored for early post-surgical complications such as VTE, cardiopulmonary, and infectious complications

2 weeks

Follow-up visits as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dual Distal Femur Implant
• Single Distal Femur Implant

Trial Overview The study is comparing two methods of surgical repair for thigh bone (femur) fractures close to the knee: one using a single fixation device and another using two devices. The goal is to see which method is more effective in treating these types of injuries.

How Is the Trial Designed?

Group I: Dual Distal Femur Implant Group Experimental Treatment 1 Intervention

Subjects will receive two implants for fixation of the distal femur fracture. The dual implant will be either 2 plates with screws or a plate with screws and a rod. The type of dual implant used will be determined by the surgeon based on the characteristics of the fracture.

Group II: Single Distal Femur Implant Group Active Control 1 Intervention

Subjects will receive one of two types of implants for the distal femur fracture. The single implant will be either a plate and screws or a rod. The type of single implant used will be determined by the surgeon based on the characteristics of the fracture.

Dual Distal Femur Implant is already approved in European Union, United States for the following indications:

Approved in European Union as Dual Distal Femur Implant for:

• Distal femur fractures
• Complex distal femoral fractures
• Periprosthetic fractures

Approved in United States as Dual Distal Femur Implant for:

• Distal femur fractures
• Complex distal femoral fractures
• Periprosthetic fractures

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Single fixation methods like lateral locking compression plates or retrograde intramedullary nails may not provide enough stability for complex distal femoral fractures, highlighting the need for more robust solutions.

Double fixation constructs, such as double-plate and nail-and-plate systems, have shown high union rates and satisfactory functional outcomes in various types of distal femoral fractures, suggesting they are effective options for improving fracture healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double fixation for complex distal femoral fractures. Stoffel, K., Sommer, C., Lee, M., et al.[2022]

Lateral plating of distal femoral fractures resulted in a significant mean reduction of 21.2% in vascularity, indicating that this method can compromise blood supply to the area.

Adding a medial plate for dual plating did not significantly worsen vascularity, suggesting that dual plating can be a viable option for complex fractures without further damaging blood flow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of dual plating on the vascularity of the distal femur. Rollick, NC., Gadinsky, NE., Klinger, CE., et al.[2020]

In treating complex distal femur fractures in the elderly, using dual-plate or nail-plate combination techniques can enhance fixation stability, allowing for immediate weight-bearing and potentially improving union rates.

These techniques help distribute forces more evenly across the fracture site, which is crucial for effective healing, especially in challenging fracture patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintaining the Neutral Axis in the Treatment of Distal Femur Fractures Via Dual Plate or Nail Plate Combination Technique: When and How? Liporace, FA., Aneja, A., Carroll, EA., et al.[2023]

In a study comparing 30-day outcomes for distal femur fractures, both plate fixation (PF) and intramedullary nail (IMN) treatments showed similar rates of adverse events, serious adverse events, infectious complications, and mortality among 555 patients.

The findings suggest that IMN is as safe and effective as PF for short-term recovery in patients with distal femur fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative adverse events in distal femur fractures treated with intramedullary nail versus plate and screw fixation. Pean, CA., Konda, SR., Fields, AC., et al.[2020]

In a study of 72 patients with distal femur periprosthetic fractures, dual plating (DP) was associated with a significantly higher likelihood of patients being weight-bearing and returning to their baseline ambulatory status by 12 weeks post-surgery compared to single distal femur locking plating (DFLP).

Both treatment methods showed similar outcomes in terms of reoperation rates and alignment, indicating that DP is a safe and effective option for managing these complex fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual Plate Fixation of Periprosthetic Distal Femur Fractures. Andring, NA., Kaupp, SM., Henry, KA., et al.[2023]

A systematic review of 1,188 patients found that both intramedullary nail fixation (IMN) and locked compression plating (LCP) are effective for treating periprosthetic fractures of the distal femur, with no significant differences in union rates or time to union.

