Replacement vs Fixation Surgery for Distal Femur Fracture

(DIFFIR Trial)

Overseen By Cassandra Tardif-Theriault, BKin

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Unity Health Toronto

Disqualifiers: Infection, Open fracture, Dementia, others

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

Compensation: Varies

Number of Visits: 3

Duration: Immediate post-surgery to 7 days

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether people with a broken thigh bone near the knee (distal femur fracture) heal better with a knee replacement (distal femoral replacement) or with the usual surgery using plates and screws. For older adults, traditional surgery can lead to issues like the bone not healing or requiring a long period without leg movement. The knee replacement might allow earlier walking and help avoid these problems. The trial seeks participants aged 65 and older who could walk before their injury and recently broke their thigh bone. As an unphased trial, participants contribute to valuable research that may improve recovery options for future patients.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both distal femoral replacement (DFR) and surgical fixation (ORIF) for fractures in the lower thigh bone offer similar safety levels. Studies indicate that both methods have comparable rates of surgical complications and the need for additional surgeries. Some studies highlight high rates of additional surgeries to fix or replace the implant in DFR, along with a significant risk of death, particularly in older patients. However, other research suggests DFR can be a safe and reliable treatment for these fractures.

Surgical fixation also carries risks, such as infections and improper bone healing. Both treatments are commonly used, and surgeons performing these procedures are trained and experienced in knee surgeries. Overall, while both treatments have their risks, they are generally considered safe options for treating fractures in the lower thigh bone in older adults. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the approaches to treating distal femur fractures because they offer distinct options compared to the typical surgical fixation. Distal femoral replacement (DFR) is unique because it involves replacing the damaged part of the femur with a prosthesis, which includes a hinged total knee replacement. This could provide a more stable and long-lasting solution, particularly for patients with severe fractures. On the other hand, surgical fixation, often referred to as ORIF, focuses on realigning and stabilizing the bone using plates and screws. The excitement lies in comparing these methods to determine which offers better outcomes in terms of recovery and mobility for patients dealing with this type of fracture.

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

This trial will compare two surgical methods for treating distal femur fractures: distal femoral replacement (DFR) and surgical fixation (ORIF). Research has shown that DFR helps patients begin moving and recovering quickly, often resulting in good outcomes and fewer complications for those with severe bone damage. Some studies suggest there might not be much difference in hospital stay length between DFR and surgical fixation, which uses plates and screws. However, fixation is usually less expensive, making it more appealing for some. Fixation can sometimes lead to problems like infections and may require additional surgeries. Overall, more research is needed to determine the best method for older patients with these fractures. ^{6 7 8 9 10}

Who Is on the Research Team?

Jesse I Wolfstadt, MD

Principal Investigator

Mount Sinai Hospital, University of Toronto

Amir Khoshbin, MD

Principal Investigator

St Michael's Hospital - Unity Health Toronto

Are You a Good Fit for This Trial?

This trial is for geriatric patients aged 65 or older who have recently suffered a distal femur fracture. They must be able to understand English, French, or Spanish and were walking before the injury, even if they needed aids. The patient should not have had previous major surgeries on the affected leg, no severe dementia, and must consent to participate.

Inclusion Criteria

I have a specific type of broken thigh bone near the knee.

Patient is able to read and understand English, French, or Spanish

My fracture can be treated in more than one way.

Exclusion Criteria

You have been diagnosed with dementia before.

I have not had major blood vessel injuries, severe swelling in limbs, or serious nerve damage needing treatment.

I have had surgery on my knee or near my knee.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either distal femoral replacement or surgical fixation for distal femur fracture

Immediate post-surgery to 7 days

Daily visits while in hospital

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of knee function and pain

24 months

Visits at 3, 6, 9, 12, and 24 months post-surgery

Long-term follow-up

Extended monitoring of participants' health status and quality of life

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Distal femoral replacement
• Surgical Fixation (ORIF)

Trial Overview

The study compares two treatments for elderly patients with knee fractures: surgical fixation using plates and screws versus knee replacement surgery. It aims to determine which method offers better function outcomes, fewer complications, and lower costs.

How Is the Trial Designed?

