Single Versus Dual Implant Fixation of Distal Femur Fractures

NCT ID: NCT06286670

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-16

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Fractures of the distal femur are severe and common injuries sustained by Wounded Warriors in combat. Despite advances in implant technology, these injuries continue to have an unacceptably high rate of nonunion (failure to heal) of approximately 20%. This adverse outcome requires additional surgery to achieve fracture healing, which prolongs recovery and further delays return to duty often beyond one year after injury. The goal of this study is to investigate a potential treatment for distal femur fractures that has the potential to improve the likelihood of fracture healing and accelerate return of patient function during the healing process.

Conditions

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Articular Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

adult patients with extra-articular or complete articular distal femur fractures that will be operatively treated recruited from one of the participating sites during the index hospitalization
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Implant Fixation

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

Group Type OTHER

Single Implant Fixation

Intervention Type PROCEDURE

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

Dual Implant Fixation

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

Group Type OTHER

Dual Implant Fixation

Intervention Type PROCEDURE

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

Interventions

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Single Implant Fixation

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

Intervention Type PROCEDURE

Dual Implant Fixation

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age greater than or equal to 18 years
* Surgically treated displaced distal femur extra articular or complete articular fractures

Exclusion Criteria

* Patients with injury features that preclude treatment with 2 implants
* Patients unlikely to follow-up due to homelessness, or planning follow up at another institution
* Body Mass Index (BMI) \> 40
* Injury due to ground level fall
* Patient that speaks neither English or Spanish
* Patients with multisystem injuries that could preclude return to work
* \< 18 years of age
* Prisoner
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurence Kempton, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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University of Alabama Birmingham

Birmingham, Alabama, United States

Site Status NOT_YET_RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Emory University, Grady Memorial Research Hospital

Atlanta, Georgia, United States

Site Status NOT_YET_RECRUITING

Atrium Health Navicent

Macon, Georgia, United States

Site Status RECRUITING

Louisiana State University

New Orleans, Louisiana, United States

Site Status NOT_YET_RECRUITING

University of Maryland, Shock Trauma Center

Baltimore, Maryland, United States

Site Status RECRUITING

NYC Health and Hospital/Bellevue

New York, New York, United States

Site Status NOT_YET_RECRUITING

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States

Site Status NOT_YET_RECRUITING

Atrium Health Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status RECRUITING

Atrium Health Cabarrus

Concord, North Carolina, United States

Site Status RECRUITING

Pennsylvania State University

Hershey, Pennsylvania, United States

Site Status NOT_YET_RECRUITING

Prisma Health- Upstate

Greenville, South Carolina, United States

Site Status NOT_YET_RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status NOT_YET_RECRUITING

University of Texas Medical Branch

Galveston, Texas, United States

Site Status NOT_YET_RECRUITING

Inova

Fairfax, Virginia, United States

Site Status RECRUITING

Valley Health

Winchester, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Rachel Seymour, PhD

Role: CONTACT

704.355.2000

Christine Churchill, MA

Role: CONTACT

704.355.2000

Facility Contacts

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Clay Spitler, MD

Role: primary

Geoffrey Marecek, MD

Role: primary

Joel Arnold

Role: backup

Morgan Fuller

Role: primary

Jason Barron

Role: backup

Adithi Shyam

Role: primary

Jessica Rivera, MD

Role: primary

Mark Gage, MD

Role: primary

Casey Loudermilk

Role: backup

Nina Fisher, MD

Role: primary

Ivanka Bhambhani

Role: backup

Andrew Chen, MD

Role: primary

Nevaeh Nez

Role: backup

Christine Churchill

Role: primary

Erica Grochowski

Role: primary

Andrea Myers

Role: primary

Kyle Jeray, MD

Role: primary

Kyle Adams, MS

Role: backup

Phillip Mitchell, MD

Role: primary

Karen Trochez

Role: backup

Burak Altintas, MD

Role: primary

409-772-1255

Greg Gaski, MD

Role: primary

Ashley Zelaski

Role: primary

540-536-7542

Other Identifiers

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HT94252311075

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00108312

Identifier Type: -

Identifier Source: org_study_id

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