Single Versus Dual Implant Fixation of Distal Femur Fractures (PRORP)

Wake Forest University (WFU)

Status: Enrolling

Conditions: Articular Fractures

Treatments: Procedure: Single Implant Fixation; Procedure: Dual Implant Fixation

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06286670

HT94252311075 (Other Identifier)

IRB00108312

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

Single Implant Fixation

Other group

Description:

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

Treatment:

Procedure: Single Implant Fixation

Dual Implant Fixation

Other group

Description:

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

Treatment:

Procedure: Dual Implant Fixation