Group I: Distal femoral replacement (DFR) Experimental Treatment 1 Intervention

Distal femoral replacement will be performed by excising the distal portion of the femur (up to two thirds) and replacing with a prosthesis incorporating a hinged total knee replacement. Surgical approach and implant selection will be at the discretion of the treating surgeon and within the standard of care. Surgeons performing this procedure will be qualified by training and experience in arthroplasty.

Group II: Surgical Fixation (ORIF) Active Control 1 Intervention

Surgical fixation of the distal femoral fracture will be performed with the goals of obtaining and maintaining anatomic reduction and stable fixation of the distal portion of the femur. Surgical approach and implant selection for the surgical fixation (ORIF) will be at the discretion of the treating surgeon and within the standard of care. Surgeons performing this procedure will be qualified by training and experience in trauma of the knee.

Distal femoral replacement is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Distal femoral replacement for:

• Geriatric distal femur fractures
• Severely comminuted fractures
• Osteoarthritis (OA) of the knee

Approved in European Union as Distal femoral replacement for:

• Geriatric distal femur fractures
• Complex fractures
• Previous arthroplasty

Approved in Canada as Distal femoral replacement for:

• Geriatric distal femur fractures
• Severely comminuted fractures
• Osteoarthritis (OA) of the knee

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials

572

Recruited

470,000+

Ascension Providence Rochester Hospital

Collaborator

Trials

1

Recruited

140+

Mount Sinai Hospital, Canada

Collaborator

Trials

210

Recruited

70,700+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

OrthoCincy Orthopaedics & Sports Medicine

Collaborator

Trials

1

Recruited

140+

University of California

Collaborator

Trials

46

Recruited

208,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

University of Calgary

Collaborator

Trials

827

Recruited

902,000+

Rush University Medical Center

Collaborator

Trials

448

Recruited

247,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

Patients undergoing conversion total knee arthroplasty (cTKA) after prior periarticular open reduction and internal fixation (ORIF) have significantly higher rates of complications compared to those undergoing primary total knee arthroplasty (TKA), including all-cause revision (5.47% vs 2.47%) and periprosthetic joint infection (4.74% vs 1.34%).

Surgeons should be aware that cTKA patients are at increased risk for complications such as periprosthetic fractures and should be counseled accordingly, treating them as high risk for infections during the perioperative period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased Revisions in Conversion Total Knee Arthroplasty After Periarticular Open Reduction Internal Fixation Compared With Primary Total Knee Arthroplasty: A Matched Cohort Analysis. Stake, SN., Gu, A., Fassihi, SC., et al.[2021]

In a study of 16,784 patients aged 65 and older with distal femur fractures, only 3.5% required conversion to arthroplasty within 10 years after undergoing open reduction internal fixation (ORIF), indicating that ORIF is a relatively effective long-term treatment option.

There was no significant difference in the 10-year reoperation-free survival rates between patients who had ORIF and those who underwent primary arthroplasty, but primary arthroplasty had a higher rate of acute wound infections (2.0% vs. 0.2%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Geriatric Distal Femur Fractures: Equivalent Long-Term Reoperation Rates Between Fixation and Primary Arthroplasty. Shi, BY., Upfill-Brown, A., Brodke, DJ., et al.[2023]

In a study of 72 patients with displaced periprosthetic distal femur fractures, those treated with open reduction and internal fixation (ORIF) had better Knee Society Functional Scores compared to those treated with distal femoral replacement (DFR).

However, the ORIF group experienced a significantly higher total incidence of revision surgeries, indicating that while ORIF may offer better functional outcomes, it also carries a greater risk of needing additional operations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Periprosthetic Fractures of the Distal Femur: Is Open Reduction and Internal Fixation or Distal Femoral Replacement Superior? Darrith, B., Bohl, DD., Karadsheh, MS., et al.[2021]

A systematic review of 32 studies involving 1,258 periprosthetic distal femur fractures found that open reduction and internal fixation (ORIF) and distal femoral replacement (DFR) have similar rates of surgical complications and reoperations, indicating both methods are comparably safe.

