Implant Fixation for Distal Femur Fractures

Recruiting at 1 trial location

Overseen By Abdel-Rahman Lawendy, MD, FRCS(C)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Disqualifiers: Arthroplasty candidate, Loose implant, Open fractures, others

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

Compensation: Varies

Number of Visits: 13

Duration: Immediate post-surgery

44 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to fix fractures in the thighbone near the knee, a common injury in older adults or those with conditions like osteoporosis or diabetes. The researchers aim to determine if using two implants improves recovery and bone healing more than one implant. Participants will receive either a single implant or a dual implant and will attend follow-up visits to monitor their recovery. This study suits adults who have experienced a thighbone fracture within the last two weeks and have conditions like osteoporosis or obesity. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance treatment options 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. It's best to discuss this with the trial coordinators or your doctor.

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

Studies have shown that both single and dual implant methods for fixing fractures in the lower thigh bone are generally safe for patients. Research comparing these methods has found no major differences in safety. Both approaches lead to stable bone healing and quick recovery.

For dual implant fixation, reviews indicate that it usually results in good to excellent outcomes for most patients. Importantly, no reports of implant failure have emerged, meaning they remain secure after surgery.

Overall, patients receiving either single or dual implants for these fractures can expect similar safety, with low chances of complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the dual implant fixation technique for distal femur fractures because it offers a potentially stronger and more stable repair compared to traditional single implant methods. Unlike the standard approach, which typically uses just one implant like a lateral locked plate or a retrograde intramedullary nail, the dual implant technique combines either two plates or a nail and a plate. This dual approach could enhance the healing process by providing additional support and reducing the risk of complications, making it an appealing option for patients with complex fractures.

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

This trial will compare dual implant fixation (DIF) with single implant fixation (SIF) for treating fractures in the lower thigh bone, near the knee. Studies have shown that DIF can effectively treat these fractures. Research indicates that using both a rod (nail) and a metal plate provides strong support, aiding proper bone healing and improving knee movement. Patients treated with DIF often experience better recovery and quality of life than those treated with a single implant. Additionally, using two plates proves helpful for complicated fractures, especially if initial treatment with one implant fails. Overall, DIF shows promise for aiding recovery from these types of fractures. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for older adults or those with conditions like osteoporosis, obesity, bone comminution, or diabetes who have a specific type of thigh bone fracture near the knee (distal femur). They must be able to consent and follow up on treatments. Those with severe open fractures, other major injuries, language barriers without translation, non-walking patients, or certain pre-existing implants cannot join.

Inclusion Criteria

Provision of informed consent

My fracture can be fixed with plates and nails.

I am over 60 or between 18-60 with osteoporosis, obesity, bone fragmentation, or diabetes.

Exclusion Criteria

Ipsilateral hip implant

I have a severe open fracture.

Likely problems, in the judgment of the investigators, with maintaining follow-up (i.e., no fixed address, mentally competent to give consent, etc.)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to receive either single implant fixation (SIF) or dual implant fixation (DIF) for distal femur fractures

Immediate post-surgery

1 visit (in-person) for surgery

Follow-up

Participants will visit the clinic for follow-ups and assessments of their recovery and bone healing, including potential ultrasound imaging for detecting complications like non-union

12 months

Multiple visits (in-person) over 12 months

Long-term Follow-up

Participants are monitored for functional ability and quality of life outcomes, including assessments like the Oxford Knee Score and EQ5D

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Dual Implant Fixation
• Single Implant Fixation

Trial Overview The study compares two surgical methods for fixing thigh bone fractures near the knee in vulnerable adults: Single Implant Fixation (SIF) versus Dual Implant Fixation (DIF). Participants will be randomly assigned to one method and monitored through clinic visits to assess recovery and complications.

How Is the Trial Designed?

Group I: Group B (Experimental): Dual Implant Fixation (DIF) Active Control 1 Intervention

Patients in this arm will undergo fixation using dual implants, either dual plate fixation or a combination of nail and plate fixation.

Group II: Group A (Control): Single Implant Fixation (SIF) Active Control 1 Intervention

Patients in this arm will undergo fixation of distal femur fractures using a single implant, which could be a lateral locked plate or a retrograde intramedullary nail.

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

Orthopaedic Trauma Association

Collaborator

Trials

34

Recruited

5,100+

Published Research Related to This Trial

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]

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]

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]

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]

Single fixation methods like lateral locking compression plates or retrograde intramedullary nails may not provide enough stability for complex distal femoral fractures, highlighting the need for more robust solutions.

Double fixation constructs, such as double-plate and nail-and-plate systems, have shown high union rates and satisfactory functional outcomes in various types of distal femoral fractures, suggesting they are effective options for improving fracture healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double fixation for complex distal femoral fractures. Stoffel, K., Sommer, C., Lee, M., et al.[2022]

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]

Citations

1. 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11965052/

Double plating versus nail–plate construct in AO 33C distal ... Double plating versus nail–plate construct in AO 33C distal femur fractures: treatment choice affects knee alignment, clinical outcomes, and quality of life

3. 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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2773157X25000670

“Redefining success in failed distal femur fracture fixations ... These biomechanical results affirm the nail plus plate construct's effectiveness in distal femur fracture fixation which are also observed in our studies.

5. 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 for comminuted fractures of the distal femur can improve knee mobility at 6 months postoperatively, reduce overall postoperative ...

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

Meta-analysis of the clinical efficacy and safety of single ... There was no significant difference between the two groups in terms of excellent knee function rate, fracture healing time, plate fracture, postoperative ...

7. 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.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1048666623000216

Dual Implant Constructs in Geriatric Distal Femur Fractures Outcome studies on patients undergoing dual plate fixation demonstrate successful results with similar rates of failure and complication to other operative ...

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

Dual-Plating in Distal Femur Fracture: A Systematic Review ... Good to excellent outcome was observed in 55–75% patients. There was no difference between the single plate and dual plate fixation with regards to the ...