NCT06286670

Single Versus Dual Implant Fixation of Distal Femur Fractures

Single Implant Versus Dual Implant Fixation of Distal Femur Extra Articular and Complete Articular Fractures - PRORP

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Articular Fractures

Interventions

Type	Name	Description
PROCEDURE	Single Implant Fixation	Single implant fixation with either a precontoured lateral locking plate or an intramedullary nail.
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.

Timeline

• Start date: 2024-09-16
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2024-02-29
• Last updated: 2026-04-07

Locations

16 sites across 1 country: United States