However, patients treated with DFR experienced significantly higher medical complication rates (23.1% for DFR vs. 8.5% for ORIF), suggesting that while DFR can be effective, it may carry additional health risks that need to be considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distal Femoral Replacement versus Operative Fixation for Periprosthetic Distal Femur Fractures: A Systematic Review and Meta-Analysis. Bundschuh, KE., Grommersch, BM., Tipton, SC., et al.[2023]

In a retrospective study of patients with periprosthetic distal femur fractures following total knee arthroplasty, no pre-operative factors such as age or fracture characteristics were found to correlate with clinical outcomes after treatment.

However, the presence of callus formation post-surgery was significantly associated with better clinical outcomes, suggesting that monitoring for callus development could be important for predicting recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Assessment of Factors That Influence Outcome Following Fixation of Periprosthetic Distal Femur Fractures Associated with Total Knee Arthroplasty. Fakoya, K., Sedarous, R., Seifo, M., et al.[2023]

In a study comparing distal femoral replacement (DFR) and open reduction and internal fixation (ORIF) for comminuted distal femur fractures, DFR showed a trend towards lower rates of revision and reoperation at 2 years (90% vs. 50% for ORIF), although this was not statistically significant.

Patients treated with DFR experienced significantly higher estimated blood loss (592 mL vs. 364 mL) and longer hospital stays (13 days vs. 6.5 days) compared to those treated with ORIF, indicating a trade-off between potential benefits and increased surgical risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distal femoral replacement versus ORIF for severely comminuted distal femur fractures. Tibbo, ME., Parry, JA., Hevesi, M., et al.[2022]

In a study of 58 patients with periprosthetic distal femur fractures, the type of surgical treatment (open reduction internal fixation or distal femoral replacement) did not significantly affect mortality, complications, or functional recovery after one year.

Age was a critical factor, as older patients (especially those over 85) were more likely to lose their ability to walk and require skilled nursing care, highlighting that age at injury is a stronger predictor of outcomes than the surgical method used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Functional Recovery Following Periprosthetic Distal Femur Fractures. Ruder, JA., Hart, GP., Kneisl, JS., et al.[2022]

Citations

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pmc.ncbi.nlm.nih.gov

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DFRs for comminuted periprosthetic fractures allow immediate mobilization and rehabilitation leading to satisfactory clinical outcomes with low complication ...

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Conclusion: The results of this meta-analysis suggest no proven statistically significant difference between DFR and fixation in terms of length ...

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sciencedirect.com/science/article/abs/pii/S002013832100975X

Cost-effectiveness of fixation versus arthroplasty for ...

Compared to distal femur replacement, ORIF is likely to be a more cost-effective treatment for distal femur fractures in the geriatric patient population.

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cureus.com

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Distal Femoral Replacement After Distal Femur ...

DFR is a viable and effective option for managing periprosthetic distal femur fractures with severe bone loss, especially in patients with multiple ...

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Comparison of Survivorship of Distal Femoral ...

Outcomes of interest included revision rates, revision causes, and DFR survival by fixation method. We identified 243 DFRs for study inclusion: 187 cemented, 30 ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10771596/

High revision rates and mortality after distal femoral ...

This study was initiated to analyze the outcome after distal femoral replacement (DFR) for periprosthetic distal femoral fractures (PDFF).

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orthopedicreviews.openmedicalpublishing.org

orthopedicreviews.openmedicalpublishing.org/article/94574

Distal femoral replacement for the treatment of periprosthetic ...

Distal femoral replacement for the treatment of periprosthetic distal femoral fractures around a total knee arthroplasty: a meta-analysis.

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arthroplastyjournal.org

arthroplastyjournal.org/article/S0883-5403(23)00064-5/fulltext

Distal Femoral Replacement versus Operative Fixation for ...

ORIF and DFR for the treatment of periprosthetic distal femur fractures have similar surgical complication and reoperation profiles.

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0972978X24000746

Outcomes of operatively managed periprosthetic distal ...

Patients with periprosthetic femur fractures have similar time to weight bearing and complications rate with patients with distal femur fracture in native knees ...

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cureus.com

cureus.com/articles/183507-management-of-distal-femur-fractures-replacement-versus-surgical-fixation-versus-conservative-management

Management of Distal Femur Fractures: Replacement ...

This study shows that DFR can be a safe and reliable strategy to manage distal femur fractures. Additional research is required to further ...