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

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to compare two types of surgical fixation in patients with specific kinds of distal femur fractures. The main questions it aims to answer is which operation for distal femur fractures is better for efficient return to work and everyday activities.

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 Single vs Dual Implants for Broken Thigh Bones?

Research shows that using two plates (dual plating) for fixing broken thigh bones can improve healing and reduce the need for additional surgeries compared to using just one plate. This approach has been effective in treating complex fractures in other bones, like the clavicle, by reducing complications and improving stability. ^{1 2 3 4 5}

Is dual implant fixation generally safe for treating broken bones?

Research suggests that dual implant fixation, like dual plating, can improve bone healing but may affect blood flow to the bone, which could impact healing. It has been used in various bone fractures, and while it may reduce the need for additional surgeries in some cases, the safety can vary depending on the specific bone and patient condition. ^{1 2 3 6 7}

How does dual implant fixation differ from other treatments for broken thigh bones?

Dual implant fixation, also known as dual plating, uses two plates to stabilize broken thigh bones, which can improve alignment and support compared to using a single plate. However, it may affect blood flow to the area, potentially impacting healing. This approach is particularly considered for complex fractures where a single plate might not provide enough stability. ^{1 2 6 7 8}

Research Team

Laurence Kempton, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

I have multiple injuries that may stop me from working.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

References

1. Netherlands 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. [2021]

2. England pubmed.ncbi.nlm.nih.gov

The effects of dual plating on the vascularity of the distal femur. [2020]

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

Dual Mini-Fragment Plate Fixation of Midshaft Clavicle Fractures Reduces Risk of Reoperation Compared With Single-Plate Fixation Techniques. [2023]

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

Technical Trick: Supplemental Medial Column Screw Fixation of Distal Femur Fractures Treated With a Laterally Based Locked Plate. [2023]

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

Supplemental Fixation of Supracondylar Distal Femur Fractures: A Biomechanical Comparison of Dual-Plate and Plate-Nail Constructs. [2021]

6. England 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. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Minimally invasive double-plating osteosynthesis of the distal femur. [2020]

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

Dual Plate Fixation of Periprosthetic Distal Femur Fractures. [2023]