ORIF vs DFR for Distal Femur Fracture

Overseen By Marissa Pazik, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Infection, Open fracture, Poly-trauma, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

100 Participants Needed

Trial Summary

What is the purpose of this trial?

Supracondylar femur periprosthetic fractures about a total knee arthroplasty (TKA) are a catastrophic and challenging complication of TKA and unfortunately are increasing in incidence. Fixation of these fractures can be challenging due to altered anatomy for the TKA and the presence of the metallic femoral component and have a relatively high complication rate. As a result, some surgeons elect to treat these fractures with a distal femur replacement total knee arthroplasty (DFR). The purpose of this study is to prospectively evaluate periprosthetic femur fractures treated with ORIF or DFR and compare various outcomes measures (Get up and go times, KOOS Jr score)

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Distal Femur Replacement Total Knee Arthroplasty for Distal Femur Fracture?

Research comparing Distal Femoral Replacement (DFR) and Open Reduction and Internal Fixation (ORIF) for distal femur fractures suggests that both treatments are used for managing these fractures, with studies focusing on comparing complication rates, implant survivorship, and clinical outcomes. Although direct comparisons are limited, pooled data from systematic reviews indicate that both methods have been effective in managing periprosthetic distal femur fractures. ^{1 2 3 4 5}

Is it safe to undergo ORIF or DFR for distal femur fractures?

Research comparing ORIF (open reduction and internal fixation) and DFR (distal femoral replacement) for distal femur fractures shows that both procedures have been studied for their safety, with complication rates being a key focus. While specific safety data for each procedure varies, both have been used in treating similar conditions, indicating a level of safety in humans. ^{1 2 3 4 5}

How does the treatment of distal femur fractures with DFR and ORIF differ from other treatments?

Distal Femur Replacement (DFR) and Open Reduction and Internal Fixation (ORIF) are unique surgical options for treating severe fractures of the lower thigh bone near the knee. DFR involves replacing the damaged bone with a metal implant, which can allow for quicker recovery and mobility, especially in older patients, while ORIF uses metal plates and screws to hold the bone together, which may be more suitable for younger patients with better bone quality. ^{1 2 4 5 6}

Eligibility Criteria

This trial is for English-speaking patients aged 55 or older with specific types of periprosthetic femur fractures (Su Type II or III) who need surgery and are medically fit for it. It excludes those with open fractures, multiple major injuries, knee prosthetic infections, inability to have surgery, or cancer-related fractures.

Inclusion Criteria

I am 55 or older, speak English, and need surgery for a specific type of thigh bone fracture.

Exclusion Criteria

I have a fracture due to cancer.

I have an infection in my knee replacement.

I cannot have surgery for my condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either open reduction internal fixation (ORIF) or distal femur replacement (DFR) for distal femur fractures

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, including Timed Up and Go Test and KOOS Jr assessment

Up to 2 years

Treatment Details

Interventions

• Distal Femur Replacement Total Knee Arthroplasty
• Open Reduction and Internal Fixation

Trial Overview The study compares two surgical treatments for severe knee fractures near a total knee replacement: ORIF (fixing the bone pieces directly) versus DFR (replacing the damaged part of the thigh bone). Outcomes like mobility and knee function scores will be measured.

Participant Groups

Group I: Distal femur replacement total knee arthroplasty (DFR) of distal femur fracture Active Control 4 Interventions

Su Type 2 or 3 periprosthetic distal femur fractures about a total knee after undergoing DFR for a minimum of 2 years

Group II: Open reduction and internal fixation (ORIF) of distal femur fracture Active Control 4 Interventions

Su Type 2 or 3 periprosthetic distal femur fractures about a total knee after undergoing ORIF for a minimum of 2 years

Distal Femur Replacement Total Knee Arthroplasty is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Distal Femur Replacement for:

• Severe osteoarthritis
• Rheumatoid arthritis
• Traumatic arthritis
• Bone tumors
• Periprosthetic fractures

Approved in European Union as Distal Femur Replacement for:

• Severe osteoarthritis
• Rheumatoid arthritis
• Traumatic arthritis
• Bone tumors
• Periprosthetic fractures

Approved in Canada as Distal Femur Replacement for:

• Severe osteoarthritis
• Rheumatoid arthritis
• Traumatic arthritis
• Bone tumors
• Periprosthetic fractures

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Findings from Research

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 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 14 studies found that distal femoral replacement (DFR) and open reduction internal fixation (ORIF) have similar 30-day and 2-year mortality rates in treating periprosthetic distal femur fractures, indicating both methods are safe options.

The reoperation rates were also comparable between DFR (9.3%) and ORIF (14.8%), suggesting that DFR is a reliable treatment, especially for complex fractures where fixation may be challenging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distal femoral replacement or internal fixation for management of periprosthetic distal femur fractures: A systematic review. Lex, JR., Di Michele, J., Sepehri, A., 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]

A meta-analysis of 58 studies involving 1484 patients found no significant differences in complications or reoperation rates between primary distal femoral replacement (DFR) and open reduction and internal fixation (ORIF) for treating periprosthetic distal femur fractures.

However, patients treated with ORIF had a greater mean knee range of motion compared to those treated with DFR, suggesting that while both treatments are similarly safe, ORIF may offer better functional outcomes in terms of mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distal Femur Replacement Versus Open Reduction and Internal Fixation for Treatment of Periprosthetic Distal Femur Fractures: A Systematic Review and Meta-Analysis. Wadhwa, H., Salazar, BP., Goodnough, LH., et al.[2022]

In a study of 38 patients aged 70 and older with distal femur fractures, those who underwent distal femoral replacement (DFR) had better outcomes in terms of mobility, with all DFR patients being ambulatory at one year compared to 25% of those who had open reduction internal fixation (ORIF).

The ORIF group had a significant nonunion rate of 18% and an average time to fracture union of 24 weeks, highlighting potential challenges in recovery compared to DFR, although overall reoperation rates and other outcomes did not show statistically significant differences between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open Reduction vs Distal Femoral Replacement Arthroplasty for Comminuted Distal Femur Fractures in the Patients 70 Years and Older. Hart, GP., Kneisl, JS., Springer, BD., et al.[2018]

References

1. France pubmed.ncbi.nlm.nih.gov

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

2. 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]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Distal femoral replacement or internal fixation for management of periprosthetic distal femur fractures: A systematic review. [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

Distal Femur Replacement Versus Open Reduction and Internal Fixation for Treatment of Periprosthetic Distal Femur Fractures: A Systematic Review and Meta-Analysis. [2022]

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

Open Reduction vs Distal Femoral Replacement Arthroplasty for Comminuted Distal Femur Fractures in the Patients 70 Years and Older. [2018]