ORIF vs DFR for Distal Femur Fracture

Overseen By Dykes Viginia, DAT

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to repair a broken thigh bone near the knee, which can occur after a knee replacement. The treatments compared are distal femur replacement total knee arthroplasty (replacing part of the thigh bone) and open reduction and internal fixation (surgically repositioning the broken bone and securing it with hardware). The trial aims to determine which method aids in better and faster recovery. Individuals with a specific type of thigh bone fracture near their knee replacement, who are healthy enough for surgery, may be suitable for this study. As an unphased trial, it offers patients the chance to contribute to research that could enhance future treatment options.

Will I have to stop taking my current medications?

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

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

A previous study showed that patients who underwent distal femur replacement (DFR) for fractures around a knee replacement experienced good movement and function. However, a small risk of infection existed, and about one in five required another surgery within four years. Another study found a notable risk of complications for these patients, but the time to start walking again was similar to other treatments.

Research on open reduction and internal fixation (ORIF) found a complication rate of about 14-15%, sometimes necessitating additional surgeries. Common risks include infection, bleeding, and nerve damage. Studies comparing DFR and ORIF indicate that both have similar rates of surgical complications and the need for further surgeries.

Overall, both treatments offer advantages and disadvantages, and the choice may depend on the specific needs and circumstances of each patient. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard approach of open reduction and internal fixation (ORIF) for distal femur fractures, distal femur replacement total knee arthroplasty (DFR) offers a unique solution. This treatment replaces the damaged bone with a prosthetic, potentially reducing recovery time and the risk of complications associated with healing fractures. Researchers are excited because DFR might provide a more durable and long-term solution, especially for patients with complex fractures where traditional methods may fail.

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

This trial will compare two treatments for distal femur fractures: distal femur replacement total knee arthroplasty (DFR) and open reduction and internal fixation (ORIF). Research has shown that replacing the knee joint at the end of the thigh bone (DFR) effectively treats severe bone loss and weak bone quality, enhancing patients' quality of life. Patients often experience fewer complications and better outcomes compared to other treatments.

For fixing broken bones in the lower thigh, ORIF stabilizes fractures using devices like locking plates. Research indicates that patients with closed fractures often achieve excellent recovery with this method. Some studies suggest that ORIF can lead to similar or even better recovery compared to joint replacement in certain situations. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Non-English-speaking patients

I have an infection in my knee replacement.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35093546/

Clinical Outcomes Following Distal Femur Replacement for ... Distal femoral replacement (DFR) is being used to treat such injuries although outcome data are mostly from small case series. ... Arthroplasty, Replacement, Knee ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6583744/

Periprosthetic Distal Femur Fracture after Total Knee ... This study was designed to itemize and analyze the classification of fracture types and their corresponding outcomes in an attempt to provide a better ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0020138323001705

Periprosthetic distal femur fractures around total knee ... This review provides a narrative synthesis of the most contemporary literature regarding distal femoral periprosthetic fractures.

4. boneandjoint.org.uk boneandjoint.org.uk/Article/10.1302/2633-1462.33.BJO-2021-0202.R1

Survivorship, complications, and outcomes following distal ... This study reports the short-term implant survivorship, complications, and risk factors for patients who underwent DFA for non-neoplastic indications.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0968016019301681

Total knee arthroplasty with distal femoral replacement is ... TKA with DFR is a valuable option for patients with a severe bone loss and poor bone quality in the distal femur. DFR restores an acceptable quality of life.

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

High revision rates and mortality after distal femoral ... Every third patient after DFR for PDFF had died and every fifth patient needed revision within 4 years after surgery.

7. 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.

8. 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 ...

9. 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.