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

Trial Summary

What is the purpose of this trial?

The current standard of care for most intra-articular distal femur fractures (above the knee joint) in geriatric patients is a surgical fixation using plates and screws to hold the fracture pieces in the correct position, until the fracture as healed. However, surgical fixation of these complex fractures in geriatric patients, is associated with significant complications, such as non-union (when the broken bone does not heal properly), infection and the need for revision surgery. Additionally, surgical fixation requires prolonged immobilization of of the affected limb (typically around 6-12 weeks post-operatively), which can lead to disability and other complications. Geriatric patients, especially those frail and with cognition impairment, are unable to adhere to the immobilization restrictions, which leads to an increased risk of fixation failure (broken bone does not heal). Another treatment option for those patients is an acute distal femoral replacement (artificial knee), where damaged parts of the knee joint are replaced with artificial prosthesis. This procedure allows patients to walk immediately after the surgery and faster return to previous level of function, therefore avoiding the complications for immobilization. There is a lack of guideline and evidence to suggest which surgical technique is best to provide superior function outcomes, lower complications and reduced costs. The proposed study seeks to answer this question by performing a large clinical trial comparing knee replacement versus surgical fixation in geriatric patients with distal femur fracture.

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 for distal femur fractures?

Research shows that both distal femoral replacement (DFR) and open reduction internal fixation (ORIF) are used for treating distal femur fractures, with studies comparing their outcomes. Some studies suggest that DFR and ORIF have similar long-term reoperation rates, indicating both can be effective options for managing these fractures. ^{1 2 3 4 5}

Is distal femoral replacement or surgical fixation safe for treating distal femur fractures?

Both distal femoral replacement (DFR) and open reduction internal fixation (ORIF) are used to treat distal femur fractures, and studies have looked at their complication rates. While specific safety data is not detailed, these procedures are commonly used, suggesting they are generally considered safe for managing these fractures. ^{1 3 4 5 6}

How does the treatment for distal femur fracture differ from other treatments?

Distal femoral replacement (DFR) is unique because it involves replacing the damaged part of the femur with an artificial implant, which can be beneficial for severe fractures or when traditional fixation methods like ORIF (open reduction and internal fixation) may not be suitable. This approach can offer quicker recovery and better outcomes for certain patients, especially those with complex fractures. ^{1 2 3 4 7}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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 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]

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]

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]

References

1. Poland pubmed.ncbi.nlm.nih.gov

An Assessment of Factors That Influence Outcome Following Fixation of Periprosthetic Distal Femur Fractures Associated with Total Knee Arthroplasty. [2023]

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

Geriatric Distal Femur Fractures: Equivalent Long-Term Reoperation Rates Between Fixation and Primary Arthroplasty. [2023]

3. France pubmed.ncbi.nlm.nih.gov

Distal femoral replacement versus ORIF for severely comminuted distal femur fractures. [2022]

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

Distal Femoral Replacement versus Operative Fixation for Periprosthetic Distal Femur Fractures: A Systematic Review and Meta-Analysis. [2023]

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

Periprosthetic Fractures of the Distal Femur: Is Open Reduction and Internal Fixation or Distal Femoral Replacement Superior? [2021]

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

Predictors of Functional Recovery Following Periprosthetic Distal Femur Fractures. [2022]

7. United States 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. [2021]