Single vs Dual Implants for Broken Thigh Bones

(PRORP Trial)

Recruiting at 18 trial locations

Overseen By Christine Churchill, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Homelessness, BMI > 40, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two different surgeries to repair broken thigh bones, specifically fractures near the knee. The goal is to determine which surgery enables patients to return to work and normal activities more quickly. One group will receive a single implant (Single Implant Fixation), while the other will receive two implants (Dual Implant Fixation). Suitable candidates have a specific type of thigh bone fracture requiring surgery but should not have injuries that prevent the use of two implants. As an unphased trial, this study allows patients to contribute to important research that could enhance surgical outcomes 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.

What prior data suggests that these surgical fixation methods are safe for treating distal femur fractures?

Research has shown that using two implants together is well-tolerated by patients with fractures in the lower thigh bone. Studies indicate that combining two implants, such as a locking plate with an extra nail or plate, leads to good healing. No implant failures occurred, and patients recovered quickly.

For single implant use, deep infections occur in about 1.6% of cases, a known risk for thigh bone repairs. Researchers have studied single implants, like a locking plate or nail used alone, for their stability and effectiveness. These methods are generally considered safe, with manageable risks.

Both methods provide stable support, aiding recovery and helping people return to daily activities. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer new ways to fix broken thigh bones, aiming for better stability and healing. The dual implant fixation uses a combination of a lateral locking plate with either an intramedullary nail or a supplemental medial plate. This approach can enhance support and strength at the fracture site. On the other hand, the single implant fixation simplifies the process with either a precontoured lateral locking plate or an intramedullary nail, potentially reducing surgery time and recovery. These methods could provide more tailored options for patients, improving outcomes compared to traditional single implant techniques.

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

This trial compares the effectiveness of dual implant fixation with single implant fixation for broken thigh bones. Studies have shown that using two implants, as in the dual implant fixation arm of this trial, can lead to strong and stable healing, especially in complicated fractures. This approach helps patients start moving and putting weight on their leg sooner, aiding early recovery. Meanwhile, using one implant, like a plate or a nail, as in the single implant fixation arm, is also effective and costs about the same as using two implants. However, some research suggests that two implants might enhance bone healing, although they could affect blood flow to the bone. Both treatments in this trial aim to help patients return to their daily activities efficiently. ^{1 3 5 6 7}

Who Is on the Research Team?

Laurence Kempton, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for individuals with specific types of distal femur fractures (the bone just above the knee). It's not clear what the exact inclusion or exclusion criteria are, so it would be best to consult the study details or contact the research team directly.

Inclusion Criteria

I had surgery for a severe knee fracture.

Exclusion Criteria

Patients unlikely to follow-up due to homelessness, or planning follow up at another institution

Prisoner

Body Mass Index (BMI) > 40

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical fixation of distal femur fractures using either single or dual implant fixation methods

6 weeks

Multiple visits for surgical procedure and initial recovery

Follow-up

Participants are monitored for safety, effectiveness, and recovery progress, including assessments of pain, physical function, and return to work

12 months

Regular follow-up visits at 6 weeks, 3, 6, and 12 months

Long-term Follow-up

Extended monitoring for post-traumatic arthritis and other long-term outcomes

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Dual Implant Fixation
• Single Implant Fixation

Trial Overview The trial compares two surgical methods: one using a single implant and another using dual implants to fix broken bones in the leg. The focus is on which method allows patients to return to work and daily life more effectively.

How Is the Trial Designed?

Group I: Single Implant Fixation Experimental Treatment 1 Intervention

Single implant fixation with either a precontoured lateral locking plate or an intramedullary nail.

Group II: Dual Implant Fixation Experimental Treatment 1 Intervention

Dual implant fixation with either a lateral locking plate plus an intramedullary nail or a lateral locking plate plus a supplemental medial plate.

