Single Versus Dual Implant Fixation of Distal Femur Fractures
Purpose
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.
Condition
- Articular Fractures
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- 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 Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other Single Implant Fixation |
Single implant fixation with either a precontoured lateral locking plate or an intramedullary nail. |
|
|
Other 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. |
|
Recruiting Locations
Birmingham 4049979, Alabama 4829764 35233
More Details
- Status
- Recruiting
- Sponsor
- Wake Forest University Health Sciences
Detailed Description
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.