Single Versus Dual Implant Fixation of Distal Femur Fractures
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Wake Forest University Health Sciences
- Study ID
- NCT06286670
- Status
- Recruiting
Conditions
- Articular Fractures
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Single Implant Fixation — PROCEDURESingle implant fixation with either a precontoured lateral locking plate or an intramedullary nail.
- Dual Implant Fixation — PROCEDUREDual implant fixation with either a lateral locking plate plus an intramedullary nail or a lateral locking plate plus a supplemental medial plate.
Study Details
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.
Key Dates
- Start date
- Sep 16, 2024
- Status verified
- Feb 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 144 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Other: Single Implant FixationSingle implant fixation with either a precontoured lateral locking plate or an intramedullary nail.
- Other: Dual Implant FixationDual implant fixation with either a lateral locking plate plus an intramedullary nail or a lateral locking plate plus a supplemental medial plate.
Primary Outcome Measure
Return to Work - International Physical Activity Questionnaire (IPAQ) Scores [ Time Frame: Week 6 ]
Central Contacts
- Rachel Seymour, PhD704.355.2000
- Christine Churchill, MA704.355.2000
Locations (16)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35233 | Clay Spitler, MD Clay Spitler, MD (PRINCIPAL_INVESTIGATOR) |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | Geoffrey Marecek, MD Joel Arnold Geoffrey Marecek, MD (PRINCIPAL_INVESTIGATOR) |
| Emory University, Grady Memorial Research Hospital | Atlanta | Georgia | 30303 | Morgan Fuller Jason Barron Thomas Large, MD (PRINCIPAL_INVESTIGATOR) |
| Atrium Health Navicent | Macon | Georgia | 31201 | Adithi Shyam Jarrod Dumpe, MD (PRINCIPAL_INVESTIGATOR) |
| Louisiana State University | New Orleans | Louisiana | 70112 | Jessica Rivera, MD Jessica Rivera, MD (PRINCIPAL_INVESTIGATOR) |
| University of Maryland, Shock Trauma Center | Baltimore | Maryland | 21201 | Mark Gage, MD Casey Loudermilk Mark Gage, MD (PRINCIPAL_INVESTIGATOR) |
| NYC Health and Hospital/Bellevue | New York | New York | 10016 | Nina Fisher, MD Ivanka Bhambhani Nina Fisher, MD (PRINCIPAL_INVESTIGATOR) |
| University of North Carolina Chapel Hill | Chapel Hill | North Carolina | 27514 | Andrew Chen, MD |
| Atrium Health Carolinas Medical Center | Charlotte | North Carolina | 28204 | Christine Churchill Laurence Kempton, MD (PRINCIPAL_INVESTIGATOR) |
| Atrium Health Cabarrus | Concord | North Carolina | 28025 | Erica Grochowski Luke Harmer, MD (PRINCIPAL_INVESTIGATOR) |
| Pennsylvania State University | Hershey | Pennsylvania | 17033 | Andrea Myers Jana Davis, MD (PRINCIPAL_INVESTIGATOR) |
| Prisma Health- Upstate | Greenville | South Carolina | 29605 | Kyle Jeray, MD Kyle Adams, MS Kyle Jeray, MD (PRINCIPAL_INVESTIGATOR) |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | Phillip Mitchell, MD Karen Trochez Phillip Mitchell, MD (PRINCIPAL_INVESTIGATOR) |
| University of Texas Medical Branch | Galveston | Texas | 77555 | Burak Altintas, MD (PRINCIPAL_INVESTIGATOR) |
| Inova | Fairfax | Virginia | 22031 | Greg Gaski, MD Greg Gaski, MD (PRINCIPAL_INVESTIGATOR) |
| Valley Health | Winchester | Virginia | 22601 | Kenneth Nelson, MD (PRINCIPAL_INVESTIGATOR) |
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