Dual Implant Fixation is already approved in European Union, United States for the following indications:

Approved in European Union as Dual Plating for:

• Distal femur fractures
• Periprosthetic distal femur fractures
• Comminuted fractures of the distal femur

Approved in United States as Double Plating for:

• Distal femur fractures
• Periprosthetic distal femur fractures
• Comminuted fractures of the distal femur

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

The study of 62 patients with comminuted distal femur fractures showed that using hybrid locked medial plating in addition to lateral locked plating significantly improved fracture healing, with a union rate of 93.8% compared to 56.7% in the standard group.

Patients with the hybrid plating experienced a higher rate of healing at 3 months (75% vs. 30%) and had no reoperations, while factors like smoking and fracture translation were linked to delayed healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hybrid locked medial plating in dual plate fixation optimizes the healing of comminuted distal femur fractures: A retrospective cohort study. Liu, JF., Zhou, ZF., Hou, XD., et al.[2021]

In a study of 256 patients with displaced midshaft clavicular fractures, dual plating significantly reduced the risk of reoperation compared to single plating techniques, with only 1 reoperation in the dual plating group versus 30 in the single plating groups combined.

Dual plating showed an almost 8-fold lower risk of reoperation compared to single plating methods, highlighting its efficacy in minimizing complications such as nonunion and symptomatic hardware.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual Mini-Fragment Plate Fixation of Midshaft Clavicle Fractures Reduces Risk of Reoperation Compared With Single-Plate Fixation Techniques. Reddy, RP., Charles, S., Como, M., et al.[2023]

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]

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]

In a study of 82 elderly patients with distal femoral fractures, both single-plate and double-plate fixation methods showed similar clinical outcomes, including time to union and knee motion range, indicating that both techniques are effective for this population.

While double-plate fixation offers advantages like better exposure and stability, the study found no significant differences in procedure duration or functional scores between the two methods, suggesting that single-plate fixation may be a viable alternative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractures of the distal femur in elderly patients: retrospective analysis of a case series treated with single or double plate. Nam, DJ., Kim, MS., Kim, TH., et al.[2022]

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]

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]

Using a supplemental medial column screw in addition to lateral plating for distal femur fractures may enhance stability and promote better fracture healing, potentially reducing complications like nonunion and varus collapse.

This method is less invasive compared to dual implant techniques, which can be more complex and costly, suggesting it could be a safer and more efficient option for improving surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical Trick: Supplemental Medial Column Screw Fixation of Distal Femur Fractures Treated With a Laterally Based Locked Plate. Chen, SR., Shaikh, H., Turvey, BR., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8789962/

Dual-Plating in Distal Femur Fracture: A Systematic Review ... Dual plating leads to a satisfactory union in the comminuted metaphyseal and articular fractures of the distal femur.

2. nature.com nature.com/articles/s41598-025-14999-6

Comparison of combined femoral nail and plate fixation ... Both fixation strategies provided stable constructs, facilitated early recovery, and resulted in satisfactory functional outcomes. Retrograde ...

3. eor.bioscientifica.com eor.bioscientifica.com/view/journals/eor/9/6/EOR-23-0160.xml

Meta-analysis of the clinical efficacy and safety of single ... Double plate fixation increases the stability of the internal implant (16, 18), allowing patients to engage in early functional exercises and early weight- ...

4. jtraumainj.org jtraumainj.org/journal/view.php?number=1358

Dual plating in the management of nonunion complex ... Dual plating appears to be an effective approach for managing failed complex distal femur fractures following initial treatment with a single ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06286670

Single Versus Dual Implant Fixation of Distal Femur Fractures The goal of this clinical trial is to compare two types of surgical fixation in patients with specific kinds of distal femur fractures.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11195337/

Meta-analysis of the clinical efficacy and safety of single ... Through meta-analysis, this study aims to comprehensively evaluate the efficacy of single-plating and double-plating in the treatment of comminuted ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2352344124001419

Dual Plating for Periprosthetic Distal Femoral Fractures ... In this study, we report the surgical technique for dual plating PDFFs using an extensile medial or lateral parapatellar approach and illustrate this technique ...