However, LCP showed a significantly lower overall complication and reoperation rate compared to IMN, while IMN allowed for quicker full weight bearing and a higher percentage of patients returning to preinjury activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Equivalent union rates between intramedullary nail and locked plate fixation for distal femur periprosthetic fractures - a systematic review. Shah, JK., Szukics, P., Gianakos, AL., et al.[2021]

The integrated dual lag screw (IDL) cephalomedullary nails (InterTan) showed significantly lower complication rates compared to single lag screw (SL) constructs, with reduced risks of all-cause revisions, cut-outs, and screw migration in a meta-analysis of 15 studies involving 2643 patients.

While the InterTan nails had longer operative and fluoroscopy times, there was no significant difference in functional outcomes or other complications between the IDL and SL groups, indicating that IDL nails may be safer but not necessarily more effective in improving patient function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated dual lag screws versus single lag screw cephalomedullary nail constructs: a meta-analysis and systematic review. Onggo, JR., Nambiar, M., Onggo, JD., et al.[2022]

The dual-plate (DP) construct demonstrated superior stiffness in both torsion and compression compared to the plate-nail (PN) construct in a biomechanical study using 24 synthetic femurs and matched pairs of cadaveric femurs.

In cadaveric specimens, the DP construct was nearly twice as stiff in torsion and over one-and-a-half times stiffer in compression than the PN construct, indicating it may provide more effective fixation for supracondylar distal femur fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supplemental Fixation of Supracondylar Distal Femur Fractures: A Biomechanical Comparison of Dual-Plate and Plate-Nail Constructs. Wright, DJ., DeSanto, DJ., McGarry, MH., et al.[2021]

Minimally invasive double-plating of the distal femur was successfully performed on 11 patients, with no implant failures or loss of reduction observed after unrestricted weight bearing, indicating a safe and effective surgical technique for managing complex femoral fractures.

The technique was particularly beneficial for geriatric patients with limited bone stock, as it allowed for successful healing in cases of peri- and interprosthetic fractures, although one patient did experience a fracture-related infection that required further intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally invasive double-plating osteosynthesis of the distal femur. Beeres, FJP., Emmink, BL., Lanter, K., et al.[2020]

Citations

1. nature.com nature.com/articles/s41598-025-14999-6

Comparison of combined femoral nail and plate fixation ... Both fixation strategies provided stable constructs, facilitated early recovery, and resulted in satisfactory functional outcomes. Retrograde ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0020138325001846

Biomechanical comparison of different double plate ... Dual plate fixation results in improved union rates in comminuted distal femur fractures compared to single plate fixation. J Orthop, 18 (2020), pp. 76-79 ...

3. jtraumainj.org jtraumainj.org/journal/view.php?number=1358

Dual plating in the management of nonunion complex ... The purpose of this study was to assess the effectiveness of the dual plate concept in failed cases of distal femur fractures that were ...

4. jocr.co.in jocr.co.in/wp/2025/02/outcomes-of-combined-distal-femur-plating-and-retrograde-femur-nailing-in-comminuted-distal-femur-fractures-case-series-of-seven-cases-with-6-months-follow-up/

Outcomes of Combined Distal Femur Plating and ... The combination of distal femur plating and retrograde femur nailing provides encouraging results for treating comminuted distal femur fractures. This dual ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11965052/

Double plating versus nail–plate construct in AO 33C distal ... Nail–plate constructs seems to lead to significantly better outcomes in AO type C distal femur fractures, compared with double plating, in terms ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8789962/

Dual-Plating in Distal Femur Fracture: A Systematic Review ... Dual plate fixation results in improved union rates in comminuted distal femur fractures compared to single plate fixation. Journal of Orthopaedics. 2019;15 ...

7. arthroplastytoday.org arthroplastytoday.org/article/S2352-3441(24)00141-9/fulltext

Dual Plating for Periprosthetic Distal Femoral Fractures ... We describe the results of a case series of 15 patients who underwent dual plating for acute PDFF from 2015 to 2021 (87% female, median age 78 ...

8. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-025-06309-7

Dual vs. single plating in distal femoral fractures Double plating is a suitable option for periprosthetic distal femur fracture compared to single plate fixation and distal femoral arthroplasty.