Single vs Dual Implants for Distal Femur Fracture

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Major lower extremity fracture, infection, metabolic bone disease, cognitive impairment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores outcomes for individuals over 60 with a specific type of broken thigh bone, known as a distal femur fracture. The researchers aim to determine whether using two implants (metal supports) instead of one leads to better recovery. Participants will receive either a single distal femur implant or a combination of dual distal femur implants to help fix the fracture. Those who could walk before the fracture and require surgery within 72 hours are suitable candidates for this study. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance future treatment options for distal femur fractures.

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 trial coordinators or your doctor.

What prior data suggests that these implants are safe for treating distal femur fractures?

Research has shown that using two plates or a combination of a nail and a plate for dual distal femur implants provides strong support and aids early healing. Studies indicate that these methods have similar rates of failure and complications compared to other surgeries, suggesting they are generally well-tolerated.

For single distal femur implants, which use one plate or nail, meta-analysis research shows they effectively treat fractures. The complications are similar to those with dual implants.

Both dual and single implants are safe options for treating distal femur fractures. Evidence suggests they are generally well-tolerated and have similar safety profiles. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the trial comparing single versus dual implants for distal femur fractures because it could redefine how we stabilize these injuries. Typically, treatment involves using either a single implant like a retrograde intramedullary nail or a plate with screws. The dual implant approach, which combines either two plates or a nail with an additional plate and screws, may offer enhanced stability and quicker healing times. By exploring whether dual implants provide better outcomes, this trial could lead to more effective and reliable treatment options for patients with these challenging fractures.

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

This trial will compare the effectiveness of single versus dual distal femur implants for treating distal femur fractures. Research has shown that using two implants in the lower thigh bone can lead to better recovery for certain fractures. Specifically, studies found that two plates help complex fractures heal well. Older patients with two implants experienced 10 more healthy days at home, indicating better recovery.

Conversely, using one implant also shows promise. The combination of a nail and plate in single implants provides strong support and a 100% healing rate, meaning the bone healed completely. Research supports that single implants can be effective without increasing the risk of complications. Both options offer benefits, depending on the specific needs and type of fracture, and this trial will evaluate these options. ^{3 4 6 7 8}

Who Is on the Research Team?

Justin Haller, M.D.

Principal Investigator

University of Utah Orthopaedics

Are You a Good Fit for This Trial?

This trial is for people over 60 who had a recent femur fracture near the knee and were walking before the injury. They must be able to get surgery within 3 days of arriving at the hospital, and their fractures should be fixable with either one or two metal supports. People with infections, severe cognitive issues, bone diseases like Paget's, very advanced Parkinson's disease, major bone loss in the femur needing grafting, other big leg fractures or blood vessel injuries can't join.

Inclusion Criteria

I was able to walk on my own before.

Informed consent can be obtained from the patient, family member, or power of attorney

I had surgery within 3 days of arriving at the hospital.

Exclusion Criteria

Severe cognitive impairment (Six Item Screener with 3 or more errors)

I have had a blood vessel injury.

I currently have an infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either dual distal femur implants or a single distal femur implant

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Dual distal femur implants
• Single distal femur implant

Trial Overview

The study aims to compare outcomes between older adults with a specific type of leg fracture near the knee treated using either one metal support (like a plate or rod) versus two supports (a combination). The goal is to see which method helps patients recover better.

How Is the Trial Designed?

Group I: Single distal femur implant Experimental Treatment 1 Intervention

Single implant constructs will be either a retrograde intramedullary nail with interlocking screws or a single plate and screw construct.

Group II: Dual distal femur implants Experimental Treatment 1 Intervention

Dual implant constructs will either be an intramedullary nail with an additional plate and screw construct or dual (two plates in any orientation) plate and screw construct.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

The study of 62 patients with comminuted distal femur fractures showed that using hybrid locked medial plating in addition to lateral locked plating significantly improved fracture healing, with a union rate of 93.8% compared to 56.7% in the standard group.

Patients with the hybrid plating experienced a higher rate of healing at 3 months (75% vs. 30%) and had no reoperations, while factors like smoking and fracture translation were linked to delayed healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hybrid locked medial plating in dual plate fixation optimizes the healing of comminuted distal femur fractures: A retrospective cohort study. Liu, JF., Zhou, ZF., Hou, XD., 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]

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 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]

Citations

1.

pmc.ncbi.nlm.nih.gov

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

Dual-Plating in Distal Femur Fracture: A Systematic Review ...

Dual plating leads to a satisfactory union in the comminuted metaphyseal and articular fractures of the distal femur.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40266628/

Dual Implants for Geriatric Distal Femur Fractures Results ...

Geriatric patients treated with dual implants for distal femur fractures experienced an additional 10 Healthy Days at Home90 as compared to those treated with ...

3.

nature.com

nature.com/articles/s41598-025-99271-7

The impact of medial-first dual plating for reduction of distal ...

Medial-first dual-plate fixation showed better radiographic and comparable clinical results compared to lateral single-plate fixation in treating DFF.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06286670

Single Versus Dual Implant Fixation of Distal Femur Fractures

The goal of this clinical trial is to compare two types of surgical fixation in patients with specific kinds of distal femur fractures.

5.

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 ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12179451/

Dual Construct for Very Low Periprosthetic Distal Femur ...

A dual construct by dual-plating or nail-plate combination in very low PPDFF ensures fracture fixation stability with early union and allows safe, immediate ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1048666623000216

Dual Implant Constructs in Geriatric Distal Femur Fractures

Outcome studies on patients undergoing dual plate fixation demonstrate successful results with similar rates of failure and complication to other operative ...

8.

jmsronline.in

jmsronline.in/archive-article/Dual-implantation-distal-end-femur-fractures-patients-Karnataka

Outcome of dual implantation in distal end femur fractures ...

Data on detailed characteristics of each fracture, including laterality, type, knee derangement, mode of injury, and associated injuries, were also collected.