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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This research study is being conducted to examine the effect of two versus one fixation device for fixation of distal femur fractures.

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 treatment for femur fractures?

Research shows that using two implants (dual fixation) for complex femur fractures often leads to high healing rates and good functional outcomes. This approach, which includes using two plates or a combination of a plate and a nail, is particularly effective for difficult fracture patterns, helping to stabilize the bone and allow for early weight-bearing. ^{1 2 3 4 5}

Is the double fixation method for femur fractures safe?

Studies on double fixation methods, like double-plate and nail-and-plate constructs, for complex femur fractures show generally high healing rates and satisfactory outcomes, suggesting they are safe for treating these types of fractures. ^{1 4 6 7 8}

How does the dual implant treatment for femur fractures differ from other treatments?

The dual implant treatment for femur fractures, which includes dual plating or a nail-and-plate construct, is unique because it provides increased stability and allows for immediate weight-bearing in complex fracture patterns. This approach can improve fracture healing by maintaining the neutral axis and distributing forces more evenly, which is not typically achieved with single implants like a single plate or intramedullary nail. ^{1 2 4 5 9}

Research Team

Brandon Yuan, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Double fixation for complex distal femoral fractures. [2022]

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

Supplemental Fixation of Supracondylar Distal Femur Fractures: A Biomechanical Comparison of Dual-Plate and Plate-Nail Constructs. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Equivalent union rates between intramedullary nail and locked plate fixation for distal femur periprosthetic fractures - a systematic review. [2021]

5. United States 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? [2023]

6. India pubmed.ncbi.nlm.nih.gov

Perioperative adverse events in distal femur fractures treated with intramedullary nail versus plate and screw fixation. [2020]

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

Integrated dual lag screws versus single lag screw cephalomedullary nail constructs: a meta-analysis and systematic review. [2022]

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

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