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

80 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Dual distal femur implants, Single distal femur implant for distal femur fracture?

Research suggests that using dual implants for distal femur fractures can provide better stability and allow for earlier movement after surgery compared to single implants. This is because dual implants can better support the bone and help it heal properly, leading to improved outcomes for patients. ^{1 2 3 4 5}

Is dual or single implant treatment for distal femur fractures safe?

Research on dual implants for distal femur fractures suggests they are generally safe, but there may be concerns about blood flow to the bone, which could affect healing. ^{1 2 5 6 7}

How does the treatment of dual vs single implants for distal femur fractures differ from other treatments?

The dual implant treatment for distal femur fractures involves using two plates to stabilize the fracture, which can improve mechanical stability and alignment compared to using a single implant. This approach is particularly useful for complex fractures where a single plate might not provide sufficient support, although it may affect blood supply to the bone, potentially impacting healing. ^{1 2 3 5 8}

What is the purpose of this trial?

The investigators overall study objective is to determine the difference in outcomes for patients over 60 years of age with a displaced distal femur fracture treated with dual distal femur implants (dual plate or IMN/plate) vs. a single distal femur implant (plate or IMN).

Research Team

Justin Haller, M.D.

Principal Investigator

University of Utah Orthopaedics

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

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

Dual Plate Fixation of Periprosthetic Distal Femur Fractures. [2023]

2. England pubmed.ncbi.nlm.nih.gov

The effects of dual plating on the vascularity of the distal femur. [2020]

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

What Is the Likelihood of Union and Frequency of Complications After Parallel Plating and Supplemental Bone Grafting for Resistant Distal Femoral Nonunions? [2023]

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

Study of Clinical Results and Functional Outcome of Patients With Distal Femur Fracture Treated With Dual Plating. [2023]

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

Single-stage bilateral distal femur replacement for traumatic distal femur fractures. [2020]

6. Netherlands 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. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Minimally invasive double-plating osteosynthesis of the distal femur. [2020]

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

Impact on periosteal vasculature after dual plating of the distal femur: a cadaveric study. [2022]