Dynamic Locking Screws 5.0 vs. Standard Locking Screws in Fracture of Distal Femur Treated With Locked Plate Fixation

A Multi-Center Randomized Controlled Pilot Study of Dynamic Locking Screws 5.0 vs. Standard Locking Screws in Fracture of Distal Femur Treated With Locked Plate Fixation

The purpose of this study is to evaluate the performance of Dynamic Locking Screws (DLS) used to stabilize the shaft component of distal femur fractures in comparison to standard locking screws (SLS). The hypothesis is that DLS will lead to better functional outcomes (WOMAC score) due to increased and more symmetrical callus formation and fewer non-unions.

Inclusion Criteria:

• 21 years and older
• Closed or open distal femur fracture (AO 33 A1-3, 33 C1-3) including distal femur fractures above a total knee arthroplasty
• Ability to walk independently prior to injury
• Eligible for treatment with ORIF of the distal femur with a large fragment locking plate (LISS, LCP)
• Willing and able to comply with post-operative protocol and return for follow-up.
• Ability to understand the content of the patient information / informed consent form and participate in the clinical investigation
• Signed informed consent

Exclusion Criteria:

• Additional ipsi- or contralateral lower extremity fracture
• Any kind of implant at the ipsilateral proximal femur
• Pre-existing malunion or nonunion of the ipsilateral lower extremity
• Segmental bone defect requiring bone grafting
• More than 4 weeks between injury and surgery
• Pathologic fracture due to a disease other than osteoporosis (eg, tumor, metastasis)
• Polytrauma
• Active malignancy
• Any not medically managed severe systemic disease
• Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
• Pregnancy or women planning to conceive within the study period
• Prisoner
• Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study